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Testing The Limits: Software De Novo, 510(k) Volunteers Wanted By US FDA

As the US Food and Drug Administration is developing a new pathway for certain medical software called the precertification program, the agency is asking de novo and 510(k) sponsors to volunteer for a test plan to help the agency in its efforts. At least one expert on the subject is skeptical and says the plan adds burdens without real benefits for sponsors.

Female hand with smartwatch and health application icons nearby. - Image

US Food and Drug Administration is asking de novo and 510(k) sponsors with medical software products to consider being test subjects for the agency's upcoming new precertification (pre-cert) pathway for certain digital health products.

On 22 May, the FDA put out a call to developers of software as a medical device (SaMD) who plan to submit a 510(k) or de novo application this...

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