U. S. FDA Medical Device Approval Process


Instructor: John E Lincoln
Product ID: 700863

  • Duration: 60 Min
Where ever justified, the 510(k) submission process is the preferred method for obtaining marketing clearance in the U.S.


In order to market a medical device in the U.S., manufacturers, foreign or domestic, must go through one of two evaluation processes by the U. S. FDA: Class 1 - exempt; Class II - Premarket Notification, 510(k); or Class III - Premarket Approval (PMA), a much more involved, costly and time-consuming process.

Last Recorded Date: Apr-2008


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Read Frequently Asked Questions

Where ever justified, the 510(k) submission process is the preferred method for obtaining marketing clearance in the U.S. How are such decisions arrived at? Differences from the EU MDD Annex IX schema. What is involved? Sequence of events? FDA expectations. What’s included? Desired format? Expected time frames and the post-submission review process "give-and-take".

Areas Covered in the seminar:

  • U.S. FDA Class I, II, and III products.
  • Similarities / differences with the EU MDD Annex IX Rules.
  • The importance of the “Intended Use” statement.
  • How to locate and choose predicate devices.
  • Exempt, 510(k), and PMA device categories.
  • Using the Code of Federal Regulations.
  • Risk Analysis; Software considerations / reporting.
  • Design Control, Change Control, and DHF files.
  • Cumulative changes; sale to product / IP to another company; follow-up actions.

Who will benefit:

  • Senior Management
  • New product project leaders / team members
  • Regulatory affairs
  • Quality systems personnel
  • R&D and engineering staff
  • All charged with new product development, risk analysis / management, regulatory submissions, and validations

Instructor Profile

John E. Lincoln,Consultant, has successfully developed and implemented and trained to device, pharma, medical gases, and dietary supplements CGMP-compliant systems. He has conducted compliance audits in all these areas. His systems have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development projects; with over 25 years of experience, in FDA-regulated industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP Compliance, and Intermountain Biomedical Association); he publishes a newsletter. He is a graduate of UCLA.

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