Medical Devices

Still waiting on FDA to approve medical device identifiers (big sigh)

FDA logoWhile the FDA promised decisions on unique identifiers by the end of June, according to Modern Healthcare, it’s still under “administrative review.”

The FDA has received an open letter to the Office of Management and Budget urging them to push the regulations through and to shorten its proposed seven-year time frame from the Advancing Patient Safety Coalition. In an odd marriage, The Pew Charitable Trusts and Premier healthcare alliance also sent an open letter, emphasizing a “prompt” complete review. Both letters were sent last week.

According to Modern Healthcare:

“Congress passed a 2007 law first mandating the development of the unique-device identification system. A law passed last year required the final rule to be released within six months of the closing of the comment period for the proposed rule.

The FDA has proposed a risk-based approach to the roll-out of the UDI system, starting with the packaging of high-risk medical devices and eventually including low-risk devices over a seven-year period.”

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