Remember the ruckus about Menaflex Collagen Scaffold, manufactured by ReGen Biologics, 510(k) cleared in December 2008 for repair and reinforcement of meniscal tissue in knees? Remember the 2009 internal FDA report lambasting old FDA management and the perceived political pressure from some members of Congress? Some people think it was all this that started the 510(k) re-evaluation process FDA is now undertaking.

On October 14, 2010, FDA announced that after taking another look at the scientific evidence supporting the 510(k), it had decided the 510(k) shouldn't have been cleared after all. According to the agency's letter to the company and its decision memorandum, FDA has now concluded that the Menaflex device is intended for different purposes and is technologically dissimilar from identified predicate devices. The agency states that these differences can affect the safety and effectiveness of the Menaflex device. For example, according to the agency, instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace tissue that was surgically removed.

Interestingly, the company has stated that the product has been used in Europe for 10 years with no reported safety issues.

For administrative law reasons, FDA explicitly stated that this is not a "final agency action" (which would give the company the ability to seek judicial relief). Rather, FDA described this as an initial step and has asked ReGen Biologics to meet with it to discuss the appropriate marketing pathway for the product.

This development is significant for many reasons:

1. If you've had a chance to read the review history of Menaflex, you know how strongly some CDRH reviewers believed the 510(k) was not clearable. This decision to rescind the 510(k) will be enormously vindicating and empowering to those reviewers and others who believe NO is the right answer.

2. And what about rescinding a 510(k)? Can they do that? Well sure, the agency must be legally able to correct its mistakes, but the fact is, the agency hasn't rescinded a 510(k) very often, and not in a long time. FDA's actions may well be triggering protracted and complex administrative law issues. The fact that any 510(k) is being rescinded is significant in itself.

3. This is a fantastic opportunity to gain some insight into how the agency is currently thinking about knotty 510(k) issues. It seems clear from this case that FDA is taking a much narrower view of what is a predicate, what is new technology and what might be new questions of safety and efficacy. The center director signed a 21-page memorandum explaining the decision. In this memorandum, the current director of CDRH criticized and reversed the decision of his predecessor and the prior head of ODE. This memorandum also discounts prior panel meetings finding the device to be safe. In this decision, CDRH took a narrow and limited view of what constitutes a valid predicate device. In making this determination, CDRH considered uses of the device outside of the labeled indications for use (apparently off-label uses or statements).

4. Even more fundamentally, this is an opportunity to gain insight into what kinds of products are considered devices at all. As we know, the Food, Drug and Cosmetic Act says that a device cannot "achieve its primary intended purposes through chemical action within or on the body of man…."[1] Stimulating the growth of new tissue sounds like it could be chemical action. The claims permitted going forward for this product will provide great insight into the agency's interpretation of the statutory definition of a device.

5. This case also demonstrates the agency's dislike of any "political pressure." The fact that four Democratic Senators and Representatives from New Jersey (the home state of ReGen) contacted FDA regarding the status of this submission upset the reviewers and contributed to the politicalization of this submission.

Conclusion: In an effort to minimize criticism and concerns, FDA is reporting positioning this as a unique situation. Regardless, several lessons seem clear:

  • CDRH is taking a narrower view of what constitutes a predicate. This means more devices will need to go through the PMA process.
  • CDRH is taking a narrow view of what is a similar technology or similar safety or efficacy question – again pushing more devices into the PMA route.
  • Individual review power has been enhanced.
  • Using the political process to push a product through FDA is a high-risk strategy.

FDA's press release on the rescission of the Menaflex 510(k) is available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229384.htm.

FDA's letter to ReGen Biologics is available by clicking here.