Are you a device or combination products manufacturer or service provider?
AAMI has just released an important document mapping US 21CFR 820 to the Medical Device Standard ISO 13485. If you have not started or are behind in your harmonization efforts, I would strongly urge a review of your Quality Manual and Quality System using this document to assure full harmonization by the due date.
Some firms may be delayed in their harmonization efforts; many firms producing combination products were delayed in implementing US21 CFR Part 4. There was a range of responses from Industry to the Part 4 requirements. Some firms were betting on the fact that FDA would be slow to enforce against new Part 4 requirements. Some firms were slow to comply due to the investment required. Some firms were in full compliance. Today, there are some firms still working on CAPAs to achieve full compliance with Part 4.
We have seen industry shortages for important combination products since Part 4 was implemented due to lack of compliance with Part 4; FDA has proven they will not hesitate to cite firms not in compliance with the new requirements.
