definiens: ) ( collecti vely, ) . Each Medical Device, as that term is defined in 21 U.S.C. § 321(h ) of the F D&C Act, that is manufactured, tested, distributed and/ or marketed by the Seller, is being manufactured, t ested, distributed and/or marketed by the Seller in materi al compliance with applicable FDA Law and Regulatio n, including those relating to : good manufacturing pra ctices ; regulatory approvals or clearances to marke t Medical Devices in the United States ; investigational studi es ; labeling ; record keeping ; and filing of reports to FDA . The Seller has not received any notice or communication from the FDA alleging material noncompliance with any applicable FDA Law and Regulation . The Seller is aw are of no pending or completed FDA proceedings seek ing the recall, withdrawal, suspension or seizure of an y Medical Device against the Seller . To the Knowled ge of the Seller, the Seller is not the subject of any curren t enforcement proceedings by the FDA