FDA Issues Two Draft Guidance Documents Related to Investigational Device Exemptions: Agency Also Announces Pilot Program for IDEs for Early Feasibility Studies


On November 10, 2011, the Food and Drug Administration (FDA or the Agency) issued two draft guidance documents: Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Studies, Including Certain First in Human (FIH) Studies, and FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations. The Agency also announced a small pilot program for implementation of the early feasibility study IDE draft guidance. Comments on the draft guidance documents must be submitted by February 8, 2012. FDA will begin accepting applications for the pilot program on December 12, 2011.

Early Feasibility Study IDE Draft Guidance

The early feasibility study draft guidance distinguishes early feasibility studies from traditional feasibility studies and pivotal studies. An early feasibility study is conducted using a medical device that is still in an early stage of development to generate data regarding the device’s design concept with respect to basic safety and device functionality. On the other hand, a traditional feasibility study is usually conducted using a near-final or final device to obtain preliminary safety and effectiveness information.v Both types of feasibility studies differ from a pivotal study, which is intended to collect definitive evidence of safety and efficacy sufficient to support a marketing application.

Please see full article below for further information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© King & Spalding | Attorney Advertising

Written by:


King & Spalding on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.