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.
Five years after first talking about a unique device identifier that medical device makers would need to put on most medical devices and packaging, the FDA is nearing the end of the comment period for its proposed rule. MedCity News