Lexology December 16, 2022
In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program. The new FDA policies move away from prized flexibilities in the previous guidelines governing software products. In the new and final CDS Guidance, FDA modified its interpretation of each of the four criteria in section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act, significantly narrowing what FDA considers exempt from regulatory authority. FDA also released its report, Digital Health Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings, detailing the results of the pilot program and ultimately shutting down the initiative. FDA originally envisioned the precertification program...
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