The IDE (Investigational Device Exemption) - It's Purpose and Preparation

Instructor: John E Lincoln
Product ID: 701087
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Nov-2008

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Read Frequently Asked Questions

This IDE (Investigational Device Exemption) webinar will cover its purpose and preparation recommended subject headings and content Submission and follow up Usage in the clinical trial(s).

The U.S. FDA requires an IDE (Investigational Device Exemption) to be developed for any new product that is to be involved in clinical trials. This affects not just FDA Class III PMA devices, but increasingly many FDA Class II devices subject to 510(k) Premarket notification and clearance.

Areas Covered in the seminar:

  • The purpose of the IDE (Investigational Device Exemption).
  • Expectations of the FDA.
  • Its preparation -- recommended subject headings and content Submission and follow up Usage in the clinical trial(s) -- The IRB and "Informed Consent".
  • What you can and can’t do with product prototypes and their labeling Use in a follow-on 510(k).

Who will benefit:

  • Sr Management
  • R&D
  • Engineering
  • Marketing
  • QA / RA
  • Clinical trial administrators / monitors

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

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