Early July Australia’s TGA issued letters to multiple device companies calling in technical data on custom surgical implants. The requests were issued to sponsors who hold ARTG registrations for surgical procedure kits which include custom device components.
This is a step in what’s likely to be a tightening of Australian regulation for 3D printed implants.
Manufacturers and sponsors will need to make careful and considered individual responses to these requests. But it’s also important to understand that the outcome of this broader exercise will inform TGA’s approach to regulatory reform of custom devices.
Show me the data
Of course the primary need here is that the documentation submitted is adequate to sustain TGA scrutiny of the individual device and demonstrate compliance with safety and performance regulations – after all that’s what manufacturer, quite literally, signed up to in issuing a Declaration of Conformity.
It’s been a common misconception that the absence of a requirement to register a custom device means an absence of regulation. That’s not so. The only exemption is from the premarket review and inclusion on the register. Custom devices still need to meet the full regulatory requirements including having adequate safety data and clinical evidence.
Manufacturers without adequate data to support their devices may found out the hard way that they risk cancellation of regulatory approvals by TGA.
The recent updates to the European Medical Device Regulation brought mass-produced custom devices under full Conformity Assessment controls for the first time (“Mass-produced custom devices” may seem a contradiction in terms but it simply refers to the large scale commercial production of custom devices in industrial settings – think dental laboratories making bespoke dentures and bridges on prescription.) The US FDA takes a strict approach – requiring any custom device for which more than five are produced in a year to be subject to FDA 510(k) clearance or Premarket Approval (PMA) according to classification. Similarly Canada requires mass-produced custom devices to have a Canadian medical device license.
Which leaves TGA as the odd one out in allowing custom devices to be supplied without any premarket review.
TGA reform plans
The approach to custom device regulation in Australia was developed with low risk devices in mind. Indeed the TGA website still lists things like dental appliances, glass eyes, orthotics, external prostheses and prescription lenses as examples of custom devices. However the advent of advanced manufacturing technologies such as 3D printing to manufacture bespoke surgical implants has changed all that.
So TGA is actively considering regulatory reform.
TGA made a first step towards strengthening custom device regulation with introduction of a notification scheme in April 2016, which requires manufacturers to inform TGA of the commencement of supply of custom devices. This TGA presentation given to the Australian Dental Industry Association [PDF Download] provides a thorough overview of the current regulatory requirements.
But more is to come. This presentation on regulatory reform given at AusMedtech [PDF Download] in May by TGA Head John Skerritt makes specific reference to new technologies including 3D printing and flags a TGA workshop which is planned for August.
Calling in the data now will give TGA a better picture of how robust is the compliance for currently marketed devices – and the quality of those data and adequacy of manufacturer responses will certainly influence the agency’s future direction on custom devices.
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