Can non-participating RAs have access to MDSAP audit reports? How can the veracity of certificates be confirmed?

Each RA participating in the MDSAP RAC and Official Observers have access to MDSAP audit reports. 

RAs not participating in the MDSAP will not have full access to audit reports or certificates. Nevertheless, if an RA has a confidentiality agreement with an MDSAP RA, a request may be made to that authority, to obtain a copy of a particular report.

MDSAP Affiliate Members and non-participating RAs may request audit reports and certificates from the medical device manufacturer.

Inquiries regarding any the authenticity of audit reports (not certificates) can be sent to MDSAP@fda.hhs.gov. MDSAP RAs do not have access to certificates. To verify a certificate, please reach out directly to the issuing AO.