FDA publishes Draft Guidance on Clinical Studies for Medical Devices

At the end of 2011 the FDA published 2 draft guidance documents entitled "FDA Decision for Investigational Device Exemption (IDE) Clinical Investigations" and "Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies" on clinical studies for medical devices. In addition to that, the FDA announced a pilot programme for the latter draft guidance. The programme should support the acquisition of experience regarding "fewer Non-Clinical Data" and facilitating real-time changes on medical devices and on clinical documentation at early steps of the feasibility studies. Approaches for that are detailed in the draft guidance.

The draft guidance "FDA Decision for Investigational Device Exemption (IDE) Clinical Investigations" is addressed to "Clinical Investigators", "Institutional Review Boards" and FDA staff. The document describes how - under certain conditions - clinical studies under FDA´s "Investigational Device Exemption" (IDE) may be possible even if not all the prerequisites for IDE are met.

Read more in the respective Federal Register announcements:

• Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations
• Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies

The Federal Register also comprises details about the pilot programme.

Here you can access the draft guidance "FDA Decision for Investigational Device Exemption (IDE) Clinical Investigations" and the "Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies".

Compiled by
Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)