FDA’s 361 Exemption Rule

Navigating the 361 Exemption in Wound Care: A Key Regulatory Pathway

By: Dr. Jenneffer Pulapaka, DPM
DipABLM, CWSP®, DipABMSP, FACCWS, PCWC, retd. AACFAS
Medical Director
DeLand Foot and Leg Center
Podiatric Lifestyle Medicine and Wound Care Management
AAWC BOD

 For professionals in the dynamic field of wound care, understanding the regulatory landscape is crucial. Among the various pathways established by the Food and Drug Administration (FDA), the 361 exemption stands out as a significant route for certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). This article provides a concise overview of this exemption and its implications for wound care professionals.

The FDA, through Sections 351 and 361 of the Public Health Service Act (PHS Act), employs a risk-based approach to regulate HCT/Ps. Section 361 grants the FDA the authority to issue regulations aimed at preventing the introduction, transmission, or spread of communicable diseases. Importantly, it also outlines criteria under which specific HCT/Ps are exempt from premarket review. This is the essence of the 361 exemption.

What does this mean for wound care products? Certain tissue-derived products utilized in wound management can potentially qualify for this exemption. This offers manufacturers a potentially faster route to market with reduced regulatory hurdles compared to drugs, devices, or biologics requiring rigorous premarket approval to demonstrate safety and efficacy.

Key Advantages of the 361 Exemption (for Manufacturers):

• Faster Market Entry: The absence of mandatory premarket review can significantly shorten the time it takes for a product to become available to patients.
• Reduced Regulatory Burden: The requirements for demonstrating safety and efficacy are less stringent compared to other regulatory pathways.

Important Considerations and Limitations:

While the 361 exemption offers advantages, it’s crucial for professionals to be aware of its limitations, particularly concerning marketing claims. Products cleared under this exemption cannot make claims beyond homologous use (repair, reconstruction, replacement, or supplementation of the recipient’s cells or tissues with a human HCT/P with similar basic functions and characteristics in the recipient as in the donor) and must adhere to specific criteria outlined in 21 CFR Part 1271.

Implications for Clinicians and Patients:

For clinicians, the 361 exemption can mean quicker access to certain tissue-based wound care products. However, it also implies that these products have not undergone the same level of premarket scrutiny as products requiring formal FDA approval. This necessitates a thorough understanding of the available clinical data and careful consideration of the product’s suitability for individual patients.

Patients may benefit from the faster availability of these products. However, the lack of extensive premarket efficacy data underscores the importance of transparent communication with healthcare providers regarding the evidence supporting their use.

Recent Regulatory Focus:

The FDA has increasingly emphasized the importance of accurate product classification and strict adherence to the 21 CFR Part 1271 criteria for wound care product manufacturers utilizing the 361 exemption. This heightened scrutiny aims to ensure that products marketed under this exemption truly meet the established criteria and do not make unsubstantiated claims.

Staying Informed:

Navigating the regulatory landscape requires continuous learning. Wound care professionals should stay updated on FDA guidelines and any changes to the interpretation and enforcement of the 361 exemption. Consulting resources from the FDA and professional organizations is essential for making informed decisions regarding the use of tissue-based products in wound care.

In Conclusion:

The 361 exemption offers a unique regulatory pathway for certain HCT/Ps in wound care, providing potential benefits in terms of market access. However, it is accompanied by crucial limitations, particularly concerning marketing claims and the level of premarket review. A thorough understanding of this exemption, its criteria, and recent regulatory trends is paramount for wound care professionals to ensure optimal patient care and compliance.

For the full Article READ:  The FDA’s 361 Exemption Rule and Its Application to Wound Care​

Related Articles

Related