AI in Medicine News ・ ⚖️ Device approvals and regulation

AI-enabled medical devices require an integrated FDA and IP strategy following draft guidance on pre-market submissions

IAM Media · 10/21 12:51 UTC

Following publication of an FDA discussion paper and draft guidance, medical device companies should prepare a cohesive patent and pre-market submission strategy. This involves considering FDA recommendations when developing AI-enabled features and coordinating statements made to the USPTO and the FDA.

Read the original (IAM Media)

See it in the digest → ・ See this issue →