The FDA is looking for a few good device companies to help the agency identify manufacturing process gaps that could lead, in their words, to safer and higher quality devices while reducing the regulatory burden on manufacturers.
Device Makers Sought for FDA Pilot Quality Program
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In December, the agency’s Center for Devices and Radiological Health (CDRH) released details on its upcoming voluntary medical device manufacturing and product quality pilot program as part of its Case for Quality (CfQ) initiative.
According to the Regulatory Affairs Professional Society (RAPS), the pilot program, features a capability maturity model integration (CMMI) system, “adapted to suit the needs of the device industry.” The program, according to RAPS, “will focus on appraising device makers’ current manufacturing process performance based on ‘objective metrics, optimization of resources and impact on quality culture.”
The agency is looking for nine device makers “who provide a holistic representation of the medical device industry.” Each company, reports RAPS, “will undergo an appraisal and will be exempt from routine FDA surveillance inspections during the pilot, though FDA says it will still conduct any necessary ‘for cause’ inspections.”
The agency is also looking for ways to engage with device makers that are interested in participating in the pilot but are not officially selected to participate.
Participating device makers will receive the results of their appraisal from the CMMI Institute, and a summary report of the appraisal will be provided to the FDA for each manufacturer.
What’s in this for manufacturers?
The agency says industry participation is critical to long-term implementation of the maturity model as an alternative to the traditional path of a routine FDA inspection. Benefits to manufacturers include:
- Increased manufacturing and product confidence
- Faster time to market
- Better information to drive regulatory decisions
- Improved resource allocation
- A continuous improvement focus on what is most important to patients
If you want to sign up, you better hurry because the agency says slots will fill up fast.
To sign up, contact Stephanie Christopher, Program Director, Email: schristopher@mdic.org, Phone: 952-314-2730. Or click here to get answers to questions.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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