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FDA The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings.

  • 1.  FDA The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings.

    Posted Sep 26, 2022 09:54:00 AM
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    Hi All,

    The U.S. Food and Drug Administration (FDA) issued the report The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings. The Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence authored the report.

    The FDA launched the Software Precertification (Pre-Cert) Pilot Program ("the pilot") in 2017 to explore the possibility for innovative approaches to regulatory oversight of medical device software and advance the FDA's mission to protect and promote public health. The pilot explored innovative approaches to regulatory oversight of medical device software developed by organizations that have demonstrated a robust culture of quality and organizational excellence and who are committed to monitoring real-world performance of their products once they reach the U.S. market. With this report, the FDA is marking the completion of the Pre-Cert Pilot Program. Based on the observations from the pilot discussed in this report, the FDA has found that rapidly evolving technologies in the modern medical device landscape could benefit from a new regulatory paradigm, which would require a legislative change.

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    Michael Roza CPA, CISA, CIA, MBA, Exec MBA
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