quality system regulation

Preparing for an FDA QSR Inspection: Do’s, Don’t and Maybe’s

EMERGO SUMMARY OF KEY POINTS:

  • FDA Quality System Regulation (QSR) inspections occur on an unannounced, “surprise” basis.
  • FDA quality inspection methods and approaches are laid out in the Quality System Inspection Technique (QSIT) guidelines.
  • Manufacturers should conduct internal audits of their quality systems on a regular basis to ensure 21 CFR Part 820 compliance and address any issues before an actual FDA inspection occurs.

MDSAP Authorities Push for Medical Device Industry Participation

Officials overseeing the Medical Device Single Audit Program (MDSAP) developed to allow single quality system audits across multiple regulatory jurisdictions have issued an official request for participation to medical device manufacturers ahead of the program’s full implementation deadline.

FDA Report: More QSR Inspections at Foreign Sites in 2014

The US Food and Drug Administration increased its number of quality system inspections at foreign medical device manufacturing sites in 2014, expanding on its years-long effort to monitor FDA Good Manufacturing Practice compliance at sites based outside the US.

US FDA: Functional Equivalence for Reformulated Sterilization Product from DuPont

US medical device regulators have notified registrants that production changes to a commonly used sterilization product from DuPont will likely not warrant new 510(k) or Premarket Notification (PMA) filings from device manufacturers.

CDRH: 577 Warning Letter Cites Issued in 2010

The US FDA’s Center for Devices and Radiological Health has released data on warning letter cites regarding manufacturers’ quality system deficiencies in 2010.