US FDA's Software Pre-Cert Program: Is The Authority On The Books?
The agency is building its pre-certification program as a novel paradigm for health software products to reach the market with less scrutiny when companies successfully undergo "excellence" appraisals. It has attracted the interest and support of many stakeholders, but at least one medtech group argues the agency should have to get congressional approval to launch the program.
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Shuren: FDA Making ‘Pre-Cert Simulator’ To ‘Test Drive’ Regulatory Frameworks For Digital Health Tech
US FDA device center director Jeff Shuren said on 6 October that the agency is developing a “precertification simulator” that will allow it to assess different regulatory frameworks in the digital health space.
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.
Several experts suggest FDA is toeing the line in keeping the first stage of its pre-certification program for software-as-a-medical-device products legally permissible, but it may be limited in scope for the time being. Meanwhile, one attorney says the agency is sending mixed messages about whether the current program will sit comfortably within FDA's current authorities.