New FDA Proposed Rule will Impact Regenerative Medicine Products

For those involved in creating regenerative medicine products that combine cells with various biomaterials, such as natural or synthetic scaffolds, you should be aware that the FDA recently issued a new Proposed Rule for these types of medical products.  In regulatory speak these are “combination products” since each component can be regulated separately.  For example, cells are regulated as biological products and most scaffolds are regulated as medical devices. So a regenerative medicine product consisting of cells and scaffolds is defined by the FDA as a biologic-device combination product.

The new Proposed Rule describes in somewhat confusing detail when the drug-biologic good manufacturing practice (GMPs) will apply to these products versus the medical device quality systems regulations (QSRs).  In a nutshell, the manufacturer of a combination product can decide to either adopt QSR regulations or adopt GMP regulations for the manufacturing or choose a hybrid approach.  Here are the 3 main choices i gleaned from my quick read of the rule:

  1. If you already have a quality system based on the medical device QSR regulations you can continue to use this system.  However, you may need to augment your quality system to include some GMP specific requirements.
  2. If your firm already has a quality program based on the GMPs, you can continue using the GMPs, but may need to augment some elements of the medical device QSRs that are missing.
  3. The alternative either of those approaches is to apply medical device QSRs to only the medical device component and GMPs for the biologic component.  For example, if your regenerative medicine product consists of ex vivo expanded cells that are seeded onto a synthetic scaffold, one could envision a hybrid quality program that ensures the cells (biological product) are manufacturing according to GMPs and the scaffold would be manufactured according to medical device QSRs.

One issue that is not entirely clear, particularly for a regenerative medicine product, is how the designation of a “Lead” FDA Center will influence the choice in the quality approach that is most appropriate.  The “Lead” FDA Center is the group that will review and ultimately approve the medical product.  While there are a lot of similarities between QSRs and GMPs, I’m not sure I would want to choose the QSRs if my combination product is going to be reviewed by CBER, which is more familiar with the GMPs.  Similarly, choosing the GMPs for a combination product that is reviewed by medical device reviewers in CDRH, would probably not be a wise decision.

Like any new proposed rule, I am sure there will be a number of comments from stakeholders in industry and academia. If you want to make a comment on this proposed rule, here is the link to do so online.  Comments are due by 22-December 2009.



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