DITTA Urges FDA to Fix MDSAP Inconsistencies

The Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association is calling on the FDA and the Medical Device Single Audit Program consortium to review the program’s inconsistencies and revise companion documents so devicemakers and auditing organizations are clear on expectations.

DITTA said its members continue to experience long wait times to schedule MDSAP audits and there is a need for more guidance to deal with inconsistencies among auditing organizations.

The association sent a letter to the FDA to enlist the agency’s help in improving the program ahead of next month’s International Medical Device Regulators Forum meeting in Beijing.