Food and Drug Administration, HHS.
Final order; correction.
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.
Effective October 10, 2017.
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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.email@example.com.
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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 Start Printed Page 46901whether 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)).
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.”
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Dated: October 2, 2017.
Associate Commissioner for Policy.
[FR Doc. 2017-21659 Filed 10-6-17; 8:45 am]
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