21 U.S.C. § 360c–1 — Reporting

submitted 14 years ago by Pub. L. 112-144 to r/title-21-FOOD-AND-DRUGS · 105 words · no verdicts yet

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The FDA must publish yearly device reclassification counts online. This covers devices moved between classes I, II, and III under section 360c(e)(1). It also covers devices reclassified under section 360e.

Every year, the Secretary of Health and Human Services must post a report on the FDA's website. That report must show three things: (1) how many, and what type, of class I and class II devices were reclassified as class II or class III in the past year, under section 360c(e)(1); (2) how many, and what type, of class II and class III devices were reclassified as class I or class II in the past year, under that same section 360c(e)(1); and (3) how many, and what type, of devices were reclassified in the past year under section 360e.

the actual law source: uscode.house.gov ↗public domain

The Secretary of Health and Human Services shall annually post on the Internet Web site of the Food and Drug Administration—

(1)

the number and type of class I and class II devices reclassified as class II or class III in the previous calendar year under section 360c(e)(1) of this title;

(2)

the number and type of class II and class III devices reclassified as class I or class II in the previous calendar year under such section 360c(e)(1) of this title; and

(3)

the number and type of devices reclassified in the previous calendar year under section 360e of this title.

Source credit: (Pub. L. 112–144, title VI, § 608(c), July 9, 2012, 126 Stat. 1059.)

history & why it existsrecord from the source credit

2012Enacted · Pub. L. 112-144 · 126 Stat. 1059

A history note hasn’t been published yet. The record shows enactment by Pub. L. 112-144 on 2012-07-09.

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