FDA has determined that several products containing human demineralized bone matrix (DBM) combined with other components (sodium hyaluronate, glycerol, or calcium phosphate) intended to make DBM easier to handle by turning it into a putty or paste do not qualify for regulation solely under section 361 of the Public Health Service Act. These products are placed in bone voids or defects. They are regulated under the device provisions of the Federal Food, Drug, and Cosmetic Act.
On January 19, 2001, FDA issued a final rule called Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing1 which lists four criteria that must be met for human cells, tissues, and cellular and tissue-based products (HCT/P’s) to be regulated solely under section 361 of the Public Health Service Act.2 Regulation solely under section 361 would require establishments to adhere to regulations designed to prevent the transmission of communicable disease, but would not require premarket review or notification for such products. The criteria for regulation solely under section 361 are:
- The HCT/P is minimally manipulated;
- The HCT/P is intended for homologous use only;
- The manufacture of the HCT/P does not involve the combination of the cell or tissue component with a drug or device, except for a sterilizing, preserving, or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the HCT/P3 ; and
- The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
- The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
- is for autologous use
- is for allogeneic use in a first or second degree relative; or
- is for reproductive use.
Demineralized bone matrix alone (i.e., not combined with any other component) meets the criteria listed above for regulation solely under section 361. For the other DBM products considered, FDA has determined that certain components added to DBM products, such as sodium hyaluronate, glycerol, or calcium phosphate, are not sterilizing, preserving, or storage agents. These components meet the definition of a device because they are intended to affect the structure or function of the body by assisting in the filling of bone voids, and they do not achieve their primary intended purposes through chemical or metabolic action. Therefore, in these cases FDA has determined that products consisting of DBM and these components are not eligible to be regulated solely under section 361 of the Public Health Service Act. Instead, such products are regulated by the Center for Devices and Radiological Health under the medical device provisions of the Federal Food, Drug, and Cosmetic Act (Act).
Sponsors wishing to discuss regulation of a DBM product combined with a device component should contact the Division of Surgical, Orthopedic and Restorative Devices, Office of Device Evaluation, CDRH by telephone at (301) 796-5650.
1Federal Register of January 19, 2001 (66 FR 5447).
221 CFR 1271.10(a)
3The preamble to the final rule states that some “drugs or devices that have as their principal purpose sterilizing, preserving, or storage may also have a therapeutic effect or may be claimed to have such an effect. The addition of such drugs or devices would not fall within the exception for sterilizing, preserving, or storage agents.” (66 FR 5447, 5459.)