81 FR 7446 - Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 29 (February 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 29 (February 12, 2016)
| Page Range | 7446-7452 | |
| FR Document | 2016-02876 |
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)] [Rules and Regulations] [Pages 7446-7452] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02876] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 868 and 870 [Docket No. FDA-2012-N-1174] Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to class II (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. A membrane lung device for long-term pulmonary support (>6 hours) refers to the oxygenator in an extracorporeal circuit used during long-term procedures, commonly referred to [[Page 7447]] as extracorporeal membrane oxygenation (ECMO). Because a number of other devices and accessories are used with the oxygenator in the circuit, the title and identification of the regulation are revised to include extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. Although an individual device or accessory used in an ECMO circuit may already have its own classification regulation when the device or accessory is intended for short-term use (<=6 hours), such device or accessory will be subject to the same regulatory controls applied to the oxygenator (i.e., class II, special controls) when evaluated as part of the ECMO circuit for long- term use (>6 hours). On its own initiative, based on new information, FDA is revising the classification of the membrane lung device for long-term pulmonary support. DATES: This order is effective February 12, 2016. FOR FURTHER INFORMATION CONTACT: Fernando Aguel, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1234, Silver Spring, MD 20993, 301-796-6326, [email protected]. SUPPLEMENTARY INFORMATION: I. Background--Regulatory Authorities The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures. Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification procedures (510(k)) to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a premarket approval application (PMA) until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval or until the device is subsequently reclassified into class I or class II. On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126 Stat. 1056) amended section 513(e) of the FD&C Act, changing the mechanism for reclassifying a device from rulemaking to an administrative order. Section 513(e) of the FD&C Act provides that FDA may, by administrative order, reclassify a device based upon ``new information.'' FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify a preamendments device. The term ``new information,'' as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., Holland-Rantos Co. v. United States Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).) Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available authority (see Bell, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in light of changes in ``medical science'' (Upjohn, 422 F.2d at 951). Whether data before the Agency are old or new data, the ``new information'' to support reclassification under section 513(e) of the FD&C Act must be ``valid scientific evidence,'' as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Manufacturers Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).) FDA relies upon ``valid scientific evidence'' in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the ``valid scientific evidence'' upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).) Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final reclassification order. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments to a public docket. II. Regulatory History of the Device FDA published a proposed order to reclassify this device in the Federal Register of January 8, 2013 (78 FR 1158) (the ``proposed order''). As noted in the proposed order, on July 16, 1982, the Agency issued a final rule classifying all membrane lungs for long-term pulmonary support into class III (47 FR 31130). On May 11, 1987, FDA published a final rule amending the codified language for this device to clarify that no effective date had been [[Page 7448]] established for the requirement for premarket approval for membrane lungs for long-term pulmonary support devices (52 FR 17732 at 17735). This device is currently under product code BYS. As discussed in the proposed order, FDA considered the available information on these devices and concluded that these devices could be reclassified to class II, subject to the identified special controls. As required by section 513(e)(1) of the FD&C Act, FDA convened a meeting of a device classification panel described in section 513(b) of the FD&C Act with respect to the membrane lung devices for long-term pulmonary support on September 12, 2013, followed by a meeting on May 7, 2014. The deliberations of the device classification panels are discussed in section IV of this order. FDA received and has considered two comments on the January 8, 2013, proposed order, as discussed in section III. Therefore, FDA has met the requirements for issuing a final order under section 513(e)(1) of the FD&C Act. III. Public Comments in Response to the Proposed Order FDA received two comments in response to the January 8, 2013, proposed order to reclassify membrane lung devices for long-term pulmonary support for conditions where imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery. One comment supported FDA's reclassification proposal but requested that the Agency clarify the population covered and the conditions included in the reclassification. According to the commenter, it seemed that the membrane lung device could be used for long-term support in neonates and infants only when imminent death is threatened by cardiopulmonary failure, but for the remaining population (e.g., pediatric and adult patients), the membrane lung could be used for long-term support only when cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery. With respect to the conditions covered, the commenter sought clarification as to whether the reclassification was limited only to cardiopulmonary conditions or to cardiac failure as well. FDA is clarifying the intended uses covered by the reclassification in this final order. Specifically, after considering the input from the September 12, 2013, and May 7, 2014, classification panel meetings, comments on the proposed order and all other available information, FDA has determined that the reclassification applies to ECMO as