Medical Devices: FDA Should Strengthen Policies Guiding Audits of Third Party Review Organizations

Filed 1h ago · Via GAO · The Buffoon Desk

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Kevin MacLeod · incompetech.com · CC BY 4.0

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GAO reviewed the FDA's Third Party Review Program, which lets accredited outside organizations conduct initial reviews of certain low-to-moderate risk medical devices like surgical lasers and ultrasound systems before the agency makes a final call. The program handled 617 submissions from 2018 through 2025, about 2 percent of the agency's annual device review workload.

The report found FDA's policies for auditing those third parties are missing basic details, including any time frame for completing an audit or telling the third party what it found. As a result, some recent audits that turned up deficiencies, like vague standard operating procedures, took FDA more than six months to close out.

GAO made one recommendation: set target time frames for audits and for communicating results. Health and Human Services concurred.

The full dispatch is available from the source below.

✒ FROM THE EDITORIAL DESK

An agency that oversees who gets to review medical devices couldn't manage to write down how long its own oversight should take. That's not a scandal, just a filing cabinet nobody bothered to organize for two decades. Good on HHS for agreeing to fix it, though you'd think a deadline for checking homework wouldn't need a government audit to invent.

Source: Read the original at GAO → Scored: Umbrella Pants · Kevin MacLeod · CC BY 4.0

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