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.
DITTA surveyed its members and found that many devicemakers have to wait several months to get audit date confirmations and certificates from auditing organizations.
The association also said there were wide discrepancies among audits at different manufacturing plants, making it difficult for manufacturers to ensure they receive MDSAP certification, due to different interpretations of findings that effect costs and planning.
For example, the association said some auditing organizations “believe that all activities that are conducted by resources outside of the four walls of a site should be treated as outsourced processes, even if conducted under the same quality management system. This was clarified in the ISO handbook but it is not widely known by AOs.”
There are also inconsistent audit time calculations and audit response criteria where multiple certification schemes are audited at the same time. For example, MDSAP nonconformance response timeframes and the evidence required do not align with ISO, DITTA said.
In addition, inconsistencies in the scoring methodologies among different AOs are causing confusion, with some manufacturers noting inconsistencies within individual AOs.
Manufacturers said that each AO “seems to have a different interpretation of what is considered a ‘repeat’ finding,” and the inconsistences are creating problems for devicemakers as repeats can impact on the failure or success or their audits.
Duplications Not Part of the Plan
Devicemakers also questioned why audits for the EU Medical Devices Directive are being conducted as part of MDSAP audits when the EU is not a participating MDSAP member.
AOs are also requesting to review premarket applications that have already been reviewed and approved by regulators and some AOs are auditing against the requirements of all five MDSAP countries even if the audited site is not required to be audited by a certain jurisdiction.
The association urged the FDA to work with the MDSAP consortium to draft additional documents to address the inconsistencies.