In a recent comment to the US Food and Drug Administration (FDA), a global medical technology organization comprised of several industry trade associations offered potential solutions to reported issues facing the Medical Device Single Audit Program (MDSAP).
The Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association’s (DITTA) letter cites issues identified in a survey the group conducted earlier this year on the experience member companies participating in MDSAP have had with auditing organizations (AOs).
Respondents’ feedback was shared in the letter to provide specific examples of the concerns DITTA and its members still have, Carolyn Hull, manager of global regulatory standards at the the Medical Imaging & Technology Alliance (MITA), told Focus
. DITTA represents MITA and the national association of Canada’s medical technology companies (MEDEC), among others.
MDSAP has continued to gain momentum, despite the challenges. Officials from FDA’s Center for Devices and Radiological Health (CDRH) recently reported
the number of MDSAP participants increased to a total of 1,749 as of Q1 2018, compared with just 788 in 2017.
Health Canada, however, faces unique challenges
with its MDSAP design and has implemented a number of changes to facilitate the transition for small- to medium-sized device companies ahead of the agency’s 1 January 2019 compliance deadline. In contrast with other countries, MDSAP participation will be a requirement to market devices in Canada.
The issues facing companies in the program reportedly relate to “long wait times to schedule audits and receive audit results or certificates, despite MDSAP program guidelines that require adherence to specific timelines,” Patrick Hope, chair of DITTA and executive director at MITA, wrote in the 18 July letter in which Health Canada was copied.
“Companies continue to note variances between audits at different manufacturing plants that make it difficult for manufacturers to ensure they receive certification under MDSAP,” Hope added. Other issues relate to inconsistent interpretation of findings gathered during MDSAP audits at different manufacturing sites and the associated “organization, costs, and planning.”
The letter calls on the MDSAP consortium to provide clarifications as to why audits are conducted against the requirements in all countries in the program and involve reviews of premarket applications that have already been approved.
MDSAP is a cornerstone of the International Medical Devices Regulators Forum, which now includes regulatory agencies from 10 countries. But the MDSAP consortium involves a total of five countries: US, Canada, Brazil, Japan and Australia. Thus, why audits against the EU’s Medical Devices Directive are being conducted remains unclear as well, the letter adds.
Some of the potential solutions DITTA offers to FDA for tackling issues such as inconsistent scoring methodologies include providing updated training materials and guidance documents
“We believe training updates would improve consistency of results, reduce variance in the interpretation of results, and help to speed time to certification,” Hull said. “Improved training would also help reduce uncertainty and lower costs for manufacturers.”
Hull further argued for updates to training and guidance to help the agency work to ensure that MDSAP firms and AOs are aware of the timeline requirements. “The FDA should monitor audit results and continue to seek feedback on the program from MDSAP participants,” she said.