What happened to Part 804? 820.198 (3) references part 803 or 804

[bigup1ca]

Hi All,

Wanted to find out if any of the long timers here in the cove know what happened to Part 804? 820.198 (3) references part 803 or 804, but the current regs do not have a part 804. What did 804 pertain to and was 804 language absorbed into 803? Just curious.

 

[MIREGMGR]

Re: 21 CFR Part 804

Specifically where is the reference?

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.198

This current source provides the amendment record, by date and publication info.

I don't see "804"...maybe I'm missing it?

 

[Ajit Basrur]

21 CFR Part 804 could be found HERE
but strangely NOT HERE in the Index of all CFRs

Strange - in one of the most recent approved 510 (K) summary from FDA, http://www.fda.gov/cdrh/pdf8/K083717.pdf they mention -

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 804)-good-manufacturing-practice- requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

 

[Ajit Basrur]

Further search gave the following -

In the Federal Register of January 26,200O (65 FR 4112), FDA published a final rule (the January 2000 rule) that amended its MDR regulations governing reporting by manufacturers, importers, distributors, and user facilities of adverse events related to medical devices. These amendments were made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the
act) under the Food and Drug Administration Modernization Act of 1997 (FDAMA). These regulations became effective March 27,200O. Under certain provisions of FDAMA, reporting requirements for distributors were eliminated, but reporting requirements for importers, and requirements for distributors to keep records concerning adverse device events and make them available to FDA upon request continue to apply. To accommodate these changes, part 804 (21 CFR part 804) was removed and language was integrated into part 803 (21 CFR part 803) that reflected the retention of importer reporting requirements and recordkeeping requirements for distributors.

 

[MIREGMGR]

See this page:

http://www.fda.gov/CDRH/devadvice/351.html

The FDA Modernization Act of 1997 (FDAMA) Changes to medical device adverse event reporting (MDR) became effective on February 19, 1998. On January 26, 2000, we published in the Federal Register changes to the implementing regulations, 21 CFR 803 and 804, to reflect these amendments in the act. Also, Part 804 was removed.

Bold by me, not the FDA, of course.