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Are you ready to enter your medical device into the commercial marketplace? This course covers the specifics of regulatory submissions made to the FDA for the purpose of placing a medical device on the commercial market. Submissions covered will include: pre-submissions (pre-IDE and pre-510(k)); IDE; PMA; and 510(k). Additionally international submissions for CE mark will also be introduced.

This workshop style course will offer students an opportunity to practice understanding and gathering the complex scientific information required in various regulatory submissions. You will examine the process of writing medical device submissions for regulatory agencies, both nationally and internationally and will culminate with a preparation of a sample 510(k) submission.

Topics include:

  • Laws and regulations of medical devices
  • Device classifications
  • Product development process
  • Submission structure and content.

Practical Skill Development:

  • Understand medical device product classifications
  • Understand the premarket submission process, including 510(k), PMA and IDE
  • Introduce students to the international submissions required to obtain CE mark for medical devices.
  • Competently use the FDA website to find information for preparation of a FDA regulatory submission.
  • Understand all the sections of a 510(k) submission and how to gather the information required
  • Prepare a sample 510(k) submission for a medical device.

Note: Prerequisite: Overview of Regulatory Affairs for Medical Devices
–or-
Previous work experience

Course Number: BIOL-40325
Credit: 3.00 unit(s)
Related Certificate Programs: Regulatory Affairs for Medical Devices

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