16/17 November 2021
At the end of 2013, the FDA released the final version of the Guidance for Industry and FDA-Staff on "Investigation Device Exemptions (IDEs) for Early Feasibility Medical Devices Clinical Studies Including Certain First in Human (FIH) Studies". This is the final version of a draft from November 2011.
In total, the document contains 40 pages: 28 pages are actual Guidance text, and the remaining 12 pages are divided into 4 appendices. The Guidance explicitly addresses FDA employees, clinicians, "innovators", and industry using IDEs. The focus is primarily on studies with significant risk devices (according to 21 CFR 812 (m)) including - for example - certain implants. It is expressly referred to a benefit-risk analysis and protection measures for the patient.
Essential elements for the application and authorisation of an IDE are among other things a development strategy for medical devices as basis for the data to be collected in early feasibility studies. Reports of prior investigations, clinical plant and risk reduction strategies are further elements.
The 4 appendices of this guidance are particularly interesting:
1. Recommended topics for a Pre-Sub for an early feasibility study IDE
2. Device evaluation strategy example
3. Supplemental guidance for the preparation of an early feasibility study informed consent document
4. Device iteration example
Section 6.3 of the Guidance text already presents a table for an appropriate strategy (see also Annex 2).
Conclusion: The 40-page Guidance is very extensive and provides - fortunately - concrete support thanks to (hypothetical) practical examples in the form of 4 annexes.