82 FR 35065 - Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 144 (July 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 144 (July 28, 2017)
| Page Range | 35065-35067 | |
| FR Document | 2017-15901 |
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)] [Rules and Regulations] [Pages 35065-35067] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15901] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2017-N-1620] Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the adjunctive cardiovascular status indicator into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the adjunctive cardiovascular status indicator's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective July 28, 2017. The classification was applicable on December 21, 2016. FOR FURTHER INFORMATION CONTACT: Nathalie Yarkony, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993-0002, 301- 796-1235, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval unless and until the device is classified or 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) of the regulations. [[Page 35066]] Section 513(f)(2) of the FD&C Act, also known as De Novo classification, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On May 24, 2016, Flashback Technologies submitted a request for classification of the CipherOx CRI Tablet under section 513(f)(2) of the FD&C Act. In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on December 21, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding Sec. 870.2200. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an adjunctive cardiovascular status indicator will need to comply with the special controls named in this final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or premarket approval application in order to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome 510(k) pathway, when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers. The device is assigned the generic name adjunctive cardiovascular status indicator, and it is identified as a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1: Table 1--Adjunctive Cardiovascular Status Indicator Risks and Mitigation Measures ---------------------------------------------------------------------------------------------------------------- Identified risk Mitigation measures ---------------------------------------------------------------------------------------------------------------- Delayed or incorrect treatment due Software verification, validation, and hazard analysis. to erroneous output as a result of Non-clinical performance testing. software malfunction or algorithm Clinical performance testing. error. Labeling. Delayed or incorrect treatment due Usability assessment. to user misinterpretation. Labeling. ---------------------------------------------------------------------------------------------------------------- FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. Adjunctive cardiovascular status indicators are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109 Prescription devices). 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), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA believes premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, is planning to exempt the device from the premarket notification requirements under section 510(m) of the FD&C Act. Once finalized, persons who intend to market this device type need not submit a 510(k) premarket notification containing information on the adjunctive cardiovascular status indicator prior to marketing the device. II. 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. III. Paperwork Reduction Act of 1995 This final administrative order establishes special controls that refer to previously approved collections of [[Page 35067]] 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, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 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 part 870 is amended as follows: PART 870--CARDIOVASCULAR DEVICES 0 1. The authority citation for part 870 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 870.2200 to subpart C to read as follows: Sec. 870.2200 Adjunctive cardiovascular status indicator. (a) Identification. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. (b) Classification. Class II (special controls). The special controls for this device are: (1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including: (i) Full characterization of technical parameters of the software, including any proprietary algorithm(s); (ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications; (iii) Specification of acceptable incoming sensor data quality control measures; and (iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports. (2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling. (3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated. (4) Clinical data must be provided in support of the intended use and include the following: (i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner; (ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified; (iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and (iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment. (5) Labeling must include the following: (i) The type of sensor data used, including specification of compatible sensors for data acquisition; (ii) A description of what the device measures and outputs to the user; (iii) Warnings identifying sensor reading acquisition factors that may impact measurement results; (iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements; (v) Key assumptions made in the calculation and determination of measurements; (vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and (vii) A detailed description of the patients studied in the clinical validation (e.g., age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study. Dated: July 24, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-15901 Filed 7-27-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Rules and Regulations 35065
Department of Commerce revised its List of Subjects DEPARTMENT OF HEALTH AND
regulations on antidumping and HUMAN SERVICES
19 CFR Part 159
countervailing duty proceedings to
conform to the Uruguay Round Alcohol and alcohol beverages, Food and Drug Administration
Agreements Act (62 FR 27296) (May 19, Antidumping (Liquidation of duties),
1997) which resulted in a new part 351 Cigars and cigarettes, Computer 21 CFR Part 870
and the deletion of parts 353 and 355. technology, Countervailing duties [Docket No. FDA–2017–N–1620]
Accordingly, this document makes (Liquidation of duties), Customs duties
conforming changes to §§ 159.58(a) and and inspection, Discriminating duties, Medical Devices; Cardiovascular
159.58(b) to reflect this revision. Entry procedures, Foreign currencies, Devices; Classification of the
Import, Liquidation of entries for Adjunctive Cardiovascular Status
Part 181 merchandise, Suspension of liquidation Indicator
pending disposition of American
Subpart D of Part 181 of title 19 deals AGENCY: Food and Drug Administration,
manufacturer’s cause of action, Value
with post-importation duty refund content. HHS.
claims under the North American Free ACTION: Final order.
