Open Public Meeting - Human Bone Allograft
August 2, 2000 - Slide Presentation
Overview of Relevant Comments to the Proposed Rules Dockets Concerning Regulation of Bone Products
Martha A. Wells
CBER, FDA
Review of Comments to Dockets of Proposed Regulations
- 5/14/98 Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products
- 9/30/99 Suitability Determination for Donors of Human Cellular and Tissue-Based Products
General Comments: Homologous Use and Minimal Manipulation
- Terms are vague - subject to broad interpretation
- Do not reflect clinical use of the products
- Questions on how the criteria will be applied
- Should be eliminated
- Agrees with the focus on promotion and labeling rather than the intent of the practitioner
- Requests more guidance on how the definition will be applied
Comments: Bone in General
- Support/Against regulation of allograft
- Against further/additional regulation
- Against interference with patient care, doctor-patient relationship, practice of medicine
- Support/Against regulating bone allograft as a medical device
- Mechanical shaping of bone is minimal manipulation
Concerns:Regulation of Bone
- Curtailment of supply
- Increased cost without increased safety
- Satisfaction with industry standards
- Manipulation of bone by shaping should not determine the level of regulation
- Long history of safe use
- FDA lacks authority to impose premarket approval oversight on allograft bone
Comments: Bone Dowels
- Support/Against regulatory evaluation of machined or formed allografts as devices
- Support/Against regulation of allograft for procedures requiring stabilization
- Premachined dowels are superior to those machined in the operating room
- Mechanical shaping is not more than minimal manipulation
- Against regulation based on the shape of bone
- Shaping of bone by manufacturer should be regulated the same as shaping by the surgeon
- Superior to similar metal devices
- Should undergo the same degree of regulation as required for metallic implants
Conclusion
- Can't satisfy everyone- conflicting views
- Majority of comments based on misinformation spread by interested parties - all bone as devices
- More information is needed on bone allografts and their use
- Clarification of the definitions is needed
- Possible need for guidance
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