24 янв. 2012 г.

FDA issues guidance on IDEs for knee cartilage repair/replacement devices and drugs

The FDA issues new guidance on proper submissions for investigational device exemption and investigational new drug applications for products intended to repair or replace knee cartilage.

The FDA this week issued new guidance on getting clearance for clinical trials of products intended to repair or replace knee cartilage.

The guidance covers devices, biologics and hybrid products, outlining required items to include in submission documents for investigation device exemption or investigation new drug applications.
The new guidance is the finalized form of a draft in the works since July 2007, and includes sections detailing clinical study schedules and non-clinical data considerations in response to comments the agency received during the draft process.

Required documents for IDEs include written descriptions of individual components, materials, anticipated changes to the device and evidence that instrument materials are safe for limited contact with a breached surface.

The agency also modified some of the language in the original document to be more consistent with other FDA recommendations on IDEs and INDs.

The document doesn't apply to prostheses such as total or unicondylar knee replacements, according to the guidance.

The FDA was met with a rather dramatic scene during the drafting of this guidance, resulting in the agency rescinding 510(k) clearance for former device maker ReGen Biologics' Menaflex knee implant in after concerns arose about its path to the U.S. marketplace.

The Menaflex 510(k) clearance in December 2008 came over the objections of FDA scientists who opposed clearing the device. In September 2009 the agency admitted that undue influence from 4 New Jersey congressmen and former commissioner Andrew von Eschenbach affected the decision to green-light the device and announced an investigation into the foofaraw.

In March 2010, the agency's Orthopedic & Rehabilitation Devices Panel decided that, while the implant is reasonably safe, its effectiveness needed to be further analyzed. That decision came the same week that the FDA released a report saying ReGen failed to produce adequate evidence that device was safe before it was cleared to hit the market.

In June 2011, after the FDA finalized the rescission, a bankrupt ReGen filed a lawsuit against the watchdog agency its top regulator and the secretary of the U.S. Dept. of Health & Human Services, accusing them of overstepping their bounds.

The new FDA guidance would not have applied to the Menaflex device, which was designed to repair torn knee meniscus cartilage.

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