CDRH Official Links Re-Org To Drop In Warning Letter Count
Far fewer warning letters are being issued by the US FDA’s device center than in previous years. A center compliance official said that in addition to changes in enforcement practices, the drop was also influenced by CDRH’s recent move to centralize device review staff in the so-called “super-office.”
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A Record-Low 24 Warning Letters Were Sent To Device Firms In 2018. That's Because A 'Big Hammer' Isn't The Best Tool To Ensure Compliance, FDA Says
Only two dozen quality-related warning letters were sent by the US agency to device-makers in calendar year 2018 – the fewest ever issued to companies since the FDA's Quality System Regulation came into force in 1996. Two FDA officials share with Medtech Insight probable reasons for the decline in the enforcement missives, from regulatory meetings with firms to untitled letters, and more.
Speaking at MedCon 2019, CDRH Director Jeff Shuren announced 1 May is officially the first day for the agency’s new Office of Product Evaluation and Quality. The agency lists several examples of how it has already been used in a pilot setting to remove potentially harmful products from market sooner, and resulted in more efficient and safer product reviews.
Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites
The pursuit of quality can be a daunting task for device-makers. One wrong step can cause costly product recalls affecting patient health – among other troubles tied to poor quality products and processes. To help firms move toward a goal of best-in-industry quality, US FDA, through its Case for Quality initiative, has convened a pilot program to measure a manufacturer's capability and maturity to help put it on a path to continuous improvement. The pilot uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method, developed jointly by FDA, industry and CMMI Institute.
The first of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.