The Association of Clinical Research Professionals

US FDA Submission Process for Medical Devices

Regulatory submissions are a result of teamwork, often occurring over many years. Each person involved in the testing, organization, or clinical studies is integral to the success of the submission. This session will take a step by step approach to walk attendees though what is required in the 510(k) and PMA submission process; and how you can best support the process. In order to commercialize, additional FDA establishment registration and device listings are required; these registration/listings help the FDA plan facility inspections. Participants of this session will get a broad appreciation of the submission process and some best practices to support your team in the regulatory submission process.


This program is a recorded session from ACRP 2019