1. Alexander v. Smith & Nephew, 98 F. Supp. 2d 1299 (N.D. Ok. 2000) holding that FDA regulations do not impose a standard of care on practitioners.
2. Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349-350 (2001); citing 21 U.S.C. § 396 (“Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”)
3. Food and Drug Administration’s Position on Commonly Injected Biologic Materials in Orthopaedic Surgery
4. FDA. Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-based Products (HCT/Ps), July 2021. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/questions-and-answers-regarding-end-compliance-and-enforcement-policy-certain-human-cells-tissues-or
5. FDA. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, July 2020. https://www.fda.gov/media/109176/download