FDA is considering whether to reassign primary jurisdiction of certain tissue-based products, such as interactive wound dressings, to the Center for Biologics Evaluation & Research.

Currently, premarket review and regulation of these combination products is primarily handled by the Center for Devices & Radiological Health.

The matter will be discussed during a June 24 FDA public hearing in Rockville, Maryland on the regulatory future of combination products consisting of living cells combined with a device matrix. While the hearing will focus on wound-healing products, the agency notes that information gathered at the meeting could be applied to other combination products that contain live cells.

The agency is planning to solicit general information about combination products containing live cellular components. In addition, FDA will ask participants to make recommendations on regulatory requirements for approval and on how to draft and implement a consistent policy for product assignment.

Interactive wound products "have increasingly been the subject of questions regarding both jurisdiction and pre- and postmarket requirements," the meeting notice states. "Depending upon the information presented at the hearing, the agency could conclude that the primary mode of action of some or all of these products is that of the cell component, and that the product(s) should be reassigned to CBER."

Jurisdictional issues surrounding the majority of combination tissue-engineered products historically have been a gray area, FDA staffers admit. Staffers note that the upcoming hearing is "another step in the agency's continuing efforts to clarify and refine its regulatory approach to products that are comprised in whole or in part of living cells or tissues."

Device industry stakeholders have been pushing FDA to make their regulatory policies surrounding combination products more consistent.

The matter also has garnered attention on Capitol Hill. The "Preparing for the 21st Century Medical Technology Act," (HR 3580), for example, calls for creation of an Office of Combination Products that would be responsible for updating the agreements, clarifying policy and tracking measures such as review times for combination products. Introduced by Reps. Jim Greenwood (R-Penn.) and Anna Eshoo (D-Calif.), portions of the bill may be included in a larger bioterrorism package later this month.

Since HR 3580 was introduced in December 2001, FDA has appointed a combination product program director and has been involved in several meetings on the topic with interested stakeholders (¹ Also see "Separate FDA Combo Products Website Proposed By Device Reps To Kramer" - Medtech Insight, 13 May, 2002., p. 16).

In October 2001, FDA officials indicated that tissue-engineered products were the focus of early discussions on revising FDA intercenter agreements, last updated in 1991. FDA maintained it would hold public meetings prior to making any jurisdictional changes (² Also see "Tissue Product Jurisdiction One Focus Of Intercenter Agreement Talks" - Medtech Insight, 29 October, 2001., p. 16).

In June 2000, a draft guidance, "Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment," was jointly issued by the agency's drugs, devices, and biologics centers. A final guidance has not been issued.

Under the 1991 intercenter agreements, CDRH has primary jurisdiction over cultured skin products. Among firms that have had PMAs approved for such products are Advanced Tissue Sciences, Integra LifeSciences, Organogenesis and Ortec.

Advanced Tissue Sciences, which was among companies that met with Combination Products Program Director Mark Kramer earlier this month, will attend the June hearing, according to the company.

Another hearing addressing general policy issues for combination products might follow the upcoming hearing on products containing live cellular products, FDA staffers suggest.

The June meeting will not address single-entity products, combination products containing bone, ligament and vascular products used for structural purposes and drug-device combination products, according to the notice. In addition, combination products with a gene therapy component also have been left off the agenda.

Comments for the June 24 meeting should be submitted to FDA prior to June 14. FDA will continue to receive comments for the administrative record through Aug. 23.

Wound-Healing Product Jurisdiction To Be Challenged At June FDA Hearing

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