FDA Releases Guidance for Industry on Inspection Program for Medical Devices

Summary

The Food and Drug Administration (FDA) has announced the availability of a new guidance document outlining the eligibility criteria and process for requesting FDA approval to have a third-party inspector conduct establishment inspections for class II or class III medical devices under the Inspections by Accredited Persons Program (AP Program), authorized by the Medical Device User Fee and Modernization Act of 2002.