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Medical Devices / Regulatory Affairs

FDA Calls for Comments on Strengthening Premarket Reviews

Jan. 28, 2019
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The FDA asked for stakeholder comment on its initiative to tighten up premarket reviews through modernization of its 510(k) program.

For example, the agency wants to know if it should release a public list of devices or manufacturers that use predicates that have been on the market for more than a certain number of years.

Additionally, the agency called for suggestions on alternative actions it could take promote the marketing and development of safer, more effective 510(k) devices.

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