A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Organizations that audit device establishments must ensure that their findings document conformity, nonconformity or potential nonconformity with established best practices based on objective evidence, according to a draft standard released by the International Medical Device Regulators Forum. The GMP Letter