Prime Path Medtech

FDA

Prime Path Medtech is a US medical device consulting firm offering regulatory, quality, clinical research and product-development services. Its regulatory team supports FDA 510(k), De Novo and PMA submissions, global market strategy, post-market compliance and change control. The firm also builds quality systems, manages clinical studies and provides fractional staffing for device companies that need hands-on execution without a full internal team.

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Are there FDA requirements for non-device clinical decision support software?

Anonymous · 1 comment

5 months ago

According to the new FDA guidance on clinical decision support software, our software is classified as a non-device. What are the requirements for bringing such software to the US market? Are there st

Accepted 1 answer

If your assessment shows that your product is truly a “non-device” according to the FDA guidance, there aren’t specific FDA requirements you need to m

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Post Market Clinical Follow-up: The Report (Medical Device Clinical Evaluation)

Dr. Oliver Eidel

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Clinical Evaluation: Post-Market Surveillance (PMS) Database Search

Dr. Oliver Eidel

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