DEEP DIVE: Wound Care Without the Wait? Decoding the FDA's 361 Exemption

Join me are we dive into a discussion on decoding the FDA's 361 Exemption - and what is mean for wound care providers. 

The FDA's 361 exemption rule, under the Public Health Service Act, offers a streamlined regulatory pathway for certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), including some wound care products derived from human tissues. To qualify for this exemption, HCT/Ps must meet specific criteria, including being minimally manipulated, intended for homologous use (performing the same basic function in the recipient as in the donor), not combined with other articles (with limited exceptions), and either lacking systemic effects or meeting specific use case exceptions. This exemption means these products are not subject to the rigorous premarket review required for drugs, devices, or biological products regulated under Section 351 of the PHS Act and the FDCA, which necessitates demonstrating safety and efficacy before marketing.

For manufacturers, the 361 exemption can lead to quicker market access and reduced regulatory burdens, but it also imposes limitations on marketing claims, which must be confined to the tissue's basic function as a cover or barrier in wound care. Consumers may benefit from faster availability of certain tissue-based treatments, but they also face concerns about the lack of premarket efficacy data. The FDA maintains oversight through registration, listing, and post-market surveillance, with increasing scrutiny and enforcement in recent years. Understanding the evolving regulatory landscape and the criteria for the 361 exemption is crucial for both manufacturers and healthcare providers in the wound care industry.