COMMERCIAL ITEM DESCRIPTION A-A-51540
Certificate of biocompatibility. A certificate of compliance, stipulating that offered items meet the biocompatibility test, shall be acceptable, provided that the contractor has supplied acceptable items to the Government within the past three years and that there have been no changes to material formulation and the method of processing since actual testing was performed. The processing since actual testing was performed. The certificate shall include the date the testing was performed, the test method and results, the name and title of the person evaluating the results, the current contract number and National Stock Number (NSN), a statement certifying that material processing and formulation have not changed since the time that biocompatibility was performed and the signature and title of the person making the certification.
Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
Regulatory requirements.
Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.
Recovered materials. The offeror/contractor is encouraged to use recovered materials in accordance with Public Law 94-580 to the maximum extent practical.
Preservation, packaging, packing, labeling and marking. Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc. involving shipment from the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carrier’s rules and regulations. Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order.
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