FDA Launches Pilot Program To Qualify Medical Device Development Tools-thegraysheet: FDA has launched a pilot program to help it develop the final guidance on qualifying medical device development tools (MDDT). The Aug. 15 document, titled “Pilot Program for Qualification of Medical Device Development Tools,” builds on FDA’s Nov. 2013 draft guidance for plans to improve the device approval process by creating a system for FDA to formally qualify development tools for any company to use. Experience with the MDDT pilot program will help inform FDA’s final guidance on the MDDT qualification processes, FDA explains.
