21 CFR Part 872, Subpart B - Diagnostic Devices | US Law

Title 21 published on 2015-04-01.

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2015-11-20; vol. 80 # 224 - Friday, November 20, 2015

80 FR 72585 - Dental Devices; Reclassification of Electrical Salivary Stimulator System

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type	regulations.gov
FR Doc.	2015-29638
RIN
Docket No.	FDA-2014-N-1243

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final order.

This order is effective December 21, 2015.

21 CFR Part 872

Summary

The Food and Drug Administration (FDA) is issuing a final order to reclassify the salivary stimulator system, a postamendments Class III device, into class II (special controls) and to rename the device the “electrical salivary stimulator system.” 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.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

U.S. Code: Title 21 - FOOD AND DRUGS

§ 351 - Adulterated drugs and devices

§ 360 - Registration of producers of drugs or devices

§ 360c - Classification of devices intended for human use

§ 360e - Premarket approval

§ 360j - General provisions respecting control of devices intended for human use

§ 371 - Regulations and hearings

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 872 after this date.