CONTEXT: Opinion piece on the developing FDA guidance and legislation to come on medical devices. This I going to be especially interesting for SaaMDs and AI in medical devices.
IMPACT: Medium
READ TIME: 5 mins
Quality Level Mean [1 – 10]: 7
1. “For years, FDA has talked about aligning its Quality System Regulation (QSR, 21 C.F.R. § 820) with the international medical device quality system, ISO 13485, which is used by many other countries.”
2. “The four focus areas selected for this year are:. While all of these focus areas affect medical devices, the data one is most relevant to medical devices, because of its sub-focus areas: Product Safety Surveillance, Artificial Intelligence, Digital Health, and Use of Real-World Evidence to Support Medical Product Development and Regulatory Decision-Making.”
3. “Fu has told medical device manufacturers that they will see a new FDA cybersecurity draft guidance this year.”
4. “In January 2021, FDA issued its Action Plan for Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD), building on its April 2019 Proposed Regulatory Framework for Modifications to AI/ML-Based SaMD.”
5. “In the digital health field, FDA is expected to continue its efforts to improve the review and availability of digital health medical products, including better coordination between FDA’s drug and device centers.”
Source URL: https://www.jdsupra.com/legalnews/a-look-ahead-us-fda-and-medical-device-1111702/