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(ASCA) Program is designed to streamline the premarket approval process for medical devices and is detailed in a draft guidance released by the FDA on September 23, 2024.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,
Due to the novel coronavirus/SARS-CoV-2/COVID-19 rapid infection rate, as well the viruses ability to create asymptomatic carriers, resulting in major societal disruptions and shutdowns have occurred throughout the world, but nowhere has this pandemic hit hardest than within the health care systems, hospitals and clinics. Due to the enormous surge of critical care, there is a massive demand and shortage
