Australia’s Therapeutic Goods Administration is urging devicemakers to meet with the agency before submitting conformity assessment applications.
The agency said it highly recommends pre-submission meetings for novel devices and devices used for urogynecological procedures. The meetings are most beneficial for new or emerging technologies, novel medical devices, combination products and medicines with a companion diagnostic.
Pre-submission meetings can provide a common understanding of what supporting documentation is needed to evaluate an application as well as resolve any issues before the application is submitted, the TGA noted, in the update to its 2013 guidance.
The updated guidance introduces numerous changes covering applications for conformity assessments for medical devices.
The agency clarified that it can offer advice on concerns companies have relating to existing studies of a proposed data package, but it does not address issues that require evaluation of data and it does not give advice on developing a data package or on the number of studies required to support an application.
Devicemakers wishing to request a pre-submission meeting should submit a meeting request form and say whether they want a teleconference, videoconference or a meeting in person. Companies should tell the agency who will be attending, including consultants and their titles. Requests for meetings should allow at least four weeks advance notice but not more than two months, the agency said.
Companies should submit a briefing package two weeks before the meeting to allow the agency time to analyze data, including:
No new material should be presented during the meeting that is not included in the full briefing package, the guidance says. If important new information becomes available within the preceding two-week period, companies should send an updated presentation to the TGA at least 48 hours before the scheduled meeting.
After the meeting, the agency will provide a summary of the agreed outcomes and any action items. Devicemakers should include a copy of the final meeting record in the application dossiers for TGA conformity assessment certificate submissions.