Document ID: FDA-2017-N-1620-0002
Agency: fda
Document Type: Rule
Title: Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator; Correction
Posted Date: 2017-10-10T04:00Z

[Federal Register Volume 82, Number 194 (Tuesday, October 10, 2017)]
[Rules and Regulations]
[Pages 46900-46901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21659]

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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; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
order entitled ``Medical Devices; Cardiovascular Devices; 
Classification of the Adjunctive Cardiovascular Status Indicator'' that 
appeared in the Federal Register of July 28, 2017. The final order was 
published with an incorrect statement in the preamble about whether FDA 
planned to exempt the device from premarket notification requirements. 
This document corrects that error.

DATES: Effective October 10, 2017.

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, 
Nathalie.yarkony@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 28, 2017 (82 
FR 35065), FDA published the final order ``Medical Devices; 
Cardiovascular Devices; Classification of the Adjunctive Cardiovascular 
Status Indicator.'' The final order published with an incorrect 
statement in the preamble about

[[Page 46901]]

whether FDA planned to exempt the device from premarket notification 
requirements under section 510(k) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)).

Correction

    In the Federal Register of July 28, 2017, in FR Doc. 2017-15901, 
the following correction is made:
    On page 35066, at the bottom of the page below table 1, beginning 
in the first column, the third paragraph is corrected as follows:
    ``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 has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the adjunctive cardiovascular status 
indicator they intend to market.''

    Dated: October 2, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21659 Filed 10-6-17; 8:45 am]
 BILLING CODE 4164-01-P