DePuy Suspends Custom Devices Following FDA Warning
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Daniel Riordan-driordan@timesuniononline.com
DePuy addressed a warning letter it received from the Food and Drug Administration and has decided to suspend providing custom devices.
The warning letter from the FDA was issued Dec. 8 to Mary E. Riggs, worldwide vice president of finance for DePuy.
The letter stated that during an inspection of the Warsaw-based orthopedic company from May 10 through June 7, the FDA determined that some DePuy products didn’t have proper premarket approval by the federal agency.
The letter lists 14 DePuy devices that “have no premarket clearance or approval, or have been modified in ways that could impact the safety and effectiveness of the devices.”
Devices included in the letter are PFC Sigma Knee System, Agility Total Ankle Prosthesis and TriFlange Acetabular Cups.
The FDA notes that DePuy distributed the products without approval or clearance because the company was under the belief that they are custom devices.
In a statement released by DePuy Wednesday evening, the company said it believes it was in compliance with FDA requirements.
“DePuy Orthopaedics Inc. received a warning letter dated Dec. 8, 2011, from the U.S. Food and Drug Administration stipulating that certain custom medical devices provided by DePuy did not meet the FDA’s definition of custom devices and were being sold without the proper clearance/approval,” according to the statement. “Custom medical devices, which are provided at a physician’s request to meet a specific patient need, have been an allowed exemption to FDA premarket review under the Food, Drug, and Cosmetic Act since 1976.”
The company said that while it believes it met FDA requirements, DePuy has made the decision not to provide custom devices at this time.
The letter guided DePuy to take prompt action, citing that if it didn’t the company could face such penalties as fines, injunction and product seizures.
Request for an interview from an FDA representative from the Times-Union weren’t returned as of press time today.
The letter also cited concerns regarding DePuy’s efforts to improve compliance with various quality system regulation requirements following a June inspection.
The letter said DePuy didn’t have proper procedures in place to ensure products fit to a user’s needs.
DePuy said it has implemented a number of actions to address concerns raised in the inspection, and has responded to all concerns raised in the warning letter.
