UPDATE – FDA Guidelines for Orthopedic Regenerative Medicine:

As a leader in Orthopedic Regenerative Medicine, The Albano Clinic is dedicated to the development of safe and effective regenerative therapies. We recognized the need to work within the FDA’s framework years ago and currently have an Investigational Device Exemption (IDE) (#27960) in place with this governing agency.

In June 2021 the FDA began enforcement of its new Regulatory Pathway which will impact all Regenerative Medicine Providers, hospitals, and facilities. As you, the patient, research clinics, and physicians, it is essential that you ensure they have an IND, IDE, or BLA in place with the FDA. Those that have not been following the current FDA’s guidelines will be sanctioned by this entity for not ensuring safe and effective Regenerative Medicine treatment options.  Those who are not following the current FDA’s regulations are doing so illegally and not ensuring safe, effective, and compliant Regenerative Medicine treatments. Please select this link for more information.