FDA reports problems with a recent 510(k) clearance process

Sen. Charles E. Grassley requested to see information about a collagen scaffold’s review.

A preliminary report issued by the FDA found from a review of internal processes surrounding the December 2008 510(k) clearance of a collagen meniscus implant that numerous agency actions were departures from accepted processes, procedures and practices at the time.

Those problems, which occurred during the agency’s review of the Menaflex collagen meniscal scaffold, made by ReGen Biologics Inc., were identified in the report dated Sept. 24 and outlined in an addendum to it.

The Menaflex implant, which is indicated for reinforcing and repairing chronic soft tissue meniscal injuries, was reviewed without clearance in two previous 510(k)s.

Recommendations

At a media briefing held after the report was released, FDA Principal Deputy Commissioner Joshua M. Sharfstein stated there were problems with the integrity of the product’s review process, according to a transcript of the briefing.

“[The report] makes a series of recommendations, all of which will be adopted. And those include review of the 510(k) process, which we announced yesterday would be conducted by the Institute of Medicine,” Sharfstein said in the transcript.

Gerald E. “Gary” Bisbee Jr., PhD, chairman, president and CEO of ReGen, said in a ReGen press release dated September 25 the FDA indicated in a phone conversation the review was only a procedural assessment.

ReGen input

“The FDA did not consider or re-evaluate the scientific evidence demonstrating the safety and efficacy of Menaflex, and our product’s performance was not the focus of its review. The FDA will conduct a separate re-evaluation of the scientific basis of the clearance, but has not yet determined the exact process by which such an evaluation will be made,” Bisbee stated in the release.

“ReGen stands behind Menaflex and believes that the scientific evidence for its collagen scaffold is solid,” he noted.

Clarifying information

This summer, when FDA was in the midst of conducting its review of the Menaflex device’s clearance, ReGen Senior Vice President, Regulatory, Clinical and Quality John Dichiara told Orthopedics Today ReGen conveyed key facts to Sharfstein in their own June 10 letter sent to him before the review began. The intent was to clarify information about the product’s clearance, clinical data and regulatory history, he said.

“We are confident in the data — in what information was provided and that the process was much more robust than most 510(k) reviews,” Dichiara said.

ReGen plans to continue marketing Menaflex in Europe and a U.S. launch, including surgeon training.

“We feel this is a great product. It provides an option for patients to get back some of the tissue that would be lost after partial meniscectomy surgery. There is little downside to [it] and a significant upside with an average gain of 70% more tissue than with partial meniscectomy alone,” according to Dichiara.

Grassley’s inquiry

Earlier this year Sen. Charles E. Grassley (R-Iowa), ranking member of the Senate Finance Committee, urged then acting FDA Commissioner Sharfstein to conduct the investigation into the process to clear the collagen meniscal scaffold. Sharfstein agreed to do so, according to a letter Grassley received from him on May 8.

“Your questions and the controversy surrounding this matter raise legitimate concerns about whether the agency’s review process and decision to clear for marketing the ReGen Collagen Scaffold were compromised,” Sharfstein wrote to Grassley.

In question were various actions related to how the FDA cleared the Menaflex scaffold, including whether N.J. politicians influenced how the FDA approached the product’s review and whether full scientific review of device was conducted, according to the agency’s report.

The FDA has commissioned the Institute of Medicine to study the current 510(k) premarket notification approval protocol.

For more information:

• John Dichiara can be reached at ReGen Biologics, 411 Hackensack Ave., Hackensack, NJ 07601; 201-651-3505; e-mail: jdichiara@regenbio.com. He is an employee of ReGen Biologics.

References:

• The FDA report can be found at http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm183745.htm.
• Grassley asks for an accounting of contacts between FDA and device maker. http://www.finance.senate.gov/press/Gpress/2009/prg030609d.pdf. Accessed July 10, 2009.
• Mundy A, Favole JA. Committee spars over medical device industry witness. Wall Street Journal. June 17, 2009. Accessed July 15, 2009.
• Sharfstein JM. Letter to Sen. Charles E. Grassley regarding FDA investigation into activities related ReGen Collagen Scaffold approval. Silver Spring, MD, May 8, 2009.