Katrina’s Blog™

It may seem as if a negative decision on your device application is final; however, that is far from the truth. CDRH has multiple processes for resolving disputes with any external stakeholders (sponsor, industry, or public) which are included in the applicable...

The materials used in medical devices, particularly those which are designed to be implantable or used in invasive procedures, must be carefully evaluated for safety and that evaluation documented in the premarket submission for the device. Some materials present...

We’ve already seen several updates on the FDA’s activities to modernize their operations, including updates to the web site structure and format, the April announcement of the CDRH reorganization (see this post), and a new CDER web page for FDA-Track (see this post)....

Under the FDA Reauthorization Act of 2017, the FDA received a mandate to promote practices that lead to clinical trials better reflecting the population most likely to use the drug. Based on discussions at a public meeting held in April 2018, CDER’s Office of Medical...

Have you been wondering how to start planning the regulatory process for your proposed medical device? CDRH offers this web page showing the 5 steps of how to study and market your device, and it’s an ideal first step for the new device sponsor. It shows the 5 steps...