Stay updated with breaking news from Predicate Device. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics.
The FDA recently released three draft guidance documents that aim to "modernize" the 510(k) premarket notification process. This process permits medical device manufacturers to market...
Delaware Supreme Court Rejects No-Injury Medical Monitoring Claims - As part of our ongoing coverage of issues in Medical Monitoring, we noted that the Delaware Supreme...
On September 6, 2023, the FDA released three draft guidance documents that seek to "modernize" the 510(k) premarket notification process. Ever since the FDA first proposed "transformative...
On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more...