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Senators Await FDA’s Answers on Fast Device Review Proposal

July 15, 2019, 9:27 AM

The FDA needs Congress’ blessing to move forward with a proposal to allow faster approval of innovative medical devices, but two top Senate Democrats aren’t budging without answers.

The Food and Drug Administration hoped to streamline its approval process for devices used in life-threatening conditions that address an unmet medical need, shrinking it to a two-step review and temporarily allowing them onto the market with limited safety and effectiveness testing, according to its budget justification released in March.

These devices would usually qualify for the FDA’s review process for low-to-moderate risk devices, but the progressive approval process would let the...

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