Center for Devices and Radiological Health (CDRH)
Aric Kaiser, an expert biomedical engineer with experience in tissue mechanics and mechanical testing, has regulatory and scientific interests in the design and evaluation of products intended to treat orthopedic disorders. Of particular interest are tissue-engineered medical products (combination products) and devices intended to serve as functional replacements for the diseased or damaged tissue, e.g., products intended to repair/regrow damaged cartilage with functional tissue rather than implantation of synthetic materials as in total joint replacements. Recent work has focused on bone void fillers containing calcium salts, collagen and/or recombinant human proteins or synthetic peptides.
Proposed Regulatory Research Project for the FDA Commissioner's Fellow:
The Division of Orthopaedic Devices has seen an increase in the number of applications for bone void fillers used in a variety of orthopedic applications over the last several years. The complexity of these fillers, particularly those incorporating recombinant human proteins/synthetic peptides or modified manufacturing methods, would be enhanced by a review and production of a “lessons learned” and/or minimum non-clinical evaluation document based on recent applications. An example would be identification of the evaluations necessary to differentiate devices that have identical chemistry, e.g., calcium phosphate, but different final characteristics, e.g., surface topography or surface charge. In addition to these types of general documents, a guidance document describing the requirements for submissions investigating fracture healing would also be very useful to agency staff and industry.
The fellow would also participate in reviews of pre-IDEs, IDEs, 510(k)s and PMAs on these products and interact with staff from other review groups for products with dental and orthopedic uses, from OSB concerning post-market issues, as well as staff from CDER, CBER and CVM concerning pre- and post-market issues associated with these products.
FDA Fellows participating in this program will learn the basic science, regulatory science and review processes associated with the regulation of bone void fillers (with and without recombinant human proteins or synthetic peptides.) The project will include an evaluation of past applications and clearances/approvals to look for commonly resolved issues, tests and clinical study design in order to provide background for new guidance documents or other internal/external communications within FDA and with industry.
The applicant should have a Ph.D. or M.S. (with at least 3 years of research experience) in an appropriate engineering (biomedical, chemical, materials or mechanical) or scientific discipline with experience in bone biology/chemistry, tissue engineering, regenerative medicine and non-clinical testing of biological materials.
Selected Recent Publications/Presentations:
Kaiser, AD, McFarland, RD, Dawisha, SM and Leibenhaut, S: Points to Consider in the Design of Nonclinical and Clinical Evaluations of Products Intended to Repair or Replace Articular Cartilage, FDA Science Forum, April 27-28, 2005.
Kaiser, AD: Science-based Testing for Combination Devices, Proceedings from the Workshop on Science-Based Assessment – Accelerating Product development of Combination Medical Devices, Bonnie A. Scarborough, ed., The National Academies Press, 2004.
Jean, RP, Hill, GA, Kaiser, AD, Buch, BD: Hot Topics in Regulatory Science: FDA's Impact on Orthopaedic Surgeons and Their Patients, 75th Ann AAOS, 2009.
Kaiser, AD (2011) Biologics | Combination Products Are Not Solely Biological Products, Drugs, or Devices: A Regulatory Perspective. In: Moo-Young M, (ed.) Comprehensive Biotechnology, Second Edition, vol. 3, pp. 399-409. Elsevier.
Guidance document - Preparation of IDEs and INDs for Products Intended to Repair or Replace Articular Cartilage, December, 2011.
“Overview of the History of FDA Regulation of Devices Made from Bone”, FDA Open Public Meeting on: Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair, August 2, 2000.
“Medical Device Regulations—From Research to Marketing: Regulation of Bone Graft Substitutes.” Biomedical Engineering Society Annual Meeting, September 28, 2005.
"Combination Products That Include Biologics - Novel Combinations Require Novel Assessments", WCBP 2008, 12th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products, January 30, 2008.
“Orthopaedic product regulatory process today and tomorrow: The inside perspective”, Orthopaedic Research Society Annual Meeting, February 7, 2012.