83 FR 19626 - General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 87 (May 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 87 (May 4, 2018)
| Page Range | 19626-19628 | |
| FR Document | 2018-09434 |
[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)] [Rules and Regulations] [Pages 19626-19628] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-09434] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 880 [Docket No. FDA-2017-N-6216] General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify the needle destruction device, renaming the device to ``sharps needle destruction device,'' a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device. This order reclassifies these types of devices from class III to class II and will reduce regulatory burdens on industry because these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a less burdensome premarket notification (510(k)) before marketing their device. DATES: This order is effective June 4, 2018. FOR FURTHER INFORMATION CONTACT: Christopher K. Dugard, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2561, Silver Spring, MD 20993, 240- 402-6031, christopher.dugard@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes 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). 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)(1) 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 postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or class II under section 513(f)(3). Section 513(f)(3) of the FD&C Act provides that FDA acting by order can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. 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 regulatory authority (see Bell [[Page 19627]] v. Goddard, 366 F.2d 177, 181 (7th Cir. 1966); Ethicon, Inc. v. FDA, 762 F. Supp. 382, 388-391 (D.D.C. 1991)) or in light of changes in ``medical science'' (Upjohn v. Finch, 422 F.2d 944, 951 (6th Cir. 1970)). Whether data before the Agency are old or new, the ``new information'' to support reclassification under 513(f)(3) 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 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 520(h)(4) of the FD&C Act provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved. This includes information from clinical and preclinical tests or studies that demonstrate the safety or effectiveness of the device, but does not include descriptions of methods of manufacture or product composition and other trade secrets. Section 510(m) of the FD&C Act provides that a class II device may be exempted from the 510(k) premarket notification requirements, if the Agency determines that premarket notification is not necessary to reasonably assure the safety and effectiveness of the device. On November 7, 2017, FDA published an order in the Federal Register to reclassify the device (82 FR 51585) (the ``proposed order''). The period for public comment on the proposed order closed on January 8, 2018. FDA received and has considered two comments on the proposed order, as discussed in section II. II. Comments on the Proposed Order and FDA Response A. Introduction We received two comments on the proposed order and both comments supported the proposed reclassification. The comments were received from a consumer and a healthcare professional in the drug industry. We describe and respond to the comments in section B of this section. The order of response to the commenters is purely for organizational purposes and does not signify the comment's value or importance nor the order in which comments were received. B. Description of Comments and FDA Response (Comment 1) One commenter discussed the experience of witnessing sharps disposal and was supportive of safe and cost-effective options for sharps disposal due to the potential injury to sanitation works or patients/users with improper disposal of sharps. The commenter was generally supportive of FDA's proposed reclassification. Additionally, the commenter stated that PMA requirements increase the price of these devices and that reclassification increases affordability of the sharps needle destruction devices, while ensuring safety. (Response 1) FDA agrees with this comment. The Agency believes that reclassification of the sharps needle destruction device will reduce the regulatory burden on manufacturers, which could increase patient access to these devices and potentially reduce accidental needle sticks, while still providing reasonable assurance of safety and effectiveness. Additionally, FDA believes the special controls mitigate workplace hazards associated with sharps needle destruction and ensures proper use of the device. (Comment 2) One commenter noted that while a PMA for these devices will no longer be required, FDA will still require premarket notification under section 510(k) of the FD&C Act. The commenter stated that in addition to 510(k) requirements, a prescription use restriction, and labeling, the identified special controls will provide reasonable assurance of device safety and effectiveness. The commenter noted that PMAs delay the access of these devices to patients. The commenter concluded that this reclassification may factor in positive outcomes for patient access and safety. (Response 2) FDA agrees with this comment. The Agency believes that the special controls required in this final order provide a reasonable assurance of safety and effectiveness for these devices. FDA believes it has identified the risks to health (see section V of the proposed order) and that the measures described in this final order will be effective in mitigating the identified probable risks to