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The 65 II A Medical Equipment & Supplies Schedule solicitation has been updated! The R9 Update Summary identifies relevant formatting changes, and includes a comprehensive listing of the updated clauses and provisions. Check out the 65 II A Schedule page for a list of documents that comprise the R9 solicitation package. Some important things to keep in mind when completing the new solicitation:
Under the previous 65 II A Schedule solicitations clause AS1904, Regulatory Requirement Provisions (August 2000) stated:
If the product(s) offered in this solicitation is are) considered medical devices by the U.S. Food and Drug Administration, offerors and/or subcontractors shall be in compliance with the Federal Food Drug and Cosmetic (FD&C) Act, as amended, and regulations promulgated there under. The general controls of the FD&C Act that medical devices are subject to are contained in the final procedural regulations in Title 21 Code of Federal Regulations (C.F.R) Part 800–1200. These controls are the baseline requirements that apply to all medical devices necessary for marketing, proper labeling and monitoring its performance once the device is on the market.
The non–italicized words above were not technically accurate — the general controls of the FD&C Act that medical devices are subject to are actually contained in Parts 800–1299 of Title 21 of the United States Code of Federal Regulations. The R9 refresh includes the updated C.F.R reference in the Regulatory Requirement Provisions of the solicitation document. The controls discussed in 21 C.F.R 1200–1299 are the base requirements that apply to the marketing, proper labeling, and monitoring performance of medical devices once on the market. Of particular importance are:
Genetically–derived products falling under these categories (i.e. allograft, xenograft items used in transplantation surgical procedures) are classified as medical devices by the Food & Drug Administration and may be considered for award/product addition under Schedule 65 II A.