May 23, 2011

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

The CDRH sent out 89 warning letters containing 577 cites in total last year, primarily pertaining to corrective and preventative actions (CAPAs) and production and process controls (P&PC), which respectively accounted for 186 and 168 cites.

In terms of CAPA subsystem deficiencies cited by the regulator, 21 CFR 820.100 (Subpart J of the Quality System Regulation) caused the most problems, apparently, warranting 83 warnings from the CDRH. Another 78 cites were caused by 21 CFR 820.198 (complaint files), followed distantly by 21 CFR 820.90 (nonconforming product), for which the regulator cited 25 deficiencies.

In the P&PC category, the CDRH cited 35 deficiencies for 21 CFR 820.70 (production and process controls), as well as 34 deficiencies apiece for 21 CFR 820.75 (process validation) and 21 CFR 820.80 (receiving, in-process and finished device acceptance).

The new CRDH figures clearly point out which quality system compliance areas are creating the biggest challenges for manufacturers, as CAPA and P&PC deficiencies significantly outnumbered design, management and document control cites. 

Author

  • Stewart Eisenhart

Related

CDRH 2012 Strategic Priorities: Familiar Themes

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published its 2012 Strategic Priorities, which include improvements to pre- and post-market processes, internal and external communications, and efforts to support innovative product development.

Read more

CDRH Audit: Majority of NSE Determinations Due to Inadequate Performance Data from Sponsors

A recent audit of the Food and Drug Administration’s 510(k) program by the Center for Devices and Radiological Health (CDRH) has found that inadequate device performance data submissions from sponsors make up a substantial majority--80%--of Not Substantially Equivalent (NSE) determinations made by the agency between 2005 and 2010.

The analysis covered more than 700 NSE determinations made during the course of that six-year period. NSE determinations were based either on failure to provide appropriate performance data to support substantial equivalence (SE) determinations, or to demonstrate equivalent performance compared to predicate devices.

Read more

CDRH Process for Resolving Internal Medical Device Review Disagreements Needs Improving

Processes in place to resolve scientific disagreements among FDA medical device reviewers need stronger definitions and clearer lines of responsibility, according to the US Health and Human Service

Read more

Have questions on what Emergo can do for you?

CONTACT US