FDA requirements, U.S. medical device regulation, submissions, compliance, and market access.
FDA has proposed electronic submission standards for IDE applications. Learn what the draft covers, the proposed transition period, and how sponsors can prepare.
FDA has highlighted resources on Predetermined Change Control Plans. Learn how PCCPs can support planned device updates and what manufacturers should consider before developing one.
FDA FY 2027 medical device fees are now effective. Review key submission costs, small business eligibility, and regulatory planning considerations.
Understand when FDA UDI requirements apply to medical devices, including device identifiers, GUDID, direct marking, exceptions, and key considerations for the U.S. market.
