Is Grandfathering of Medical Devices Bad for Your Health?

Patrick Malone & Associates P.C. | DC Injury Lawyers
Contact

The vast majority of medical devices recalled by the U.S. Food and Drug Administration (FDA) were subject to a less stringent regulatory process that requires only that the device prove that it's similar to something already on the market, according to a recently published study.

Of the 113 devices recalled from 2005 to 2009 because the FDA determined they could cause serious health problems or death, 80 (71%) were reviewed using the “510(k) process,” which is meant to assess devices deemed to involve low or moderate risk.

Please see full publication below for more 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.

© Patrick Malone & Associates P.C. | DC Injury Lawyers | Attorney Advertising

Written by:

Patrick Malone & Associates P.C. | DC Injury Lawyers
Contact
more
less

Patrick Malone & Associates P.C. | DC Injury Lawyers on:

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:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide