Compliance with FDA Guidelines at The Denq Clinic
At The Denq Clinic, our commitment to following FDA guidelines has been a cornerstone since our inception. As the field of regenerative medicine continues to advance, we remain dedicated to ensuring the safety and effectiveness of our treatments while adhering to all regulatory requirements.
Our procedures involve the use of human cells, tissues, and cellular/tissue-based products (HCT/Ps) intended for medical purposes. We carefully adhere to FDA classifications, whether dealing with structural tissues like cartilage and bone or nonstructural tissues such as stem cells and immune cells.
Minimal Manipulation and Homologous Use
We take care to maintain the natural characteristics of these tissues in line with FDA definitions of minimal manipulation. Our therapies are designed for homologous use, meaning they are used to perform the same basic function in the recipient as they did in the donor.
Same Surgical Procedure Exception
When utilizing a patient’s own tissues (autologous use), our procedures ensure that the HCT/Ps are removed and re-implanted within the same surgical session, with minimal processing to maintain their original form.
Adhering to Regulatory Standards
The Denq Clinic focuses on treatments that fall under section 361 of the Public Health Service (PHS) Act and meet the criteria set forth in 21 CFR 1271.10(a). This means our therapies are minimally manipulated, intended for homologous use, and do not require premarket FDA approval. We follow the guidelines of current Good Tissue Practice (cGTP) and ensure all our cellular therapies are processed according to FDA standards.
Our Commitment to Safety and Compliance
At The Denq Clinic, we utilize only minimally manipulated autologous products, such as adipose tissue and bone marrow aspirate, specifically for orthopedic treatments. We do not offer intravenous or intranasal use of these products. All procedures are performed under homologous use and within the same surgical session, ensuring full compliance with FDA regulations.
Any claims or statements to the contrary do not reflect the practices of The Denq Clinic and may be subject to legal action.
