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SMITH & NEPHEW BHR – FDA Papers – Appendix G:  Summary of MoM Hip Resurfacing Post-Approval Studies

Source: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309356.pdf.

Download PDF here: SMITH & NEPHEW BHR – FDA Papers – Appendix G Summary of MoM Hip Resurfacing Post-Approval Studies

Post-approval studies (PAS) are one mechanism by which FDA can obtain longer-term safety and/or effectiveness data for a device as a condition of approval for a premarket application (PMA), humanitarian device exemption (HDE), or product development plan (PDP) process.

However, PAS is not a substitute for obtaining the necessary premarket information to support PMA, HDE, or PDP approval.

The three hip resurfacing systems were approved by FDA and are subject to PAS conditions of approval.  The study protocols for each of the conditions of approval are outlined below.  All of the information in these tables is available at the PAS public webpage:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm?sb=ms

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