a system of devices and accessories that provide extracorporeal circulation and physiologic gas exchange of blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. This revised scope better reflects use of ECMO as a tool that provides extracorporeal circulation and physiologic gas exchange of blood and more accurately reflects the function of the device. FDA has not cleared any ECMO devices that are indicated for specific patient populations or conditions. As such, FDA believes that the intended uses included in this final order should remain broad, rather than specify patient populations or conditions to be treated, to reflect use of ECMO as a tool. Another comment disagreed with FDA's intent to reclassify membrane lung devices for long-term pulmonary support, stating that ``ECMO devices must remain categorized as class III devices for all indications because they are life-sustaining devices for which clinical trials are necessary to provide reasonable assurance of safety and effectiveness.'' FDA disagrees with this comment. According to section 513(a)(1)(C) of the FD&C Act, a class III device is defined as a device which: (1) Cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device; and (2) cannot be classified as a class II device because insufficient information exists to determine that the special controls would provide reasonable assurance of its safety and effectiveness; and (3) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health; or (4) presents a potential unreasonable risk of illness or injury. Although FDA considers membrane lung devices for long-term pulmonary support to be life-supporting, a viewpoint that was supported by the panel members at the September 12, 2013 (2013 Panel), and May 7, 2014 (2014 Panel), device classification panel meetings, FDA believes that the available information supports FDA's determination that special controls, in addition to general controls, would be sufficient to provide a reasonable assurance of safety and effectiveness. Further, the 2013 and 2014 Panels largely supported reclassification of ECMO for use in patients with acute respiratory failure or acute cardiopulmonary failure as noted in section IV of this order. As mentioned previously and discussed further in section IV, ECMO is a tool which provides extracorporeal circulation and physiologic gas exchange of blood. The special controls identified in this final order, including clinical performance data, ensure that the device can function as intended to provide extracorporeal circulation and physiologic gas exchange of blood for the intended duration of device use. The Agency believes that the risks of ECMO devices are sufficiently understood based on valid scientific evidence and that the risks of ECMO devices can be mitigated with the special controls identified in this final order. The special controls mitigate the risks to health identified for the device as outlined in section IV, table 1. Therefore, FDA does not agree that membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure should remain a class III device. The commenter also expressed concern that the reclassification of these devices would mean that companies manufacturing new versions of the device would not be required to show that their products are safe and effective. The commenter suggests that classification to class II (special controls) precludes FDA from requesting clinical data for these devices. FDA disagrees with this comment. FDA believes that the identified special controls provide a reasonable assurance of safety and effectiveness for membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. FDA has determined that by complying with the identified special controls, the currently legally marketed devices within this classification regulation will be reasonably safe and effective when used for acute respiratory failure or acute cardiopulmonary failure. Future devices claiming substantial equivalence to an available predicate(s) must demonstrate that they are substantially equivalent, as defined under section 513(i) of the FD&C Act, to the predicate device and comply with all applicable FDA regulations and with the special [[Page 7449]] controls in order to be classified into class II. Classification to class II (special controls) does not preclude FDA from requesting clinical data for these devices. In some cases, clinical data may be needed to comply with the special controls and demonstrate substantial equivalence to an available predicate. For example, special control Sec. 870.4100(b)(v) regarding in vivo evaluation of the device could include clinical trial data, clinical information from the literature, and/or animal study data. The commenter further expressed concern that reclassification for some indications will reduce the incentive to undertake future studies for untested indications due to the availability of the devices for ``off-label'' use. FDA notes in response to this comment that, generally, FDA regulates the use of a device as indicated by the party offering the device for interstate commerce. The commenter also sought assurance from FDA that membrane lung devices for long-term pulmonary support for indications not identified in the proposed order would remain in class III and therefore require the submission of a PMA. FDA notes that by identifying the intended uses covered by the revised classification regulation, uses that fall outside the definition would not be subject to the order but rather would be classified under section 513 of the FD&C Act. IV. Deliberations of the Panels and FDA Consideration of Panel Input As required by section 513(e)(1) of the FD&C Act, FDA convened a meeting of the Circulatory System Devices Panel to consider the existing valid scientific evidence to support reclassification to class II of membrane lung devices for long-term pulmonary support. One meeting was held on September 12, 2013 (2013 Panel), regarding pediatric uses for ECMO and another meeting was held on May 7, 2014 (2014 Panel), regarding adult uses for ECMO (Refs. 1 and 2). On September 12, 2013, FDA presented the risks associated with use of the membrane lung device for long-term pulmonary support. The 2013 Panel mostly agreed that the risks to health were adequately captured as presented by FDA. Several 2013 Panel members discussed whether the list of risks to health should also include information on renal dysfunction, neurologic injury, disseminated intravascular coagulation, transfusion issues, and inflammatory responses. FDA explained