health. Additionally, by reclassifying these types of devices from class III to class II, this will reduce regulatory burdens on industry because these types of devices will no longer be required to submit a PMA, but can instead submit a less burdensome premarket notification (510(k)) before marketing their device. III. The Final Order FDA is adopting its findings under section 513(f)(3) of the FD&C Act, as published in the preamble to the proposed order. FDA is issuing this final order to reclassify needle destruction devices from class III to class II, rename them sharps needle destruction devices, and establish special controls by revising 21 CFR part 880. In this final order, the Agency has identified the special controls under section 513(a)(1)(B) of the FD&C Act that, together with general controls, provide a reasonable assurance of the safety and effectiveness for sharps needle destruction devices. FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act under section 510(m) 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 sharps needle destruction devices, and therefore, this device type is not exempt from premarket notification requirements. The device is assigned the generic name sharps needle destruction device, and it is identified as a prescription device that is intended to destroy needles or sharps used for medical purposes by incineration or mechanical means. Under this final order, the sharps needle destruction device is a prescription use device under Sec. 801.109 (21 CFR 801.109). Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of Sec. 801.109 are met (referring to 21 U.S.C. 352(f)(1)). Under 21 CFR 807.81, the device would continue to be subject to 510(k) requirements. IV. Analysis of Environmental Impact We have 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. [[Page 19628]] V. Paperwork Reduction Act of 1995 This final administrative order establishes special controls that refer to previously approved collections of information found in other 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 part 807, subpart E have been approved under OMB control number 0910-0120 and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 880 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq., as amended) and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 880 is amended as follows: PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES 0 1. The authority citation for part 880 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 880.6210 to subpart G to read as follows: Sec. 880.6210 Sharps needle destruction device. (a) Identification. A sharps needle destruction device is a prescription device that is intended to destroy needles or sharps used for medical purposes by incineration or mechanical means. (b) Classification. Class II (special controls). The special controls for this device are: (1) Performance testing must demonstrate the following during operation of the device: (i) The device safely contains or ventilates aerosols or fumes from device operation. (ii) Excessive heat or sparks are not generated that may injure users or patients. (iii) Simulated use testing must demonstrate sharps and/or needles are completely destroyed using a range of types and sizes of sharps sufficient to represent actual use. (iv) Simulated use testing must demonstrate that the device is physically stable on the surface for which it is intended to be mounted to ensure the risk of harm to the patient/user as a result of the device falling is minimized. (2) Validation of cleaning and disinfection instructions must demonstrate that the device can be safely and effectively reprocessed after use per the recommended cleaning and disinfection protocol in the instructions for use. (3) Analysis and/or testing must validate electromagnetic compatibility and electrical safety, including the safety of any battery used in the device, under conditions which are consistent with the intended environment of device use. (4) Software verification, validation, and hazard analysis must be performed. (5) Labeling must include: (i) A clear description of the device and its technological features; (ii) How the device is to be used, including validated cleaning and disinfection instructions; (iii) Relevant precautions and warnings based on performance and in-use testing to ensure proper use of the device; and (iv) Instructions to install device in adequately ventilated area and stable area. Dated: April 30, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-09434 Filed 5-3-18; 8:45 am] BILLING CODE 4164-01-P
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conflicts with the exercise of Federal Beneficial Physiological Effects of DATES: This order is effective June 4,
authority under the Federal statute.’’ Isolated or Synthetic Non-Digestible 2018.
Section 403A of the FD&C Act (21 Carbohydrates Submitted as a Citizen
Petition; Guidance for Industry; FOR FURTHER INFORMATION CONTACT:
U.S.C. 343–1) is an express preemption Christopher K. Dugard, Center for
Availability. ’’ 83 FR 8997 (March 2,
provision. Section 403A(a) of the FD&C 2018). Guidance available at https:// Devices and Radiological Health, Food
Act provides that: ‘‘. . . no State or www.fda.gov/Food/GuidanceRegulation/ and Drug Administration, 10903 New
political subdivision of a State may GuidanceDocumentsRegulatory Hampshire Ave., Bldg. 66, Rm. 2561,
directly or indirectly establish under Information/ucm528532.htm. Silver Spring, MD 20993, 240–402–
any authority or continue in effect as to 5. Food and Drug Administration, ‘‘The 6031, christopher.dugard@fda.hhs.gov.
