21 CFR Part 878, Subpart F - Therapeutic Devices | US Law

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Title 21 published on 2015-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

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2015-08-05; vol. 80 # 150 - Wednesday, August 5, 2015

80 FR 46485 - Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker

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Additional Documents

type	regulations.gov
FR Doc.	2015-19177
RIN
Docket No.	FDA-2015-N-2457

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final order.

This order is effective August 5, 2015. The classification was applicable on December 18, 2014.

21 CFR Part 878

Summary

The Food and Drug Administration (FDA) is classifying the internal tissue marker 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 internal tissue marker'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.

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

§ 360l - Postmarket surveillance

§ 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 878 after this date.