that such effects are more appropriately characterized not as risks to health but rather as adverse events that may result from the risks to health. The 2013 Panel understood this distinction but requested that FDA consider expanding the definition of adverse tissue reaction to include inflammatory response. FDA considered the 2013 Panel's input when updating the risks to health for the 2014 Panel and this final order. The 2013 Panel agreed that the available scientific evidence supported the safety and effectiveness for ECMO and its accessories for conditions where the subject is at threat of imminent death caused by acute reversible respiratory failure (e.g., meconium aspiration, congenital diaphragmatic hernia, pulmonary hypertension) in neonates and infants, or where acute cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery in all pediatric patients. The 2013 Panel also agreed that the probable benefits to health from use of the extracorporeal circuit and its accessories for long- term pulmonary and cardiopulmonary support for these uses outweigh the probable risks. As noted previously, FDA has further considered all available information and has determined that the risks to health identified for ECMO are the same across neonatal, infant, pediatric, and adult populations. This is consistent with input from the 2013 and 2014 Panels, which found that the risks to health for the pediatric and adult populations do not differ. Further, FDA believes that the available safety and effectiveness information supports use of ECMO as a tool to provide extracorporeal circulation and physiologic gas exchange of blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. FDA is providing greater clarity in this final order by simplifying the identification of ECMO devices in the classification regulation to better reflect what an ECMO circuit performs, not specify patient populations or conditions to be treated. Specific indications for use for ECMO, including specific patient populations and/or conditions, are further discussed in this document. In general, the 2013 Panel believed the special controls in the proposed order would mitigate the identified risks to health and provide reasonable assurance of safety and effectiveness of the extracorporeal circuit and its accessories. However, some 2013 Panel members recommended that compatibility of the various circuit accessories be evaluated to ensure that the circuit accessories can function together as intended. FDA believes that the special controls will be able to address the issue of circuit accessories' compatibility. Specifically, the following special controls from the classification regulation address this concern: (1) The design characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use; (2) non-clinical performance evaluation of the device must demonstrate substantial equivalence for performance characteristics on the bench, mechanical integrity, electromagnetic compatibility(where applicable), software, durability, and reliability; and (3) labeling must include a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility with other circuit accessories, and maintenance during a procedure. The 2013 Panel unanimously agreed that the membrane lung device for long-term pulmonary support is life-supporting. The 2013 Panel further stated that the available scientific evidence and the proposed special controls, in conjunction with general controls, supported the reclassification to class II of membrane lung devices for long-term pulmonary/cardiopulmonary support in pediatric patients. The 2013 Panel expressed concern about not having had the opportunity to review data regarding use of the device in adults, given that use of ECMO in adults had increased significantly over the years. The 2013 Panel recommended that FDA convene another meeting to review the available literature regarding use of the membrane lung device for long-term pulmonary support in adults before finalizing the proposed reclassification. On May 7, 2014, FDA convened the 2014 Panel to discuss the classification of the membrane lung for long-term support, specifically for adult pulmonary and cardiopulmonary indications. For both pulmonary and cardiopulmonary intended uses, the 2014 Panel believed that the list of risks to health presented by FDA were comprehensive and adequately captured. Of note, in response to the 2013 Panel's recommendation regarding risks to health, FDA expanded the definition of adverse tissue reaction to include inflammatory response. The majority of the 2014 Panel believed that the available scientific evidence is adequate to support a [[Page 7450]] reasonable assurance of safety and effectiveness of the extracorporeal circuit and its accessories for long-term pulmonary support in adults, but recommended that FDA modify the intended use from ``pulmonary support'' to ``acute, hypoxic, reversible respiratory failure.'' FDA agrees with the 2014 Panel that ``respiratory failure'' is a more accurate reflection of the use of ECMO as a tool to provide extracorporeal circulation and physiologic gas exchange of blood in patients rather than ``pulmonary support.'' FDA has considered this input from the panel and has determined that acute respiratory failure is the appropriate intended use from a clinical and regulatory perspective to reflect such use. This change is reflected in the classification regulation. The Panel also agreed that the available scientific evidence is adequate to support a reasonable assurance of safety and effectiveness of the device for long-term cardiopulmonary support in adults suffering from ``cardiopulmonary failure due to acute catastrophic cardiogenic shock.'' FDA agrees with the 2014 Panel that ``acute cardiopulmonary failure'' is a more accurate reflection of the use of ECMO as a tool to provide extracorporeal circulation and physiologic gas exchange of blood in patients rather than ``cardiopulmonary support.'' FDA has considered this input from the panel and has determined that acute cardiopulmonary failure is the appropriate intended use from a clinical and regulatory perspective to reflect such use. This change is reflected in the classification regulation. For both pulmonary and cardiopulmonary support in adults, the 2014 Panel agreed that the probable benefits to health from use of the device outweigh the probable risks to health where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The 2014 Panel agreed that FDA's list of special controls were appropriate and comprehensive. The 