Reports
| Currency | Current through May 31, 2023 |
| Citation | 21 C.F.R. §814.84 |
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White v. Stryker Corp., Civil Action No. 3:10–CV–544–H.
- United States
- U.S. District Court — Western District of Kentucky
- 25 Marzo 2011
...a PMA approval order state that continued approval of the PMA “is contingent on the submission of postapproval reports required under 21 C.F.R. 814.84 at intervals of 1 year from the date of approval of the original PMA.” 3 These reports must identify all manner of events and occurrences th......