Digital Health Software Precertification (PreCert) Program
FDA reimagining oversight of digital health technology
- timely access to high-quality, safe, and effective digital health products
- Digital Health efforts outlined in Digital Health Innovation Action Plan
“Software Precertification (PreCert) Pilot Program.” – new pilot program
- looking first at the software developer and/or digital health technology developer, rather than primarily at the product
Goals
- modern approach to software iterations and changes
- high quality medical product software throughout the life of the product
- adjust key elements and measure based on program effectiveness
Image Credit: FDA
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