FDA Draft Guidance on Device “Product Enhancements” Could Lead to Increased Recalls


On February 22, 2013, the Food and Drug Administration (“FDA”) issued draft guidance explaining when a change to a medical device constitutes a medical device recall as opposed to a “product enhancement.” This draft guidance has the potential to increase the number and frequency of recalls. Device manufacturers should pay close attention to FDA’s proposed changes in this area, as litigation and government investigations alleging violations of recall-related regulations have been increasing.

Newly Created Term – “Product Enhancement” -

FDA regulations define a recall as the “removal or correction of a marketed product that [FDA] considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.” 21 C.F.R. § 7.3(g). The term “product enhancement” does not appear in FDA regulations, but is defined in the draft guidance to mean a change to improve the performance or quality of a device that does not remedy a violation of the Food, Drug, & Cosmetic Act (“FDCA”).

The draft guidance sets forth a decision-making flow chart for distinguishing medical device recalls from product enhancements by asking such questions as...

Please see full alert below for more information.

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

Written by:

Published In:


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.

© Ropes & Gray LLP | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* 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.