MD&M East

Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come

For a medical device to be marketed in the United States, it must go through a regulatory process outlined by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and enforced by FDA. 1 For most ...
Forbes

Controversial IOM Report Highly Critical of 510(k) Process

The Institute of Medicine (IOM) has released a report highly critical of the FDA's 510(k) medical device clearance process and called on the FDA to develop "a new framework that used both premarket ...
National Academies of Sciences%2c Engineering%2c and Medicine

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

To gain a foundation on which to build its discussions, the committee commissioned two former Center for Devices and Radiological Health (CDRH) staff to draft a background paper on the 510(k) or ...