Recently, FDA authorized and kicked off a new accreditation program bringing to the medical device industry a new option for medical device testing. The FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program is designed to streamline the premarket approval process for medical devices and is detailed in a draft guidance released by the FDA on September 23, 2024. The ASCA
In September of 2018, the FDA took their first step to improve and modernize the process of a 510(k) electronic submission. This commitment was established as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) that was enacted on July 9, 2012, amending the FD&C Act by adding section 745A. As part of this Act, a program
In late 2019, the FDA introduced a new Safety and Performance Based Pathway which can potentially speed up the preparation and review process for certain submitters of pre-market notification medical device submissions. This optional pathway was created by the FDA to assist with well understood device types, in which a submitter references device specific guidance’s detailing the appropriate testing standards,