Trade Agreement (NAFTA). Section 19 CFR Part 181
181.33(d)(1) lists instances wherein a SUMMARY: The Food and Drug
Administrative practice and Administration (FDA) is classifying the
port director may deny a post- procedure, Canada, Customs duties and
importation duty refund claim for adjunctive cardiovascular status
inspection, Exports, Imports, Mexico, indicator into class II (special controls).
preferential tariff treatment for imported Reporting and recordkeeping
goods under the NAFTA, and it The special controls that will apply to
requirements, Trade agreements (North the device are identified in this order
references § 181.32(b)(3) in the context American Free-Trade Agreements).
of the validity of a Certificate of Origin. and will be part of the codified language
Amendments to the Regulations for the adjunctive cardiovascular status
This is not the correct reference. The
indicator’s classification. The Agency is
proper reference should be to For the reasons set forth above, parts classifying the device into class II
§ 181.32(b)(2), which references the 159 and 181 of the CBP regulations (19 (special controls) in order to provide a
requirement to file a Certificate of CFR parts 159 and 181) are amended as reasonable assurance of safety and
Origin with respect to the imported set forth below. effectiveness of the device.
goods. Accordingly, this document
PART 159—LIQUIDATION OF DUTIES DATES: This order is effective July 28,
makes changes to § 181.33(d)(1) to
2017. The classification was applicable
reference § 181.32(b)(2) instead of
■ 1. The general authority citation for on December 21, 2016.
§ 181.32(b)(3).
part 159 continues to read as follows: FOR FURTHER INFORMATION CONTACT:
Inapplicability of Notice and Delayed Authority: 19 U.S.C. 66, 1500, 1504, 1624. Nathalie Yarkony, Center for Devices
Effective Date and Radiological Health, Food and Drug
* * * * * Administration, 10903 New Hampshire
As the technical corrections set forth Ave., Bldg. 66, Rm. 1254, Silver Spring,
§ 159.58 [Amended]
in this document merely conform to MD 20993–0002, 301–796–1235,
existing law and regulation, CBP finds ■ 2. Section 159.58 is amended: nathalie.yarkony@fda.hhs.gov.
that good cause exists for dispensing ■ a. In paragraph (a) by removing the
SUPPLEMENTARY INFORMATION:
with notice and public procedure as term ‘‘part 353’’ and adding in its place
unnecessary under 5 U.S.C. 553(b)(B). the term ‘‘part 351’’; and I. Background
For this same reason, pursuant to 5 ■ b. In paragraph (b) by removing the In accordance with section 513(f)(1) of
U.S.C. 553(d)(3), CBP finds that good term ‘‘part 355’’ and adding in its place the Federal Food, Drug, and Cosmetic
cause exists for dispensing with the the term ‘‘part 351’’. Act (the FD&C Act) (21 U.S.C.
requirement for a delayed effective date. 360c(f)(1)), devices that were not in
PART 181—NORTH AMERICAN FREE commercial distribution before May 28,
Regulatory Flexibility Act TRADE AGREEMENT 1976 (the date of enactment of the
Because this document is not subject Medical Device Amendments of 1976),
■ 3. The authority citation for part 181
to the notice and public procedure generally referred to as postamendments
continues to read as follows:
requirements of 5 U.S.C. 553, it is not devices, are classified automatically by
Authority: 19 U.S.C. 66, 1202 (General statute into class III without any FDA
subject to the provisions of the Note 3(i), Harmonized Tariff Schedule of the
Regulatory Flexibility Act (5 U.S.C. 601 rulemaking process. These devices
United States (HTSUS)), 1624, 3314.
et seq.). remain in class III and require
Subpart D of part 181 also issued under 19
U.S.C. 1520(d). premarket approval unless and until the
Executive Order 12866 device is classified or reclassified into
§ 181.33 [Amended] class I or II, or FDA issues an order
These amendments do not meet the finding the device to be substantially
criteria for a ‘‘significant regulatory ■ 4. Section 181.33(d)(1) is amended by
removing the citation ‘‘§ 181.32(b)(3)’’ equivalent, in accordance with section
action’’ as specified in Executive Order 513(i) of the FD&C Act, to a predicate
and adding in its place the citation
asabaliauskas on DSKBBXCHB2PROD with RULES
12866, as supplemented by Executive device that does not require premarket
Order 13563. ‘‘§ 181.32(b)(2)’’.
approval. The Agency determines
Dated: July 24, 2017. whether new devices are substantially
Signing Authority
Kevin K. McAleenan, equivalent to predicate devices by
This document is limited to technical Acting Commissioner, U.S. Customs and means of premarket notification
corrections of the CBP regulations. Border Protection. procedures in section 510(k) of the
Accordingly, it is being signed under [FR Doc. 2017–15888 Filed 7–27–17; 8:45 am] FD&C Act (21 U.S.C. 360(k)) and part
the authority of 19 CFR 0.1(b)(1). BILLING CODE 9111–14–P 807 (21 CFR part 807) of the regulations.
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![Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Rules and Regulations 35067
information found in other FDA algorithm(s) must be provided. DEPARTMENT OF HEALTH AND
regulations. These collections of Verification of algorithm calculations HUMAN SERVICES
information are subject to review by the and validation testing of the algorithm
Office of Management and Budget using a data set separate from the Food and Drug Administration
(OMB) under the Paperwork Reduction training data must demonstrate the
Act of 1995 (44 U.S.C. 3501–3520). The validity of modeling. 21 CFR Part 876
collections of information in part 807, (3) Usability assessment must be
[Docket No. FDA–2017–N–1609]
subpart E, regarding premarket provided to demonstrate that risk of
notification submissions have been misinterpretation of the status indicator Medical Devices; Gastroenterology-
approved under OMB control number is appropriately mitigated. Urology Devices; Classification of the
0910–0120, and the collections of (4) Clinical data must be provided in Oral Removable Palatal Space
information in 21 CFR part 801, support of the intended use and include Occupying Device for Weight
regarding labeling have been approved the following: Management and/or Weight Loss
under OMB control number 0910–0485. (i) Output measure(s) must be
compared to an acceptable reference AGENCY: Food and Drug Administration,
List of Subjects in 21 CFR Part 870 method to demonstrate that the output HHS.
