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ACRP 2019 OnDemand


128 - US FDA Submission Process for Medical Devices


Apr 13, 2019 4:30pm ‐ Apr 13, 2019 5:30pm


Credits: None available.

Non Member: $75.00
Members: $15.00

Description

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.

Learning Objectives:

  • Characterize the steps in the submission process.
  • Discuss the Device Establishment Registration & Medical Device Listing as defined in 21 CFR Part 807.
  • Define the timeline that needs to be followed to register a device and the steps a foreign company needs to follow to register and appoint a US Agent.

Speaker(s):

Credits Available


US FDA Submission Process for Medical Devices Exam

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