Medmarc Blog (blog.medmarc.com)
Premarket Approval (PMA)
FDA Updates Patient Preference Guidance
A The FDA has released the final guidance on the use of patient preference information (PPI), an update of an earlier guidance. The new PPI guidance is applicable across the entire product life...
FDA Post-Approval Studies Guidance Applies Tighter Timelines
The new FDA final guidance for post-approval studies (PAS) accelerates some of the timelines in the previous version, and introduces some new deadlines to this policy. These changes are the same...
FDA Electromagnetic Compatibility Guidance Covers Investigational Devices
The FDA has released a final guidance for electromagnetic compatibility (EMC) for medical devices, a policy that applies to PMA, 510(k), and de novo devices. However, the scope of the guidance also...
FDA Released Finalized Guidance Document for Combination Products
In January 2022, FDA released a new final guidance document titled, ‘Principles of Premarket Pathways for Combination Products’ which has caused many manufacturers to reevaluate their FDA...
FDA’s Continued Efforts to Mitigate Drug Shortages is Facilitated by the Launch of the New NextGen Portal
The CARES Act, signed into law on March 27, 2021, is aimed at managing the COVID-19 crisis and moderating its economic impact. Section 3112 of the CARES Act enabled FDA to avoid drug shortages...
The MDCG’s New Guidance on Classification of Medical Devices
In October 2021, the Medical Device Coordination Group (MDCG) published a guidance to aid medical device manufacturers in complying with classification rules in the European Medical Device...
FDA Released New List of AI/ML-Enabled Medical Devices
In September 2021, FDA’s Digital Health Center of Excellence released a list of artificial intelligence/machine learning-based software as a medical device (“AI/ML-based SaMD”) that are marketed
FDA Issues Pandemic Policy for Supplements
The FDA and other agencies at the U.S. Dept. of Health and Human Services have taken a number of measures to push back against the COVID-19 pandemic, but an agency at the Dept. of Commerce is...