any food in interstate commerce—(4) Declaration of Added Sugars on Honey,
Maple Syrup, and Certain Cranberry SUPPLEMENTARY INFORMATION:
any requirement for nutrition labeling of
food that is not identical to the Products; Draft Guidance for Industry; I. Background
requirement of section 403(q) . . . .’’ Availability.’’ 83 FR 8953 (March 2,
2018). Guidance available at https:// The Federal Food, Drug, and Cosmetic
The express preemption provision of www.fda.gov/Food/GuidanceRegulation/ Act (FD&C Act), as amended, establishes
section 403A(a) of the FD&C Act does GuidanceDocumentsRegulatory a comprehensive system for the
not preempt any State or local Information/ucm595578.htm. regulation of medical devices intended
requirement respecting a statement in for human use. Section 513 of the FD&C
Dated: April 30, 2018.
the labeling of food that provides for a Act (21 U.S.C. 360c) established three
warning concerning the safety of the Leslie Kux,
Associate Commissioner for Policy. categories (classes) of devices, reflecting
food or component of the food (section the regulatory controls needed to
6(c)(2) of the Nutrition Labeling and [FR Doc. 2018–09476 Filed 5–3–18; 8:45 am]
provide reasonable assurance of their
Education Act of 1990, Pub. L. 101–535, BILLING CODE 4164–01–P2
safety and effectiveness. The three
104 Stat. 2353, 2364 (1990)). The final categories of devices are class I (general
rule creates requirements that fall controls), class II (special controls), and
within the scope of section 403A(a) of DEPARTMENT OF HEALTH AND
HUMAN SERVICES class III (premarket approval).
the FD&C Act. Devices that were not in commercial
IX. References Food and Drug Administration distribution prior to May 28, 1976
(generally referred to as
The following references are on postamendments devices) are
display in the Dockets Management 21 CFR Part 880
automatically classified by section
Staff (see ADDRESSES) and are available 513(f)(1) of the FD&C Act into class III
for viewing by interested persons [Docket No. FDA–2017–N–6216]
without any FDA rulemaking process.
between 9 a.m. and 4 p.m., Monday Those devices remain in class III and
through Friday; they are also available General Hospital and Personal Use
Devices; Reclassification of Sharps require premarket approval unless, and
electronically at https:// until, the device is reclassified into class
www.regulations.gov. FDA has verified Needle Destruction Device
I or II, or FDA issues an order finding
the website addresses, as of the date this AGENCY: Food and Drug Administration, the device to be substantially
document publishes in the Federal HHS. equivalent, in accordance with section
Register, but websites are subject to 513(i) of the FD&C Act, to a predicate
ACTION: Final order.
change over time. device that does not require premarket
1. FDA. Final Regulatory Impact Analysis, SUMMARY: The Food and Drug approval. The Agency determines
Regulatory Flexibility Analysis for Final Administration (FDA or the Agency) is whether new devices are substantially
Rule on ‘‘Food Labeling: Revision of the issuing a final order to reclassify the equivalent to predicate devices by
Nutrition and Supplement Facts Labels needle destruction device, renaming the means of premarket notification
and Serving Sizes of Foods That Can device to ‘‘sharps needle destruction
Reasonably Be Consumed At One Eating
procedures in section 510(k) of the
Occasion; Dual-Column Labeling;
device,’’ a postamendments class III FD&C Act (21 U.S.C. 360(k)) and part
Updating, Modifying, and Establishing device (regulated under product code 807 (21 CFR part 807).
