Former FDA Compliance Officer gives clear guidance on safety,
effectiveness and regulatory compliance
PENSACOLA, Fla., Oct. 8, 2024
/PRNewswire/ -- 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
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SOURCE Regenative Labs