2014 Panel further agreed that the special controls would mitigate the identified risks to health and provide reasonable assurance of safety and effectiveness for the device when used to provide long-term support in adults with acute respiratory failure or cardiopulmonary failure. For both acute respiratory and acute cardiopulmonary indications in adults, the 2014 Panel unanimously agreed that the membrane lung device for long-term support is life-supporting. The 2014 Panel further believes that the available scientific evidence and the proposed special controls support the reclassification to class II of membrane lung devices for long-term support in adults with acute respiratory failure or acute cardiopulmonary failure. After considering input from both the 2013 and 2014 Panels, FDA believes that the risks to health identified can be mitigated by the special controls as outlined in Table 1. Table 1--Health Risks and Mitigation Measures for ECMO Devices ------------------------------------------------------------------------ Identified risk Mitigation measures ------------------------------------------------------------------------ Thrombocytopenia....................... Technological characteristics; Non-clinical performance evaluation; In vivo evaluation; Labeling. Hemolysis.............................. Technological characteristics; Biocompatibility testing; Non- clinical performance evaluation; Labeling. Adverse tissue reaction (including Biocompatibility testing; inflammatory response). Labeling. Inadequate gas exchange................ Non-clinical performance evaluation; In vivo evaluation; Labeling. Gas embolism........................... Non-clinical performance evaluation; In vivo evaluation; Labeling. Mechanical failure..................... Technological characteristics; Non-clinical performance evaluation; Labeling. Hemorrhage............................. In vivo evaluation; Labeling. Hemodilution........................... Non-clinical performance evaluation; In vivo evaluation; Labeling. Thrombosis/thromboembolism............. Non-clinical performance evaluation; In vivo evaluation; Labeling. Infection.............................. Sterility; Shelf life testing. Mechanical injury to access vessels.... Non-clinical performance evaluation; In vivo evaluation; Labeling. ------------------------------------------------------------------------ At both the 2013 Panel and 2014 Panel meetings, FDA provided a summary of information from the clinical literature regarding specific patient populations and conditions to be treated using ECMO (Refs.1 and 2). Of note, FDA has not cleared any ECMO devices that are indicated for specific patient populations or conditions. As such, FDA believes that the intended uses included in this final order should remain broad to reflect use of ECMO as a tool to provide extracorporeal circulation and physiologic gas exchange of blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. However, FDA believes that there are specific indications (patient populations and/or conditions) that would fall within this broader intended use and therefore be within the scope of this regulation as outlined in this document. Specifically, FDA has reviewed the clinical literature and has determined that there are sufficient data available to support labeling ECMO devices for the following specific indications (patient populations and/or conditions) at this time: Meconium aspiration in neonates and infants; congenital diaphragmatic hernia in neonates and infants; pulmonary hypertension in neonates and infants; failure to wean from cardiopulmonary bypass following cardiac surgery in pediatric and adult patients; and ECMO-assisted cardiopulmonary resuscitation in adults. FDA has further evaluated data from the clinical literature and determined that the data available do not support labeling ECMO devices for certain specific indications (patient populations and/or conditions) at this time without additional clinical data from sponsors to support such uses, consistent with the identified special controls, including but not limited to: High risk percutaneous coronary intervention; trauma resuscitation; failed heart or lung transplant; acute respiratory distress syndrome; and/or acute decompensation of chronic obstructive pulmonary disease. For ECMO devices that have not been legally marketed prior to the effective date of the final order, or models (if any) that have been legally marketed but are required to submit a new 510(k) under Sec. 807.81(a)(3) because the device is [[Page 7451]] about to be significantly changed or modified, manufacturers must obtain 510(k) clearance, among other relevant requirements, and demonstrate compliance with the special controls included in the final order, before marketing the new or changed device. V. The Final Order Under section 513(e) of the FD&C Act, FDA is adopting its findings as published in the preamble to the proposed order (78 FR 1158) with modifications as discussed in section IV of this final order. FDA is issuing this final order to reclassify the membrane lung devices for long-term pulmonary support from class III to class II for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent, and to establish special controls. FDA is removing the regulation from 21 CFR part 868 (Anesthesiology Devices) and adding it to 21 CFR part 870 (Cardiovascular Devices) to better align this device type (and the review thereof) with other similar types of cardiovascular devices. The title and identification of Sec. 870.4100 (21 CFR 870.4100) reflects the Agency's intent to regulate ECMO and the accessories used in ECMO under the same set of regulatory controls. However, an individual device or accessory in an ECMO circuit may already have its own classification regulation when intended for short- term use (<=6 hours) and, in those instances, such device or accessory is subject to the preexisting regulation(s). Following the effective date of this final order, firms marketing membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent, must comply with the particular mitigation measures set forth in the special controls. Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the devices. FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent, and, therefore, this device type is not exempt from premarket notification requirements. VI. