AusBiotech’s response to ‘Draft Clinical Evidence Guidelines’ for medical devices, commended the TGA on its continuing efforts to work with industry to improve its service and provided supportive comment on the utility of the Guidelines document, the clinical and technical requirements and made suggestions for development of category-specific sections.
AusBiotech and its AusMedtech Regulatory Affairs Expert Panel reviewed the consultation document and are supportive of the TGA’s intended outcome to assist sponsors and manufacturers to move efficiently through the regulatory system and welcomed the creation of guidance documents for areas currently without adequate guidance.
AusBiotech said further definition and clarification of the identified areas would assist in streamlining clinical report preparation for sponsors and improve the quality of the reports submitted to the TGA for evaluation.
The submission said: “By reducing common errors and enhancing consistency of review and regulation the TGA will address their proposed outcome of assisting sponsors and manufacturers to move more efficiently through the regulatory system.”
While recognising the Draft does not represent an official position and has been provided to generate discussion and seek constructive feedback, the AusBiotech submission addressed:
- The utility of the Guidelines document, including scope, structure and expression, noting that periodic updates of the Guidelines will ensure their ongoing relevance to both the TGA and industry. AusBiotech said it understands that the TGA intends to implement such updates, via electronic publication, and supported this approach.
- The clinical and technical requirements, including defining the role of the author of clinical reports, and providing greater clarity for the definition of ‘substantial equivalence’ to improve consistency and understanding by industry and regulators.
- Suggested further category-specific sections to be developed.
The full submission can be found at the AusBiotech website.