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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.
Angela Mallery, EdD
Principal Product Development Strategist
*THIS EVENT IS A REPLAY OF A PRESENTATION FROM THE 2019 GLOBAL CONFERENCE AND IS REMOTE ACCESS ONLY.
Please note: This is a replay of an ACRP2019 Conference Session.