Devices

Don’t Underestimate Device Quality System Inspection Changes: Column

While many elements of QMSR (Quality Management System Regulation) inspections will feel familiar, the shift as of the 2/2 compliance date toward evaluating the entire Quality Management System (QMS), the increased emphasis on risk management integration, and the broader discretion afforded to investigators “represent meaningful changes that manufacturers should not underestimate.” That’s the view of Hyman, Phelps & McNamara’s principal medical device regulation expert Adrienne Lentz, writing in the firm’s FDA Law Blog.

Lentz reports on the 4/1 FDA Town Hall that reviewed the updated “Inspection of Medical Device Manufacturer Compliance Program Manual,” the CP. Agency officials summarized the two inspection models and said that, unlike prior inspections under the Quality System Inspection Technique, each inspection will now include evaluation of each area of a company’s Quality Management System.

An expert panel charged with responding to frequently asked questions related to inspections under the QSMR and the new CP made several points:

under QMSR inspections, FDA will emphasize risk management documents and risk controls throughout the QMS;
the inspection process will be largely the same under the CP as it was under QSIT, with some notable differences; and
the culture of quality that FDA is looking for is reflected in decisions made and actions taken by companies throughout the QMS and not through any particular steps to document a quality culture.

The agency noted that manufacturers should ensure their internal audit program is evaluating how risk management is integrated throughout product development, how a risk-based approach is used throughout the QMS, and how risk controls are implemented in each affected process.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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