Streamlining approval processes for human cells, tissues and cellular and tissue-based products

(a) In general Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall— (1) conduct a comprehensive review of the approval process applied to human cellular and tissue allografts and autografts that are not subject to regulation only under section 361 of the Public Health Service Act, including those processed into liquid, gel, or powder forms; (2) identify opportunities to streamline application requirements, review timelines, and evidentiary standards for such products while maintaining appropriate safety and efficacy oversight; (3) consider the development of a tiered review framework based on risk assessment factors including degree of manipulation, processing methods, mode or administration, and clinical safety profile; (4) evaluate the need for pre-market clinical evaluation and the appropriateness of leveraging existing clinical data, real-world evidence, and registry data to reduce duplicative clinical trial requirements where scientifically justified; and (5) assess mechanisms to harmonize requirements between products currently regulated only under section 361 of the Public Health Service Act that may transition to section 351 regulation. (b) Stakeholder consultation In conducting the review under paragraph (1), the Secretary shall consult with— (1) manufacturers of human tissue allografts; (2) tissue banks and procurement organizations; (3) clinicians specializing in wound care, surgical reconstruction, and regenerative medicine; (4) patient advocacy organizations; (5) health insurance payors; and (6) relevant scientific and medical professional societies. (c) Considerations The review shall specifically consider— (1) appropriate modifications to Chemistry, Manufacturing, and Controls (CMC) requirements reflecting the biological nature and donor-dependent variability of human tissue; (2) potential use of expedited review pathways, including priority review designations; (3) opportunities for modular or staged application submissions; (4) appropriate clinical endpoint criteria and study designs for different types of allografts and autografts; (5) post-market surveillance requirements as an alternative to pre-market evidence requirements; and (6) international regulatory approaches to similar products. (d) Guidance Not later than 24 months after the date of enactment of this Act, the Secretary shall issue draft guidance implementing any streamlining measures identified under subsection (b), and shall finalize such guidance not later than 12 months after the close of the public comment period. (e) Report to congress Not later than 30 months after the date of enactment of this Act, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the review conducted under subsection (b), including— (1) findings and recommendations for regulatory streamlining; (2) any administrative actions taken or proposed; (3) recommendations for additional legislative action, if any; and (4) estimated impacts on patient access and public health. (f) Preservation of safety standards Nothing in this section shall be construed to reduce or eliminate safety or efficacy standards applicable to human tissue allografts or autografts subject to licensure under section 351 of the Public Health Service Act.