In Brief: PMAs for obsolete devices
This article was originally published in The Gray Sheet
Executive SummaryPMAs for obsolete devices: FDA issues proposed call for PMAs for 43 "disused" preamendments Class III devices in a Sept. 7 Federal Register notice. FDA does not expect any viable premarket approval applications or petitions for reclassification to be submitted because the devices have fallen into disuse. Comments on the proposal are due Jan. 5, 1996, and requests for reclassification of the devices are due Sept. 22. FDA initially identified the devices in an announcement in the May 6, 1994 Federal Register ("The Gray Sheet" May 9, p. 14)...
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