Navigation Links
FDA Acknowledges Mistakes in Knee-Device Approval
Date:9/24/2009

Agency says it will review procedure for endorsing medical devices

THURSDAY, Sept. 24 (HealthDay News) -- The U.S. Food and Drug Administration violated procedures last year when it approved a knee repair device even though its own scientists recommended against approval, agency officials said Thursday.

The device, called Menaflex, is made by New Jersey-based ReGen Biologics and is used to help surgically repair knee damage -- specifically, damage to the meniscus. But, a report released by the agency Thursday found that some FDA scientists had recommended against approval.

"There were numerous departures from processes, procedures and practices, and there were problems with the review process for the device," Dr. Joshua Sharfstein, the FDA's principal deputy commissioner, said during an afternoon teleconference.

In addition, the FDA report noted that four New Jersey Democratic lawmakers -- Senators Robert Menendez and Frank Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman -- made inquiries to agency officials about the device's approval status.

"Members of the delegation apparently had conversations with the [FDA] commissioner and at least one conversation with the [former] principal deputy commissioner," the report said.

Going forward, the FDA plans to review the process by which such medical devices are approved, Sharfstein said. "It will also include a reevaluation of the clearance of this device," he said.

However, there are no plans to remove the Menaflex device from the market, officials said.

"This device has been approved by the FDA, and we have no basis to question the safety of this device so it will remain on the market," Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said during the teleconference.

"What we have concluded is that the integrity of our process for reaching a decision was compromised in this case, so we are revisiting and evaluating the record and the bases for making that decision," he said.

Sharfstein said that consumers should not worry if they have a Menaflex device.

He also said the FDA is looking to refine a procedure that would mediate differences among agency personnel when approving medical devices.

On Wednesday, responding to criticism of its safety review record, the FDA asked the U.S. Institute of Medicine to examine the approval process for certain medical devices. Specifically, the institute will look at an approval process called a 510k review procedure. This allows companies to immediately introduce products similar to ones already on the market. Menaflex was approved under this process, according to the FDA.

The 510k process is supposed to speed up approval of medical devices such as wheelchairs and bandages, but it has also been used to approve devices such as heart implants and hip replacements.

More information

The U.S. Food and Drug Administration has more on medical device approval.



SOURCES: Sept. 24, 2009, teleconference with Joshua Sharfstein, M.D., principal deputy commissioner, U.S. Food and Drug Administration, and Jeffrey Shuren, M.D., acting director, Center for Devices and Radiological Health, FDA


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Frost & Sullivan Acknowledges Syntec Optics Unwavering Focus on Innovation and Strategies to Improve Profitability
2. Perrigo Acknowledges Settlement of NASACORT(R) AQ Nasal Spray Patent Litigation
3. Watson Acknowledges Federal Trade Commission Action Regarding AndroGel Patent Settlement
4. Frost & Sullivan Acknowledges Sypris for High-Quality Calibration Solutions
5. Physicians Want to Learn From Medical Mistakes But Say Current Error-Reporting Systems are Inadequate
6. Study Finds Doctors Not Reporting Medical Mistakes
7. Compulsive Gamblers Dont Learn From Their Mistakes
8. Infection Experts Report Reveals the CDCS Deadly Mistakes
9. Brain Patterns Predict Mistakes
10. Seven Mistakes to Avoid When Seeking Social Security Disability Benefits
11. The Five Biggest Marketing Mistakes Made By Medical Offices and Small Businesses
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is underway. ... transport experience for the millions of people who require these medical transport services ... industry through the use of technology. Now, SmartEMS has put forth an industry-changing ...
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... ... 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to a ... new, often overlooked aspect of head lice: the parasite’s ability to live away from a ... occurrence, but a necessary one in the event that lice have simply gotten out of ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- , , , WHEN: , ... , , , LOCATION: , , , Online, with free ... EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice President ... Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... is witnessing an exceptional era. Several new demand spaces, such as ...
(Date:6/23/2016)... , June 23, 2016  Guerbet announced today that ... Supplier Horizon Award . One of ... was recognized for its support of Premier members through ... clinical excellence, and commitment to lower costs. ... this recognition of our outstanding customer service from Premier," ...
(Date:6/23/2016)... NEW YORK , June 23, 2016 ... rough waters, but it continues to present great opportunities ... featured companies for today: Intrexon Corp. (NYSE: ... ), Arena Pharmaceuticals Inc. (NASDAQ: ARNA ), ... Learn more about these stocks and receive your complimentary ...
Breaking Medicine Technology: