News

CDRH Guidance Supports Third-Party Inspection Pilot for Medical Devices


Posted in Regulatory and Compliance by Jamie Hartford on December 5, 2013

CDRH hopes the audits will reduce the frequency of routine inspections by its own investigators. 


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.

Stay up to date on the goings-on at FDA by attending the FDA and Global Regulations in Practice conference track at MD&M West in Anaheim, CA, February 10–13, 2014.

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.

Stay up to date on the goings-on at FDA by attending the FDA and Global Regulations in Practice conference track at MD&M West in Anaheim, CA, February 10–13, 2014.

Jim Dickinson is a contributing editor to MD+DI.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET] 


Tags:
Printer-friendly version
Your rating: None Average: 5 (1 vote)

Login or register to post comments

PMA applications or to

PMA applications or to decisions concerning a device classificationon topics that plenty are interested on.I concur with your conclusions and will eagerly look forward to your future updates.Friends seasons 1-10 DVD Box set|Rules of Engagement Seasons 1-5 DVD Box set|The Walking Dead seasons 1-3 DVD Box set|Supernatural Seasons 1-8 DVD Box set|The office seasons 1-9 DVD Box set|Grey's anatomy seasons 1-9 DVD Box set