Medical devices. measure(s) represent(s) the predictive ACTION: Final order.
Therefore, under the Federal Food, measure(s) that the device provides in
Drug, and Cosmetic Act and under an accurate and reproducible manner; SUMMARY: The Food and Drug
authority delegated to the Commissioner (ii) The data set must be Administration (FDA or Agency) is
of Food and Drugs, 21 CFR part 870 is representative of the intended use classifying the oral removable palatal
population for the device. Any selection space occupying device for weight
amended as follows:
criteria or limitations of the samples management and/or weight loss into
PART 870—CARDIOVASCULAR must be fully described and justified; class II (special controls). The special
DEVICES (iii) Agreement of the measure(s) with controls that will apply to the device are
the reference measure(s) must be identified in this order and will be part
■ 1. The authority citation for part 870 assessed across the full measurement of the codified language for the oral
continues to read as follows: range; and removable palatal space occupying
(iv) Data must be provided within the device for weight management and/or
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
clinical validation study or using weight loss classification. The Agency is
equivalent datasets to demonstrate the classifying the device into class II
■ 2. Add § 870.2200 to subpart C to read consistency of the output and be
as follows: (special controls) in order to provide a
representative of the range of data reasonable assurance of safety and
sources and data quality likely to be
§ 870.2200 Adjunctive cardiovascular effectiveness of the device.
status indicator. encountered in the intended use
population and relevant use conditions DATES: This order is effective July 28,
(a) Identification. The adjunctive 2017. The classification was applicable
cardiovascular status indicator is a in the intended use environment.
(5) Labeling must include the on September 26, 2016.
prescription device based on sensor
following: FOR FURTHER INFORMATION CONTACT:
technology for the measurement of a (i) The type of sensor data used, Mark Antonino, Center for Devices and
physical parameter(s). This device is including specification of compatible Radiological Health, Food and Drug
intended for adjunctive use with other sensors for data acquisition; Administration, 10903 New Hampshire
physical vital sign parameters and (ii) A description of what the device Ave., Bldg. 66, Rm. G208, Silver Spring,
patient information and is not intended measures and outputs to the user; MD, 20993–0002, 240–402–9980,
to independently direct therapy. (iii) Warnings identifying sensor mark.antonino@fda.hhs.gov.
(b) Classification. Class II (special reading acquisition factors that may
controls). The special controls for this SUPPLEMENTARY INFORMATION:
impact measurement results;
device are: (iv) Guidance for interpretation of the I. Background
(1) Software description, verification, measurements, including warning(s)
and validation based on comprehensive In accordance with section 513(f)(1) of
specifying adjunctive use of the the Federal Food, Drug, and Cosmetic
hazard analysis must be provided, measurements;
including: Act (the FD&C Act) (21 U.S.C.
(v) Key assumptions made in the
(i) Full characterization of technical 360c(f)(1)), devices that were not in
calculation and determination of
parameters of the software, including commercial distribution before May 28,
measurements;
any proprietary algorithm(s); 1976 (the date of enactment of the
(vi) The measurement performance of
(ii) Description of the expected impact Medical Device Amendments of 1976),
the device for all presented parameters,
of all applicable sensor acquisition generally referred to as postamendments
with appropriate confidence intervals,
hardware characteristics on devices, are classified automatically by
and the supporting evidence for this
performance and any associated statute into class III without any FDA
performance; and
hardware specifications; (vii) A detailed description of the rulemaking process. These devices
(iii) Specification of acceptable patients studied in the clinical remain in class III and require
incoming sensor data quality control validation (e.g., age, gender, race/ premarket approval, unless and until
asabaliauskas on DSKBBXCHB2PROD with RULES
measures; and ethnicity, clinical stability) as well as the device is classified or reclassified
(iv) Mitigation of impact of user error procedural details of the clinical study. into class I or II, or FDA issues an order
or failure of any subsystem components finding the device to be substantially
(signal detection and analysis, data Dated: July 24, 2017. equivalent, in accordance with section
display, and storage) on accuracy of Leslie Kux, 513(i) of the FD&C Act, to a predicate
patient reports. Associate Commissioner for Policy. device that does not require premarket
(2) Scientific justification for the [FR Doc. 2017–15901 Filed 7–27–17; 8:45 am] approval. The Agency determines
validity of the status indicator BILLING CODE 4164–01–P whether new devices are substantially
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Document Created: 2017-07-28 03:10:59
Document Modified: 2017-07-28 03:10:59
| 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 July 28, 2017. The classification was applicable on December 21, 2016. | |
| Contact | Nathalie Yarkony, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993-0002, 301- 796-1235, [email protected] | |
| FR Citation | 82 FR 35065 |
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