Food and Drug Administration’s Position on Commonly Injected Biologic Materials in Orthopaedic Surgery: Letter to the Editor

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.

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.”)

Fang WH Vangsness CT . Food and Drug Administration’s position on commonly injected biologic materials in orthopaedic surgery. Am J Sports Med. 2021;49(12):3414-3421. doi:10.1177/0363546521990900

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

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

FDA. Same Surgical Procedure Exception Under 21 C.F.R. 1271.15(b): Questions and Answers Regarding the Scope of the Exception, November 2017, at p. 3. https://www.fda.gov/media/89920/download

FDA. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications, July 2014, at p. 16. https://www.fda.gov/media/82395/download.

FDA. United States Code of Federal Regulations, 21 CFR § 607.65(b) - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=607.65

FDA. United States Code of Federal Regulations, 21 C.F.R. 862.2050 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=862.2050

FDA. United States Code of Federal Regulations, 21 C.F.R. §1271.3(d) - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=1271.3

FDA Regulation: 21 C.F.R.1271.3(d)(2) (excluding “whole blood or blood components and blood derivative products” from definition of HCT/P.)

Manchikanti L Centeno CJ Atluri S , et al. Bone marrow concentrate (BMC) therapy in musculoskeletal disorders: evidence-based policy position statement of American Society of Interventional Pain Physicians (ASIPP). Pain Physician. 2020;23(2):E85-E131.

Mazzocca AD McCarthy MBR Chowaniec DM Cote MP Arciero RA Drissi H. Rapid isolation of human stem cells (connective tissue progenitor cells) from the proximal humerus during arthroscopic rotator cuff surgery. Am J Sports Med. 2010;38:1438-1447.

New Drug, Antibiotic, and Biologic Drug Product Regulations; Final Rule, 52 Fed. Reg. 8798, 8803 (March 19, 1987).

U.S. v. Caronia, 703 F.3d 149, 155 (2^nd Cir. 2012); citing U.S. Food and Drug Administration, Guidance for Industry, Responding to Unsolicited Requests for Off–Label Information About Prescription Drugs and Medical Devices (2011), at 2-3.