CDRH Guidance Supports Third-Party Inspection Pilot for Medical Devices

By Jim Dickinson        

FDA has posted a guidance to support a CDRH-backed medical device single audit pilot (MDSAP) program that will begin in January to reduce inspection burdens for the center, international regulators, and industry.

The single audits, which will mostly be performed by third-party organizations and certain regulatory inspectorates, will reduce the frequency of routine inspections performed by FDA investigators, so they can focus more on for-cause and targeted risk-based inspections.

Under the pilot, CDRH will accept the single-audit reports as a substitute for FDA routine inspections, according to the guidance. Inspections conducted “for cause” or “compliance follow-up” by FDA will not be affected by this program, it says. Moreover, the program will not apply to any necessary pre- or postapproval inspections for PMA applications or to decisions concerning a device classification.

Additionally, the pilot calls for auditing organizations to be assessed and monitored by FDA and other regulatory authorities.

“This program includes a robust plan and schedule for assessing the competence and compliance of MDSAP auditing organizations to include assessments of their head office and critical sites, as well as performing assessments during witnessed audits, as part of a four-year recognition process,” the guidance says.

Jim Dickinson is a contributing editor to MD+DI.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]