Moreover, the FDA-required outcomes for approval must be stipulated in the clinical design protocol. These IDE studies must be prospective, controlled, blinded and statistically-powered prior to the onset. The IDE study requirements include strict oversight from the FDA from statistical and protocol design through clinical follow-up, data integrity and analysis. Once again, since most 510(k) cleared products have little to no peer-reviewed human clinical data, surgeons must extrapolate the likely benefits in their clinical use.ĭrug-device combination bone grafts are Class III and require an investigational device exemption (IDE) clinical trial followed by a premarket approval (PMA) application. This review is generally based on a single animal study and bench-top testing comparing the subject device with a predicate. Market clearance requires the filing and review of a 510(k) application and a subsequent FDA review. Section 510(k) describes a regulatory process for the clearance of products that have been demonstrated to the FDA’s satisfaction to be “substantially equivalent” in safety and effectiveness to another lawfully marketed device when used for the same purpose. Synthetic bone grafts and demineralized bone matrices (DBMs) fall under Class II under Section 510(k) of the Federal Food, Drug and Cosmetic Act. Since most HCT/P products have little to no peer-reviewed human clinical data, the surgeons must extrapolate the likely benefits in their clinical use. Therefore, there are no requirements for preclinical or clinical data. There is no premarket review by FDA for safety or effectiveness of such products. Once a manufacturer determines a product meets all of these requirements and follows the appropriate regulations, the manufacturer can place the product on the market by simply notifying the FDA of the intent to do so. Section 361 describes products that are minimally manipulated, are for homologous use only, do not have a systemic effect, and are not dependent on the metabolic activity of living cells for their primary function, in addition to other qualifications. Nonstructural allograft and cellular allograft products, which do not rely on the metabolic activity of living cells, are considered to be HCT/P products under the United States Code of Federal Regulations Title 21-part 1271 (HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS). A large reason for these challenges is that the regulatory pathways and required evidence leading to FDA approval for spinal bone graft substitutes vary widely. The preclinical and clinical evidence available for making a clinical use decision is also enormously varied and subject to misinterpretation. The claims about the function and value of these products are confusing, even to those with the time and expertise to evaluate them in-depth. The number and variety of bone grafting products available to choose from is extensive, totaling more than 400 at the current time. Most of the options available today fall short of these goals. The ideal bone graft substitute for spinal fusion would have the safety and effectiveness of autograft when used by itself, be supported by quality published clinical evidence, and be available at a reasonable cost. This chapter will discuss these products along with their supporting clinical data. The OP-1 Implant (rhBMP-7) was marketed for a period of time, but it has been removed from the market. the other technologies, which are autograft extenders. Both of these products have been shown to be effective autograft replacement options, vs. Currently, there are only two PMA-supported Class III drug-device bone graft substitutes with Level I data that demonstrate equivalence to autograft for safety and effectiveness in spine: Infuse® (rhBMP-2) and i-FACTOR (P-15 peptide). Drug-device combination bone grafts are Class III and require an investigational device exemption (IDE) clinical trial followed by a premarket approval (PMA) application with the FDA to review safety and effectiveness. Synthetic bone grafts and demineralized bone matrices (DBMs) fall under Class II and require a 510(k) for market clearance, generally on the basis of an animal study. Nonstructural allograft and cellular allograft products that do not rely on the metabolic activity of living cells are HCT/P products, which require no premarket review for safety and efficacy. This chapter is focused on the USFDA regulation and the related efficacy evidence of bone graft materials, especially Class III drug-device combination products for use in the spine.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |