GMP. As used herein, “GMP” means current good manufacturing practices, including without limitation the FDA’s Quality System Regulations pursuant to Title 21 of the United States Code of Federal Regulations, Part 820, as applicable to the manufacture of a Class 2 medical instrument to gain 510(k) approval by the FDA.
Appears in 9 contracts
Samples: Supply and Manufacturing Agreement, Supply and Manufacturing Agreement (Quanterix Corp), Supply and Manufacturing Agreement (Quanterix Corp)
GMP. As used herein, “GMP” means current good manufacturing practices, including without limitation the FDA’s Quality System Regulations pursuant to Title 21 of the United States Code of Federal Regulations, Part 820, as applicable to the manufacture of a Class 2 [2] medical instrument to gain 510(k) approval by the FDA.
Appears in 3 contracts
Samples: Development Services and Equity Participation Agreement, Development Services and Equity Participation Agreement (Quanterix Corp), Development Services and Equity Participation Agreement (Quanterix Corp)