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VII. Paperwork Reduction Act of 1995 This final order refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910- 0120; the collections of information in 21 CFR part 814, subpart B, have been approved under OMB control number 0910-0231; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485. VIII. Codification of Orders Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) of the FD&C Act as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this final order, we are revoking the requirements in 21 CFR 868.5610 related to the classification of membrane lung for long-term pulmonary support as class III devices and codifying under Sec. 870.4100 the reclassification of membrane lung for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent into class II (special controls). IX. References The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. The panel transcript and other meeting materials for the September 12, 2013, Circulatory System Devices Panel are available on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm342357.htm. 2. The panel transcript and other meeting materials for the May 7, 2014, Circulatory System Devices Panel are available on FDA's Web site at. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm395638.htm List of Subjects in 21 CFR Parts 868 and 870 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 868 and 870 are amended as follows: PART 868--ANESTHESIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 868 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. Sec. 868.5610 [Removed] 0 2. Remove Sec. 868.5610. PART 870--CARDIOVASCULAR DEVICES 0 1. The authority citation for 21 CFR part 870 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 870.4100 to subpart E to read as follows: [[Page 7452]] Sec. 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. (a) Identification. An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors). (b) Classification--Class II (special controls). The special controls for this device are: (1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible; (2) The devices and accessories in the circuit must be demonstrated to be biocompatible; (3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories; (4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability; (5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and (6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure. Dated: February 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-02876 Filed 2-11-16; 8:45 am] BILLING CODE 4164-01-P
![7446 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations
regulations designed to help ensure the The Regulatory Flexibility Act Therefore, under the Federal Food,
safety, purity, and potency of the requires Agencies to analyze regulatory Drug, and Cosmetic Act, the Public
licensed product, and that the product options that would minimize any Health Service Act, and under authority
is not misbranded. significant impact of a rule on small delegated to the Commissioner of Food
In addition, FDA continues to help entities. Because this final rule removes and Drugs, 21 CFR part 601 is amended
ensure the safety and effectiveness of regulations that are obsolete and no as follows:
licensed biological products through the longer necessary in light of other current
development and application of statutory and regulatory authorities, PART 601—LICENSING
additional standards and mechanisms. FDA certifies that the final rule will not
have a significant economic impact on ■ 1. The authority citation for 21 CFR
These mechanisms assist FDA in
a substantial number of small entities. part 601 continues to read as follows:
evaluating and monitoring the safety
and effectiveness of biological products. The Unfunded Mandates Reform Act Authority: 15 U.S.C. 1451–1561; 21 U.S.C.
of 1995 (section 202(a)) requires us to 321, 351, 352, 353, 355, 356b, 360, 360c–
C. Summary of Comments to the prepare a written statement, which 360f, 360h-360j, 371, 374, 379e, 381; 42
Proposed Rule includes an assessment of anticipated U.S.C. 216, 241, 262, 263, 264; sec 122,
Pub. L. 105–115, 111 Stat. 2322 (21 U.S.C.
FDA did not receive any comments on costs and benefits, before issuing ‘‘any
355 note).
the proposed rule. rule that includes any Federal mandate
that may result in the expenditure by § 601.25 [Removed]
D. General Overview of the Final Rule State, local, and tribal governments, in ■ 2. Remove § 601.25.
The final rule removes §§ 601.25 and the aggregate, or by the private sector, of
601.26 of the regulations, which $100,000,000 or more (adjusted § 601.26 [Removed]
prescribe procedures for FDA’s review annually for inflation) in any one year.’’ ■ 3. Remove § 601.26.
and classification of biological products The current threshold after adjustment
Dated: February 5, 2016.
licensed before July 1, 1972. FDA is for inflation is $144 million, using the
most current (2014) Implicit Price Leslie Kux,
taking this action because these
Deflator for the Gross Domestic Product. Associate Commissioner for Policy.
regulations are obsolete and no longer
This final rule would not result in any [FR Doc. 2016–02884 Filed 2–11–16; 8:45 am]
necessary in light of other statutory and
regulatory authorities established since 1-year expenditure that would meet or BILLING CODE 4164–01–P
1972, which allow FDA to evaluate and exceed this amount.
monitor the safety and effectiveness of V. Analysis of Environmental Impact DEPARTMENT OF HEALTH AND
all biological products.
We have determined under 21 CFR HUMAN SERVICES
III. Legal Authority 25.30(h) that this action is of a type that
does not individually or cumulatively Food and Drug Administration
FDA is issuing this regulation under
the biological products provisions of the have a significant adverse effect on the
human environment. Therefore, neither 21 CFR Parts 868 and 870
PHS Act (42 U.S.C. 262 and 264) and
the drugs and general administrative an environmental assessment nor an [Docket No. FDA–2012–N–1174]
provisions of the FD&C Act (sections environmental impact statement is
201, 301, 501, 502, 503, 505, 510, 701, required. Anesthesiology Devices;
Reclassification of Membrane Lung for
and 704 (21 U.S.C. 321, 331, 351, 352, VI. Paperwork Reduction Act of 1995
Long-Term Pulmonary Support;
353, 355, 360, 371, and 374)). Under This final rule contains no collection Redesignation as Extracorporeal
these provisions of the PHS Act and the of information. Therefore, clearance by Circuit and Accessories for Long-Term
FD&C Act, we have the authority to OMB under the Paperwork Reduction Respiratory/Cardiopulmonary Failure
issue and enforce regulations designed Act of 1995 is not required.
