Public consultation: Proposed application audit framework for medical devices

We invited feedback on a proposed risk-based application audit framework for medical devices, including In Vitro Diagnostic (IVD) medical devices. The framework described how we proposed to select medical device applications for audit and conduct those audits.

The key elements of the proposed application audit framework included:

• risk factors informing non-mandatory audit selection,
• criteria for mandatory audits,
• the evidence to be provided with applications to inform audit selection,
• limiting the number of substantial assessment rounds,
• mechanisms to improve visibility of application audit timeframes
• cost recovery measures for non-mandatory audits, and
• pathways for Class III devices with Medical Device Single Audit Program (MDSAP) certification and US FDA 510(k) approval.

We received twenty-six (26) submissions.

The overall level for the proposed new risk-based application audit framework was positive with broad support for:

• limiting mandatory audits to Class III, Class 4 IVD, Class 3 IVD, point-of-care and self-test IVD medical devices
• exempting medical devices with recognised comparable overseas regulator approvals from mandatory audit
• establishing a new mandatory audit pathway for Class III medical devices with MDSAP and US FDA 510 (k) approval
• repealing clause 5.3(1)(j)(viii) in the Regulations, relevant to IVD medical devices, because it is ambiguous and non-transparent in its operation.

Most respondents supported the proposal for the TGA to publish risk factors that influence non-mandatory audit selection, but they wanted more clarity about the rationale for the proposed risk factors and how each risk factor would be weighted and combined to influence the audit selection decision.

Most respondents expressed concerns about:

• requiring applicants to submit the Instructions for Use and the Clinical Evaluation Report for Class III devices with European Medical Device Regulation certification
• limiting audits to two substantial rounds of review.

Most respondents suggested improvements to the application audit process, including improved communication, transparency, and timeframes. Respondents said we should not delay improvements while we deliver the TGA digital transformation project.

The consultation responses supported the proposed changes to the criteria for mandatory audits and the proposed MDSAP and US FDA 510(k) pathway. The TGA is seeking Government approval to amend the legislation accordingly.

Next Steps

The TGA is also using the feedback from the consultation to:

• develop detailed guidance on the risk factors we will consider when selecting applications for audit. Once the guidance is published, we will review the risk factors periodically
• do further work to review the evidence we require to be provided with applications to inform audit selection. We will review the requirement for applicants to provide clinical evidence for all class III medical device applications with comparable overseas regulator approval
• improve the way we communicate with applicants about these audits
• improve assessment timeframes for these audits, including considering establishing target timeframes.