PMA Review Costs Pooled In Unit-Cost Analysis; CDRH To Monitor Modules
This article was originally published in The Gray Sheet
Executive Summary
FDA's cost study of its device review resources likely will consolidate labor data for traditional, modular, expedited and panel-track PMAs into one cohort, rather than track each application type separately
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Guidant ICDs: Three deaths have now been associated with clinical failures of Guidant's Contak Renewal and Renewal 2 implantable cardioverter defibrillators that were manufactured on or before Aug. 26, 2004, according an 1Oct. 13 Preliminary Public Health Notification from FDA. The notice updates a July 14 agency communication about malfunctions with the Renewal products as well as the Ventak Prizm 2 ICDs, which led to a Class I recall (2"The Gray Sheet" June 20, 2005, p. 19). Guidant has reported a total of 49 instances of these ICDs exhibiting the specified failure mode...
Regulatory News In Brief
Guidant ICDs: Three deaths have now been associated with clinical failures of Guidant's Contak Renewal and Renewal 2 implantable cardioverter defibrillators that were manufactured on or before Aug. 26, 2004, according an 1Oct. 13 Preliminary Public Health Notification from FDA. The notice updates a July 14 agency communication about malfunctions with the Renewal products as well as the Ventak Prizm 2 ICDs, which led to a Class I recall (2"The Gray Sheet" June 20, 2005, p. 19). Guidant has reported a total of 49 instances of these ICDs exhibiting the specified failure mode...
Device User-Fee Payment Made User-Friendly: Electronic Tracking Simplified
Manufacturers submitting product applications to multiple FDA centers could benefit the most from ongoing attempts to streamline user fee billing processes throughout the agency