Commenters Suggest Changes to TGA Clinical Evidence Guidelines

Draft clinical evidence guidelines for medical devices published by Australia’s Therapeutic Goods Administration (TGA) should deemphasize the use of literature reviews and equivalence determinations, and instead focus on clinical evidence specific to particular devices, commenters said.

Several comments also said the TGA should generally avoid interpreting its medical device regulations and guidelines — including the clinical evidence guidelines — to provide more stringent requirements than those in the European Union, which could make the Australian market less attractive to device manufacturers.

The TGA received 19 comments by the close of the comment period June 10.

Current Expectations

The draft guidelines outline current expectations for clinical evaluation reports and underlying evidence that must be supplied by manufacturers.

The document provides specific information on the clinical evidence requirements for total and partial joint prostheses; cardiovascular devices to promote patency or functional flow; electrical impulse generators; heart valve prostheses; supportive devices such as meshes, patches and tissue adhesives; and implantable medical devices in the magnetic resonance environment.

This evidence may be requested in support of applications for conformity assessment, inclusion in the Australian Register of Therapeutic Goods, and post-market monitoring.

The Bupa Group, which delivers a wide variety of medical services in Australia and New Zealand, criticized the draft guidelines for appearing “to accommodate the presentation of literature reviews and ‘equivalence’ as being appropriate clinical evidence for a device, even where there are modifications to the device that would necessarily differentiate it from prior iterations.”

The group said the draft guidelines may provide too much flexibility for some devices to rely on literature reviews. It recommended that clinical evidence regarding the actual device under review be the primary focus, unless there are clear and compelling reasons for a lower benchmark.

The Medical Technology Association of Australia (MTAA) had a number of specific suggestions, such as clarifying which supporting documents are required with clinical evidence. In addition, the MTAA said that:

• Randomized controlled clinical trials are in most cases unsuitable for medical devices;
• Clinical quality registries, where available, can provide a high level of ongoing safety monitoring during the post-market phase, and the TGA could use the data from such registries to ensure that adverse event reporting aligns with actual experience; and
• Manufacturers of implantable medical devices should be able to decide the best way to provide essential product information, including magnetic resonance imaging safety status.

Medtronic Australasia Pty Ltd said although the draft guidelines resemble EU guidance for clinical evaluation in many respects, the TGA’s interpretation of its medical device requirements “is often to the highest level possible.”

Medtronic said the provisions of the draft guidelines might be similarly interpreted when they are finalized, which will make it more difficult to bring some products to the Australian market, which is only 2 percent of the global market.

The draft guidelines can be read here: www.fdanews.com/11-09-16-TGAGuidance.pdf. — Jeff Kinney