The Medpoint Blog

Learn best practices and gain new insights on quality assurance, regulatory strategy, and clinical affairs.

FDA Announces Changes to 510(k) Process

The last several years have brought many changes to the medical device quality and regulatory industries, and recent FDA announcements promise even more in the near future. As announced in late November 2018, there are significant updates planned for the 510(k) submission process, specifically related to the use of predicates.  Read More