to ensure that biological products are AGENCY: Food and Drug Administration,
safe, pure, and potent; and to prevent VII. Federalism HHS.
the introduction, transmission, and We have analyzed this final rule in ACTION: Final order.
spread of communicable disease. accordance with the principles set forth
in Executive Order 13132. FDA has SUMMARY: The Food and Drug
IV. Economic Analysis of Impacts
determined that the rule does not Administration (FDA) is issuing a final
We have examined the impacts of the contain policies that would have order to redesignate membrane lung
final rule under Executive Order 12866, substantial direct effects on the States, devices for long-term pulmonary
Executive Order 13563, the Regulatory on the relationship between the support, a preamendments class III
Flexibility Act (5 U.S.C. 601–612), and National Government and the States, or device, as extracorporeal circuit and
the Unfunded Mandates Reform Act of on the distribution of power and accessories for long-term respiratory/
1995 (Pub. L. 104–4). Executive Orders responsibilities among the various cardiopulmonary failure, and to
12866 and 13563 direct Agencies to levels of government. Accordingly, the reclassify the device to class II (special
assess all costs and benefits of available Agency has concluded that the rule does controls) in patients with acute
regulatory alternatives and, when not contain policies that have respiratory failure or acute
regulation is necessary, to select federalism implications as defined in cardiopulmonary failure where other
regulatory approaches that maximize the Executive order and, consequently, available treatment options have failed,
srobinson on DSK5SPTVN1PROD with RULES
net benefits (including potential a federalism summary impact statement and continued clinical deterioration is
economic, environmental, public health is not required. expected or the risk of death is
and safety, and other advantages; imminent. A membrane lung device for
distributive impacts; and equity). We List of Subjects in 21 CFR Part 601 long-term pulmonary support (>6 hours)
believe that this final rule is not a Administrative practice and refers to the oxygenator in an
significant regulatory action as defined procedure, Biologics, Confidential extracorporeal circuit used during long-
by Executive Order 12866. business information. term procedures, commonly referred to
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![Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 7451
about to be significantly changed or or acute cardiopulmonary failure, where deterioration is expected or the risk of
modified, manufacturers must obtain other available treatment options have death is imminent into class II (special
510(k) clearance, among other relevant failed, and continued clinical controls).
requirements, and demonstrate deterioration is expected or the risk of
IX. References
compliance with the special controls death is imminent, and, therefore, this
included in the final order, before device type is not exempt from The following references are on
marketing the new or changed device. premarket notification requirements. display in the Division of Dockets
V. The Final Order VI. Analysis of Environmental Impact Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
Under section 513(e) of the FD&C Act, The Agency has determined under 21
1061, Rockville, MD 20852, and are
FDA is adopting its findings as CFR 25.34(b) that this action is of a type
available for viewing by interested
published in the preamble to the that does not individually or
persons between 9 a.m. and 4 p.m.,
proposed order (78 FR 1158) with cumulatively have a significant effect on
Monday through Friday; they are also
modifications as discussed in section IV the human environment. Therefore,
available electronically at http://
of this final order. FDA is issuing this neither an environmental assessment
www.regulations.gov. FDA has verified
final order to reclassify the membrane nor an environmental impact statement
lung devices for long-term pulmonary is required. the Web site addresses, as of the date
support from class III to class II for use this document publishes in the Federal
VII. Paperwork Reduction Act of 1995 Register, but Web sites are subject to
in patients with acute respiratory failure
or acute cardiopulmonary failure, where This final order refers to previously change over time.
other available treatment options have approved collections of information 1. The panel transcript and other meeting
failed and continued clinical found in FDA regulations. These materials for the September 12, 2013,
deterioration is expected or the risk of collections of information are subject to Circulatory System Devices Panel are
death is imminent, and to establish review by the Office of Management and available on FDA’s Web site at http://
Budget (OMB) under the Paperwork www.fda.gov/AdvisoryCommittees/
special controls. FDA is removing the
Reduction Act of 1995 (44 U.S.C. 3501– CommitteesMeetingMaterials/Medical
regulation from 21 CFR part 868 Devices/MedicalDevicesAdvisory
(Anesthesiology Devices) and adding it 3520). The collections of information in
Committee/CirculatorySystemDevices
to 21 CFR part 870 (Cardiovascular 21 CFR part 812 have been approved Panel/ucm342357.htm.
