Aug 3 2022 The 513(g) Request is for the medical device manufacturers who submitting, reviewing, and responding to classify particular...

July 22 2022 On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label...

July 12 2022 Q-Submission offers important opportunities for you to share information with FDA and receive input outside of the...

Jun 29 2022 The MDR regulation provides a mechanism that allows the FDA to identify and monitor adverse events such as deaths and serious...

Jun 23 2022 Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic...

Jun 22 2022 Step 1 Device Discovery and Concept Medical device development follows a well-established path. Many of these steps overlap...

Jun 21 2022 Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable...

Jun 20 2022 In accordance with section 513(f)(2) of the FD&C Act, you may submit a De Novo request for FDA to make a classification...

Jun 17 2022 The United States (U.S.) Food and Drug Administration (FDA) is responsible for ensuring that medical devices (including in...

Jun 16 2022 The Food and Drug Administration (FDA) is issuing this guidance to provide recommendations for manufacturers about the...