US Agent and eMDR

[Cybel]

Hello everyone,

I was reviewing our procedure for eMDR.

The 21 CFR 803.58 b) says that US Agent of foreign manufacturers is required to report to FDA according to §§ 803.50, 803.52, 803.53, and 803.56 (articles about adverse events reporting)

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while here U.S. Agents FDA says that US agents have no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803).

I think it is inconsistent, I'm probably wrong but I cannot understand why.

Can anyone clarify this point?

Thanks!!

 

[indubioush]

It is because of this:

"XI. Stayed CFR Text

FDA has many revisions for 21 CFR part 803; therefore, we are revising the entire part. .... Section 803.58, which is currently under indefinite stay (published at 61 FR 38346, July 23, 1996), includes in subsection (b)(1) a reference to the former § 803.55. For purposes of this rulemaking, FDA is temporarily lifting the stay of § 803.58 in order to remove the reference to § 803.55. Because FDA is only lifting the stay for this purpose, we are also reimposing the indefinite stay of § 803.58 in this final rule. FDA intends to consider the § 803.58 requirements for U.S.-designated agents in a separate rulemaking."

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Federal Register :: Request Access (read the note at the bottom)

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https://www.govinfo.gov/content/pkg/FR-1996-07-23/pdf/96-18700.pdf

All of this means that this section of the regulation is not currently in effect and is kind of in limbo.

 

[Cybel]

Thank you so much!!