Devices) to better align this device type under OMB control number 0910–0078; 2. The panel transcript and other meeting
(and the review thereof) with other the collections of information in 21 CFR materials for the May 7, 2014,
similar types of cardiovascular devices. part 807, subpart E, have been approved Circulatory System Devices Panel are
The title and identification of under OMB control number 0910–0120; available on FDA’s Web site at. http://
§ 870.4100 (21 CFR 870.4100) reflects the collections of information in 21 CFR www.fda.gov/AdvisoryCommittees/
the Agency’s intent to regulate ECMO part 814, subpart B, have been approved CommitteesMeetingMaterials/Medical
under OMB control number 0910–0231; Devices/MedicalDevicesAdvisory
and the accessories used in ECMO
Committee/CirculatorySystemDevices
under the same set of regulatory and the collections of information under
Panel/ucm395638.htm
controls. However, an individual device 21 CFR part 801 have been approved
or accessory in an ECMO circuit may under OMB control number 0910–0485. List of Subjects in 21 CFR Parts 868 and
already have its own classification VIII. Codification of Orders 870
regulation when intended for short-term
use (≤6 hours) and, in those instances, Prior to the amendments by FDASIA, Medical devices.
such device or accessory is subject to section 513(e) of the FD&C Act provided
for FDA to issue regulations to reclassify Therefore, under the Federal Food,
the preexisting regulation(s).
Following the effective date of this devices. Although section 513(e) of the Drug, and Cosmetic Act and under
final order, firms marketing membrane FD&C Act as amended requires FDA to authority delegated to the Commissioner
lung devices for long-term pulmonary issue final orders rather than of Food and Drugs, 21 CFR parts 868
support for use in patients with acute regulations, FDASIA also provides for and 870 are amended as follows:
respiratory failure or acute FDA to revoke previously issued
PART 868—ANESTHESIOLOGY
cardiopulmonary failure, where other regulations by order. FDA will continue
DEVICES
available treatment options have failed to codify classifications and
and continued clinical deterioration is reclassifications in the Code of Federal
expected or the risk of death is Regulations (CFR). Changes resulting ■ 1. The authority citation for 21 CFR
imminent, must comply with the from final orders will appear in the CFR part 868 continues to read as follows:
particular mitigation measures set forth as changes to codified classification Authority: 21 U.S.C. 351, 360, 360c, 360e,
in the special controls. determinations or as newly codified 360j, 371.
Section 510(m) of the FD&C Act orders. Therefore, under section § 868.5610 [Removed]
provides that FDA may exempt a class 513(e)(1)(A)(i) of the FD&C Act, as
II device from the premarket notification amended by FDASIA, in this final order, ■ 2. Remove § 868.5610.
requirements under section 510(k) of the we are revoking the requirements in 21
FD&C Act if FDA determines that CFR 868.5610 related to the PART 870—CARDIOVASCULAR
premarket notification is not necessary classification of membrane lung for DEVICES
to provide reasonable assurance of the long-term pulmonary support as class III
srobinson on DSK5SPTVN1PROD with RULES
safety and effectiveness of the devices. devices and codifying under § 870.4100 ■ 1. The authority citation for 21 CFR
FDA has determined that premarket the reclassification of membrane lung part 870 continues to read as follows:
notification is necessary to provide for long-term pulmonary support for use Authority: 21 U.S.C. 351, 360, 360c, 360e,
reasonable assurance of safety and in patients with acute respiratory failure 360j, 371.
effectiveness of membrane lung devices or acute cardiopulmonary failure, where
for long-term pulmonary support for use other available treatment options have ■ 2. Add § 870.4100 to subpart E to read
in patients with acute respiratory failure failed, and continued clinical as follows:
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![7452 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations
§ 870.4100 Extracorporeal circuit and and accessories in the circuit, and into class I or II, or FDA issues an order
accessories for long-term respiratory/ maintenance during a procedure. finding the device to be substantially
cardiopulmonary failure. equivalent, in accordance with section
Dated: February 8, 2016.
(a) Identification. An extracorporeal 513(i) of the FD&C Act, to a predicate
circuit and accessories for long-term Leslie Kux,
device that does not require premarket
respiratory/cardiopulmonary support Associate Commissioner for Policy.
approval. The Agency determines
(>6 hours) is a system of devices and [FR Doc. 2016–02876 Filed 2–11–16; 8:45 am] whether new devices are substantially
accessories that provides assisted BILLING CODE 4164–01–P equivalent to predicate devices by
extracorporeal circulation and means of premarket notification
physiologic gas exchange of the procedures in section 510(k) of the
patient’s blood in patients with acute DEPARTMENT OF HEALTH AND FD&C Act (21 U.S.C. 360(k)) and part
respiratory failure or acute HUMAN SERVICES 807 (21 CFR part 807) of the regulations.
cardiopulmonary failure, where other Section 513(f)(2) of the FD&C Act, as
available treatment options have failed, Food and Drug Administration
amended by section 607 of the Food and
and continued clinical deterioration is Drug Administration Safety and
expected or the risk of death is 21 CFR Part 878 Innovation Act (Pub. L. 112–144),
imminent. The main devices and [Docket No. FDA–2016–N–0237] provides two procedures by which a
accessories of the system include, but person may request FDA to classify a
are not limited to, the console Medical Devices; General and Plastic device under the criteria set forth in
(hardware), software, and disposables, Surgery Devices; Classification of the section 513(a)(1) of the FD&C Act.
