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.
Brazil’s ANVISA is now one of only 12 regulatory authorities worldwide on WHO’s new list for medical devices — alongside the FDA. Here’s what the designation does and doesn’t mean for US manufacturers considering the Brazilian market.
Understand when FDA UDI requirements apply to medical devices, including device identifiers, GUDID, direct marking, exceptions, and key considerations for the U.S. market.
A practical overview of the key differences between FDA and ANVISA medical device regulation, including classification, submission pathways, quality requirements, and strategic considerations for manufacturers.
