The IDE (Investigational Device Exemption) - It's Purpose and Preparation
Instructor:
John E Lincoln
Product ID: 701087
- Duration: 60 Min
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
More Training By Experts
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- Validation for FDA and ISO 13485 Compliance: Pack of Two Courses
- Medical Device QSR (21 CFR Part 820), Design Control, Hazard Analysis Under ISO 14971 and ICH Q9: Pack of 3 Courses
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