Certain Reference Amounts Customarily MTV), into class II (special controls), A postamendments device that has
Consumed; Serving Size for Breath subject to premarket notification. FDA is been initially classified in class III
Mints; and Technical Amendments; also identifying the special controls that under section 513(f)(1) of the FD&C Act
Extension of Compliance Dates.’’ April the Agency believes are necessary to may be reclassified into class I or class
2018. Available from https://www.fda. provide a reasonable assurance of safety II under section 513(f)(3). Section
gov/AboutFDA/ReportsManualsForms/ and effectiveness of the device. FDA is 513(f)(3) of the FD&C Act provides that
Reports/EconomicAnalyses. finalizing this reclassification on its FDA acting by order can reclassify the
2. Sheahan, M. ‘‘FDA Blog Post.’’ Label
Insight. April 5, 2018. Available at
own initiative based on new device into class I or class II on its own
https://blog.labelinsight.com/growing- information. The Agency is classifying initiative, or in response to a petition
new-label-adoption-provides- the device into class II (special controls) from the manufacturer or importer of
transparency-for-consumers. to provide a reasonable assurance of the device. To change the classification
3. Food and Drug Administration, ‘‘Reference safety and effectiveness of the device. of the device, the proposed new class
Amounts Customarily Consumed: List of This order reclassifies these types of must have sufficient regulatory controls
Products for Each Product Category; devices from class III to class II and will to provide reasonable assurance of the
Guidance for Industry; Availability.’’ 83 reduce regulatory burdens on industry safety and effectiveness of the device for
amozie on DSK3GDR082PROD with RULES
FR 9000 (March 2, 2018). Guidance because these types of devices will no its intended use.
available at https://www.fda.gov/Food/
GuidanceRegulation/Guidance
longer be required to submit a Reevaluation of the data previously
DocumentsRegulatoryInformation/ premarket approval application (PMA), before the Agency is an appropriate
ucm535368.htm. but can instead submit a less basis for subsequent action where the
4. Food and Drug Administration, ‘‘Scientific burdensome premarket notification reevaluation is made in light of newly
Evaluation of the Evidence on the (510(k)) before marketing their device. available regulatory authority (see Bell
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V. Paperwork Reduction Act of 1995 (2) Validation of cleaning and Lauderdale Air Show. This special local
This final administrative order disinfection instructions must regulation prohibits persons and non-
establishes special controls that refer to demonstrate that the device can be participant vessels from entering,
previously approved collections of safely and effectively reprocessed after transiting through, anchoring in, or
information found in other FDA use per the recommended cleaning and remaining within the regulated area
regulations. These collections of disinfection protocol in the instructions unless authorized by the Captain of the
information are subject to review by the for use. Port Miami or a designated
Office of Management and Budget (3) Analysis and/or testing must representative.
(OMB) under the Paperwork Reduction validate electromagnetic compatibility DATES: This rule is effective May 4,
Act of 1995 (44 U.S.C. 3501–3520). The and electrical safety, including the 2018.
collections of information in part 807, safety of any battery used in the device,
under conditions which are consistent ADDRESSES: To view documents
subpart E have been approved under mentioned in this preamble as being
OMB control number 0910–0120 and with the intended environment of
device use. available in the docket, go to http://
the collections of information under 21 www.regulations.gov, type USCG–2017–
CFR part 801 have been approved under (4) Software verification, validation,
and hazard analysis must be performed. 0993 in the ‘‘SEARCH’’ box and click
OMB control number 0910–0485. ‘‘SEARCH.’’ Click on Open Docket
(5) Labeling must include:
List of Subjects in 21 CFR Part 880 (i) A clear description of the device Folder on the line associated with this
and its technological features; rule.
Medical devices.
(ii) How the device is to be used, FOR FURTHER INFORMATION CONTACT: If
Therefore, under the Federal Food, you have questions on this rule, call or
Drug, and Cosmetic Act (21 U.S.C. 321 including validated cleaning and
disinfection instructions; email Petty Officer Mara J. Brown,
et seq., as amended) and under Sector Miami Waterways Management
authority delegated to the Commissioner (iii) Relevant precautions and
warnings based on performance and in- Division, U.S. Coast Guard; telephone
of Food and Drugs, 21 CFR part 880 is 305–535–4317, email Mara.J.Brown@
amended as follows: use testing to ensure proper use of the
device; and uscg.mil.
