FDA SAMD Clinical Evaluation Final Guidance

On Dec. 8, 2017, the FDA released the final guidance, “Software as a Medical Device (SAMD): Clinical Evaluation.” The October 14, 2016, draft is now obsolete. This guidance is actually the use of an International Medical Device Regulators Forum (IMDRF) document completed in June of 2017, so this represents broad international consensus. This guidance discusses various types of clinical evidence to support safety and effectiveness of a wide range of software devices. Information is provided on the FDA’s perspective on use of pre-existing scientific and clinical information, analytical evaluation, and bench testing. It also distinguishes between expectations for well-established clinical associations vs. novel clinical associations. Section 9.0 discusses Continuous Leveraging of Real World Performance Data to support additional performance claims and functions or to reduce such claims. The full guidance is at the link provided. PDF Copy of FDA Guidance

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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