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.
The FDA is developing new methods and laboratory expertise to aid reviewers in identifying potential vulnerabilities and assessing risk mitigation measures for medical software. The agency also is considering reverse engineering certain types of malware to identify specific protective practices devicemakers should be employing to prevent cybersecurity breaches. The GMP Letter