PART 880—GENERAL HOSPITAL AND (iv) Instructions to install device in SUPPLEMENTARY INFORMATION:
PERSONAL USE DEVICES adequately ventilated area and stable
area. I. Table of Abbreviations
■ 1. The authority citation for part 880 Dated: April 30, 2018. CFR Code of Federal Regulations
continues to read as follows: DHS Department of Homeland Security
Leslie Kux,
FR Federal Register
Authority: 21 U.S.C. 351, 360, 360c, 360e, Associate Commissioner for Policy. NPRM Notice of proposed rulemaking
360j, 360l, 371.
[FR Doc. 2018–09434 Filed 5–3–18; 8:45 am] § Section
■ 2. Add § 880.6210 to subpart G to read BILLING CODE 4164–01–P U.S.C. United States Code
as follows: II. Background Information and
§ 880.6210 Sharps needle destruction Regulatory History
device. DEPARTMENT OF HOMELAND The City of Fort Lauderdale notified
SECURITY the Coast Guard that it would be hosting
(a) Identification. A sharps needle
destruction device is a prescription Coast Guard the Fort Lauderdale Air Show annually
device that is intended to destroy over a Saturday and Sunday during the
needles or sharps used for medical 33 CFR Part 100 month of May. The regulated area
purposes by incineration or mechanical would cover certain navigable waters of
means. [Docket Number USCG–2017–0993] the Atlantic Ocean east of Fort
(b) Classification. Class II (special Lauderdale, Florida beginning at Port
RIN 1625–AA08
controls). The special controls for this Everglades Inlet and continuing north
device are: Special Local Regulation: Fort for approximately six miles.
(1) Performance testing must Lauderdale Air Show; Atlantic Ocean, In response, on January 25, 2018, the
demonstrate the following during Fort Lauderdale, FL Coast Guard published a notice of
operation of the device: proposed rulemaking (NPRM) titled
(i) The device safely contains or AGENCY: Coast Guard, DHS. ‘‘Special Local Regulation: Fort
ventilates aerosols or fumes from device ACTION: Final rule. Lauderdale Air Show; Atlantic Ocean,
operation. Fort Lauderdale, FL’’ (83 FR 3450).
(ii) Excessive heat or sparks are not SUMMARY: The Coast Guard is There we stated why we issued the
generated that may injure users or establishing a recurring special local NPRM, and invited comments on our
patients. regulation for certain navigable waters proposed regulatory action related to
(iii) Simulated use testing must of the Atlantic Ocean east of Fort this event. During the comment period
demonstrate sharps and/or needles are Lauderdale, Florida beginning at the that ended February 26, 2018, we
completely destroyed using a range of Port Everglades Inlet and extending received 2 unrelated comments.
types and sizes of sharps sufficient to north approximately six miles. The Under 5 U.S.C. 553(d)(3), the Coast
represent actual use. special local regulation is necessary to Guard finds that good cause exists for
(iv) Simulated use testing must ensure the safety of the public, making this rule effective less than 30
amozie on DSK3GDR082PROD with RULES
demonstrate that the device is spectators, vessels, and the marine days after publication in the Federal
physically stable on the surface for environment during aerobatic Register. Delaying the effective date of
which it is intended to be mounted to maneuvers conducted by high-speed, this rule would be impracticable
ensure the risk of harm to the patient/ low-flying airplanes and high speed because immediate action is needed to
user as a result of the device falling is vessels performing inside of the respond to the potential safety dangers
minimized. regulated area during the Fort with aerial maneuvers conducted by
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Document Created: 2018-11-02 09:53:06
Document Modified: 2018-11-02 09:53:06
| 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 June 4, 2018. | |
| Contact | Christopher K. Dugard, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2561, Silver Spring, MD 20993, 240- 402-6031, [email protected] | |
| FR Citation | 83 FR 19626 |
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