Neil A Mafnas CDR USPHS International Affairs Team Center for Devices and Radiological Health US FDA Medical Device Single Audit Program MDSAP Assess and Recognize Regulatory Authorities RA ID: 1042410
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1. Medical Device Single Audit Program Overview & UpdateNeil A. Mafnas, CDR, USPHSInternational Affairs TeamCenter for Devices and Radiological HealthU.S. FDA
2. Medical Device Single Audit Program (MDSAP)Assess and RecognizeRegulatory Authorities (RA)Manufacturers(>6500 individual sites worldwide)Interface MDSAP - Other RA Regulatory ProcessesAuditing Organizations (AO)(16 total)RegulatoryDecisionsAudit and CertifyShare Audit ReportMDSAPOther Info
3. “The goal of the MDSAP is to provide for more effective, efficient and less burdensome regulatory oversight of the quality management systems of medical device manufacturers.” （SOC of MDSAP)
4. Other MembershipObserversAffiliatesEuropean UnionArgentinaUnited KingdomIsraelWorld Health OrganizationSouth KoreaSingapore
5. Auditing OrganizationsAuthorizedRecognizedApplication Received
6. Facilities: 6,558Certificate Holders: 5,090From 2018-2022Audit Reports Submitted: 17,625Audit with at least one NC: 10,528 (60%)Nonconformances: 37,9945-Day Notice Audit Reports: 165Public Threat Flag: 7Fraudulent Activity Flag: 1MDSAP Overall Numbers*Data as of 1/30/2023
7. MDSAP Participating Facilities
8. MDSAP Sites by Country
9. Audit Reports Received by JurisdictionJurisdiction20182019202020212022TotalAustralia1797283133113335169512969Brazil1576235127152782141510839Canada2335376743304261227016963Japan1540228756112699130110438US220535114874116221416133
10. MDSAP Participant Where are They?
11. MDSAP Participant Where are They?
12. MDSAP Participant Where are They?
13. MDSAP Participant Where are They?
14. 24 Assessments of Auditing Organizations2,397 Audit Reports Submitted528 New MDSAP SitesTransition of the MDSAP IT Portal from PAHO to FDAMid-Year and End of Year Annual ForumAddition of Israel as Affiliate Member2022 Accomplishments
15. Improve documentation of nonconformities in audit reportsLaunch Pilot to permit hybrid/remote audit practices in a post-pandemic world2023 Annual Forum(s)Publish MDSAP Roles & Responsibilities Document (completed 1/6/2023)2023 Activities
16. Escalation rule from Affiliate to Observer, Observer to RAC MemberClarification of expected contribution per each membership categoryFeatures of the New CriteriaAffiliateObserverRAC Member3 years2 yearsContributionMDSAP Membership Model
17. Please send any questions to MDSAP@fda.hhs.gov
18.