Call Us: 1.800.873.5297

By

Medical Devices Lack Safety Evidence, according to Recent JAMA Study

The Wall Street Journal reports that a recent study reveals that the majority of FDA approved moderate- to high-risk medical devices lack publicly available scientific evidence regarding safety and efficacy.

According to a recent study published in JAMA Internal Medicine, researchers found that 42 out of 50 specific FDA approved medical devices lacked such data, despite a 1990 regulation calling for sufficient detail in order to justify FDA clearance. Dr. Diana Zuckerman, a study author and president of the National Center for Health Research, said, “If wonderful studies are being done, there is no evidence of this, and there’s no way for the public to see it. It’s shocking how little information is available despite an FDA leadership that talks about transparency.”

The 510(K) review is a type of medical device approval whereby approximately 400 medical devices are approved each year and cleared for marketing. Under this system, the device company is not required to conduct studies in human patients – although it may. Most devices are able to receive FDA clearance simply by showing that they are roughly equivalent to another product already on the market. The theory is essentially that if the older, similar device is proven to be safe and effective, then the newer one should be too. However, this 510(K) process has led to large-scale cases for thousands of injured individuals across the country, including a recent Multidistrict Litigation involving metal-on-metal hips manufactured by DePuy (In re: DePuy Orthopaedics Inc. ASR Hip Implant Products Liability Litigation, MDL 2197).

 

The choice of a lawyer is an important decision and should not be based solely on advertisements.

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.