including, but not limited to, an Scalp Cooling System To Reduce the Under the first procedure, the person
oxygenator, blood pump, heat Likelihood of Chemotherapy-Induced submits a premarket notification under
exchanger, cannulae, tubing, filters, and Alopecia section 510(k) of the FD&C Act for a
other accessories (e.g., monitors, AGENCY: Food and Drug Administration, device that has not previously been
detectors, sensors, connectors). HHS. classified and, within 30 days of
(b) Classification—Class II (special receiving an order classifying the device
controls). The special controls for this ACTION: Final order. into class III under section 513(f)(1) of
device are: SUMMARY: The Food and Drug the FD&C Act, the person requests a
(1) The technological characteristics Administration (FDA) is classifying the classification under section 513(f)(2).
of the device must ensure that the scalp cooling system to reduce the Under the second procedure, rather than
geometry and design parameters are likelihood of chemotherapy-induced first submitting a premarket notification
consistent with the intended use, and alopecia into class II (special controls). under section 510(k) of the FD&C Act
that the devices and accessories in the The special controls that will apply to and then a request for classification
circuit are compatible; the device are identified in this order under the first procedure, the person
(2) The devices and accessories in the and will be part of the codified language determines that there is no legally
circuit must be demonstrated to be for the scalp cooling system to reduce marketed device upon which to base a
biocompatible; the likelihood of chemotherapy-induced determination of substantial
(3) Sterility and shelf-life testing must equivalence and requests a classification
alopecia’s classification. The Agency is
demonstrate the sterility of any patient- under section 513(f)(2) of the FD&C Act.
classifying the device into class II
contacting devices and accessories in If the person submits a request to
(special controls) in order to provide a
the circuit and the shelf life of these classify the device under this second
reasonable assurance of safety and
devices and accessories; procedure, FDA may decline to
(4) Non-clinical performance effectiveness of the device.
undertake the classification request if
evaluation of the devices and DATES: This order is effective February
FDA identifies a legally marketed device
accessories in the circuit must 12, 2016. The classification was that could provide a reasonable basis for
demonstrate substantial equivalence of applicable on December 8, 2015. review of substantial equivalence with
the performance characteristics on the FOR FURTHER INFORMATION CONTACT: Neil the device or if FDA determines that the
bench, mechanical integrity, Ogden, Center for Devices and device submitted is not of ‘‘low-
electromagnetic compatibility (where Radiological Health, Food and Drug moderate risk’’ or that general controls
applicable), software, durability, and Administration, 10903 New Hampshire would be inadequate to control the risks
reliability; Ave., Bldg. 66, Rm. G414, Silver Spring, and special controls to mitigate the risks
(5) In vivo evaluation of the devices MD 20993–0002, 301–796–6397. cannot be developed.
and accessories in the circuit must SUPPLEMENTARY INFORMATION: In response to a request to classify a
demonstrate their performance over the device under either procedure provided
intended duration of use, including a I. Background
by section 513(f)(2) of the FD&C Act,
detailed summary of the clinical In accordance with section 513(f)(1) of FDA will classify the device by written
evaluation pertinent to the use of the the Federal Food, Drug, and Cosmetic order within 120 days. This
devices and accessories to demonstrate Act (the FD&C Act) (21 U.S.C. classification will be the initial
their effectiveness if a specific 360c(f)(1)), devices that were not in classification of the device.
indication (patient population and/or commercial distribution before May 28, On March 6, 2015, Target Health, Inc.
condition) is identified; and 1976 (the date of enactment of the (on behalf of Dignitana AB) submitted a
(6) Labeling must include a detailed Medical Device Amendments of 1976), request for classification of the
srobinson on DSK5SPTVN1PROD with RULES
summary of the non-clinical and in vivo generally referred to as postamendments DigniCapTM Scalp Cooling System
evaluations pertinent to use of the devices, are classified automatically by under section 513(f)(2) of the FD&C Act.
devices and accessories in the circuit statute into class III without any FDA The manufacturer recommended that
and adequate instructions with respect rulemaking process. These devices the device be classified into class II (Ref.
to anticoagulation, circuit setup, remain in class III and require 1).
performance characteristics with respect premarket approval, unless and until In accordance with section 513(f)(2) of
to compatibility among different devices the device is classified or reclassified the FD&C Act, FDA reviewed the
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Document Created: 2016-02-12 01:24:12
Document Modified: 2016-02-12 01:24:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective February 12, 2016. | |
| Contact | Fernando Aguel, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1234, Silver Spring, MD 20993, 301-796-6326, [email protected] | |
| FR Citation | 81 FR 7446 | |
| CFR Citation | 21
CFR
868 21 CFR 870 |
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