U.S. Agents - Responsibility for reporting adverse events to the FDA

Ajit Basrur

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#11
XI. Stayed CFR Text

https://www.gpo.gov/fdsys/pkg/FR-2014-02-14/pdf/2014-03286.pdf#page=1

FDA has many revisions for 21 CFR part 803; therefore, we are revising the entire part. At 73 FR 33692, published June 13, 2008, FDA amended the MDR regulation to remove § 803.55, which established the requirement for baseline reports. 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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