USA – US FDA presents premarket submissions pilot program and patient-centered data resource pages

The US FDA’s Center for Devices and Radiological Health (CDRH) has introduced a new pilot program for a different method of electronic premarket submissions pertaining to medical devices, and it has published resource pages for manufacturers and stakeholders interested in incorporating patient-centered data sources into their decision-making processes.

New pilot program will test the suitability of Box software for premarket submissions

The CDRH announced the launch of the Electronic Delivery of Premarket Submissions Pilot, which provides an optional alternative method for medical device premarket submissions during the COVID-19 health emergency. According to the announcement, which is structured as a series of questions and answers, the Pilot will last for 90 days and is designed to test the CDRH’s capability to receive premarket submissions using the cloud-based filesharing service Box…