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Understanding regulatory compliance is essential when working with regenerative medicine products. Hawk Medical provides guidance and support to help your practice maintain compliance with FDA regulations.
This information is provided for educational purposes only and does not constitute legal or regulatory advice. Healthcare providers should consult with legal and compliance professionals regarding their specific regulatory obligations.
Human cells, tissues, and cellular and tissue-based products (HCT/Ps) are regulated by the FDA under 21 CFR Part 1271.
Our tissue products are regulated under FDA 21 CFR Part 1271, which governs human cells, tissues, and cellular and tissue-based products (HCT/Ps).
All our HCT/P products come from manufacturers who are properly registered with the FDA and comply with applicable regulations.
Tissue donors undergo rigorous screening and testing to ensure donor eligibility as required by FDA regulations.
We provide complete documentation for all products including lot numbers, expiration dates, and handling instructions.
Our tissue products meet the criteria for regulation solely under Section 361 of the Public Health Service Act. To qualify as a 361 HCT/P, a product must meet all of the following criteria:
Products meeting these criteria are not subject to premarket approval or 510(k) clearance requirements, but manufacturers must still register with the FDA and comply with donor eligibility, processing, and labeling requirements.
As part of our partnership, we help practices develop Standard Operating Procedures (SOPs) for handling regenerative medicine products. Proper SOPs are essential for maintaining compliance and ensuring patient safety.
Our team can help you understand regulatory requirements and develop appropriate procedures for your practice.
Our team is ready to help you navigate regulatory requirements and ensure your practice maintains compliance.