Former FDA Compliance Officer gives clear guidance on safety, effectiveness and regulatory compliance
PENSACOLA, Fla., Oct. 8, 2024 - Two critical legal opinions have been issued that offer healthcare providers definitive clarity on the regulatory standing of Regenative Lab's Wharton's jelly products. These documents provide essential guidance on the safe and effective use of Wharton's jelly, while underscoring their compliance with the Federal Trade Commission and the U.S. Food and Drug Administration regulations under Section 361 of the Public Health Service Act.
These legal opinions help cut through disinformation in the regenerative medicine market and give healthcare providers the confidence they need to use Regenative Lab's Wharton jelly products in a manner that ensures patient safety and regulatory compliance.
"While our priority is delivering innovative products, we're also deeply engaged in providing the clarity and regulatory assurance that physicians require so they can focus on what truly matters — delivering the best possible care to their patients," said Tyler Barrett, CEO of Regenative Labs. "Our Wharton's jelly products are designed with patient safety at the forefront, and these legal opinions affirm their standing as compliant, effective options for various regenerative applications."
Key Highlights
Safety and Effectiveness: Regenative Labs' Wharton's jelly products, including CryoText™ and SecreText™, are classified as 361 HCT/Ps, meaning they meet all regulatory criteria for minimal manipulation and homologous use. The products, for homologous use only, are for cushioning and structural support and have been shown to maintain their integrity after processing. This makes them effective for a variety of medical applications, including the repair of muscle and cartilage tears and other tissue injuries.
Regulatory Compliance: The legal opinions confirm that Regenative Labs' products meet all regulatory criteria under section 361 of the Public Health Service Act. This allows healthcare providers to use these products with assurance in their regulatory standing provided they are used within the confines of their intended homologous use. Physicians are also reminded to follow proper marketing guidelines to avoid the promotion of off-label uses.
Enhanced Availability for Patients: The clarity provided by these opinions ensures that healthcare providers can confidently offer Regenative Labs' Wharton's jelly products to patients knowing that they are safe, compliant and readily available. This means more patients will have access to innovative regenerative applications designed to enhance tissue repair, reduce recovery time and improve overall outcomes.
As the FDA increases its scrutiny of the regenerative medicine market, healthcare providers must be vigilant in selecting products that meet regulatory standards. Regenative Labs continues to set the industry standard by providing both innovative products and the legal guidance necessary to ensure their safe use in clinical practice.
"There is a safe and effective path forward," said Barrett. "These legal opinions give providers the assurance they need to offer our Wharton's jelly products, built on the foundation of scientific rigor and patient safety. We want what physicians want for their patients — the best safe and effective options available."
Request your copy of the product and provider legal opinions
Wharton's jelly explained
About Regenative Labs
Regenative Labs is a leading developer and manufacturer of regenerative medical products designed to improve patient outcomes through cutting-edge research and development. The company specializes in Wharton's Jelly allografts and other regenerative tissue products that provide structural support and promote healing. All Regenative Labs' products are manufactured under strict compliance with FDA guidelines, ensuring both safety and effectiveness.
For more information, visit www.regenativelabs.com.
Media Contact : Regenative Labs public relations | PR@regenativelabs.com | 800-891-3452
