The applications for 3D printing in the healthcare field are great, and the technology makes it possible to create and administer patient-specific solutions as well. However, all of these advances, from pharmaceuticals to medical devices, must be scrutinized and regulated to make sure that they are completely safe, and effective, before they’re used on people around the world. In the US, the FDA takes care of implementing regulations before medical devices can be marketed; in Australia, it’s the Therapeutic Goods Administration (TGA).

Last November, regulatory changes were proposed to the TGA for 3D printed medical devices. The regulatory authority received 24 comments on the proposed changes, the majority of which came from industry; others came from care providers, device firms such as Stryker and Johnson & Johnson, and trade associations AdvaMed and the Medical Technology Association of Australia (MTAA).

“The TGA thanks respondents who provided submissions in response to the public consultation paper Proposed regulatory changes related to personalised and 3D printed medical devices,” the TGA wrote.

“The paper proposed regulatory changes to address the increasing trend for personalised medical devices. While the regulatory changes were not limited to 3D printed medical devices, 3D printing was one of the main themes, as this technology enables personalisation of medical devices in a fast and potentially up-scalable manner. The responses to the five proposals show broad stakeholder support for the TGA’s efforts and a strong awareness of the need for regulatory response and update.”

But instead of moving forward, the TGA, after receiving requests for clarifications from stakeholders, is delaying the implementation of these changes.

Last week, the TGA said in a notice, “The TGA plans to further explore other areas that were identified as requiring additional clarity prior to implementing regulatory change.”

3D Systems and K2M 3D printed medical device.

According to the regulatory authority, many of the comments by stakeholders were opposing the TGA’s proposed limitation on how many custom-made, 3D printed medical devices a manufacture can supply each year.

“Any number chosen as a limit is necessarily arbitrary, and may result in patients not being able to access needed technology,” said Jamie Wolszon, AdvaMed Associate Vice President of Technology and Regulatory Affairs.

Additional comments from stakeholders ranged from including anatomical models in the proposed framework to wanting more clarity from the TGA on the differences between how patient-specific and custom-made medical devices are defined for regulations.

The TGA said, “The need for clarification was especially evident regarding the boundary between the proposed ‘custom-made’ and the proposed ‘patient-specific’ definitions.”

Cook Medical also disagreed with the proposed limitation on the number of devices manufacturers supply annually, stating that the “proviso that ‘there is no commercially available alternative medical device’ will effectively provide a limitation on supply of custom made devices.” Additionally, the company argued that putting a “very small arbitrary cap” on this could limit access for the patients who need these 3D printed, custom-made devices. But, the company also said that this number in the US is limited to no more than five per firm each year.

Additional stakeholder submissions centered around areas of 3D printing that are newer to regulatory authorities, like how to define production environments and manufacturers. Regarding proposal 3 (“changes to the definition of manufacturer”), the TGA explained:

“Only slightly more than half of the submissions commented explicitly on proposal 3. Nevertheless, those submissions were very conflicting. About half of the submissions that took proposal 3 into consideration agreed with the TGA’s proposal. The other half raised issues like the need for further clarification, especially concerning the proposed medical device production system. Also, the exemptions for health care practitioners and hospitals were not fully supported. Another issue raised was the potential for added cost and administrative burden. Stakeholders indicated their uncertainty about what exactly should be considered a medical device production system and appealed to the TGA to clarify and potentially give examples.”

Comparisons were also drawn between regulations implemented over the last few years in the EU and the US, which are among the ten members of the International Medical Device Regulators Forum (IMDRF).

The consultation on defining personalized, 3D printed medical devices opened in March in Shanghai, at the 13th IMDRF meeting. This is not all bad news, however – most stakeholders were supportive of reclassifying the anatomical models and software that will be used to record diagnostic imaging, and proposals with positive feedback included ones that proposed changing the custom-made device conformity assessment procedure, in addition to granting the TGA permission to inspect the manufacturing sites of custom-made, 3D printed medical devices, and regulating scaffolds that had human materials “under the device framework for alignment with other jurisdictions.”

However, due to the recent concerns raised by stakeholders, the TGA has said that it “recognises the need for further stakeholder engagement on this subject.”

According to Regulatory Focus, “The notice indicates the regulatory body intends to use lessons learned from its ongoing process as chair of the IMDRF working group charged with achieving harmonized definitions for personalized medical devices and vice versa in terms of using the global efforts to inform the regulatory changes specific to Australia.”

The TGA’s conclusion notes that clarity is necessary to continue moving forwad with regulatory efforts in this area, as the notice sums up:

“Consistent throughout the submissions was a recognition of the need for the TGA to take action to improve the current arrangements for custom-made medical device regulation, which are too broad. In general, the submissions indicated that there is still need for more clarity. It was evident in the submissions that the current regulatory requirements are in many cases not fully understood. Greater explanation is also needed regarding the TGA’s proposals for change. This is mirrored in the comments regarding the proposed definitions and the plural demand for explanatory examples. The need for clarification was especially evident regarding the boundary between the proposed ‘custom-made’ and the proposed ‘patient-specific’ definitions. There were also several submissions indicating uncertainty, and requesting further explanation of what exactly would be seen as a medical device production system.”

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