📰 Product Development Protocol News
Product Development Protocol News Today
Fast, Ad-Free News Updates
Stay updated with breaking news from Product Development Protocol. Real-time updates on events, politics, business and more.
June 2, 2023
(May 30, 2023) Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B to ...
April 25, 2023
On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration ("FDA") issued a series of FAQs[1] and a guidance document[2] clarifying the agency's intended...
April 12, 2023
On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration (“FDA”) issued a series of FAQs and a guidance document clarifying the agency’s intended implementation of the...
April 11, 2023
Guidance documents from FDA clarifying agency implementation of Consolidated Appropriations Act that amended Section 524B of the Food Drug and Cosmetics Act to require the demonstration of cybersecurity safeguards in pre market submissions for certain medical devices.