Zdrowie i gospodarka · 17/12/2015

FDA Terminates Medical Device ISO Pilot Program, Announces Participation in MDSAP

The FDA is ending its Medical Device ISO Voluntary Audit Report Pilot Program, which allowed third-party audits to exempt medical device owners from routine inspections for up to a year. The agency will now use audit reports from the Medical Device Single Audit Program (MDSAP) for inspections.