Regulatory Documentation
Organogenesis Inc. is committed to the highest standards of ethical conduct and regulatory compliance and is committed to conducting its business affairs and interactions with Health Care Practitioners in a manner that is compliant with all applicable laws, regulations, and industry guidelines.
The regulatory documents provided below are those that are commonly requested for administrative purposes. These documents are updated on a routine basis. For additional documents or information, please contact the Organogenesis Medical Information Center.
Email: 
Telephone: 1-888-432-5232, Option 2
Links to FDA Documents
- FDA Approval Letter, reflective of approved clinical indications
- FDA Form 3356 for 150 Dan Road, Establishment Registration & Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products(HCT/Ps)
- FDA Form 3356 for 85 Dan Road, Establishment Registration & Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
- FDA Device Establishment Registration
Links to Tissue Bank Licenses
- American Association of Tissue Banks accreditation certificate
- California state tissue bank license
- Illinois state tissue bank registration
- Maryland state tissue bank permit
- New York state tissue bank license
Link to Apligraf Storage Information