Successful 510(k) Submissions

Instructor: John E Lincoln
Product ID: 700815
  • Duration: 90 Min
The 510(k) submission process is the preferred method for obtaining marketing clearance in the U.S.


The 510(k) submission process is the preferred method for obtaining marketing clearance for medical devices in the U.S.

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Last Recorded Date: Aug-2008

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Read Frequently Asked Questions

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: 1) Premarket Notification, 510(k), unless exempt; or 2) Premarket Approval (PMA), a much more involved, costly and time-consuming process. Where ever justified, the 510(k) submission process is the preferred method for obtaining marketing clearance in the U.S. How is this decision arrived at? If the 510(k) route is justified, what is involved? Sequence of events? What’s included? Desired format? The three types of 510(k)s and what’s involved in each. 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.
  • 510(k) determination - new; and substantially modified.
  • Three types of 510(k)s and which is justified.
  • The importance of the "Intended Use" statement.
  • How to locate predicate devices?
  • Choosing the predicate device(s) for the 510(k) - important considerations.
  • Risk Analysis; Software considerations / reporting.
  • What to include, what to hold in abeyance?
  • The 510(k) and the DHF files.

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 designed, written and run all types of qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 27 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

Follow us :
Risk Management in Medical Devices Industry
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations

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