Dive Brief:

• Australia's Therapeutic Goods Administration is planning to overhaul its regulation of software as a medical device (SaMD).

• TGA wants to reclassify SaMDs to better reflect the threat devices pose to patients, resulting in some products jumping from the lowest to the highest risk category.

• The reclassification would significantly increase the regulatory burdens on SaMD developers but TGA thinks the change is necessary to minimize public health and safety risks.

Dive Insight:

Medical device software existed when TGA drew up its framework for the industry in 2002, but was dramatically different in nature than it is today, leading to a framework that only considered how a device could cause harm by physically interacting with a human.

The idea that software could providing an incorrect diagnosis — and that people could source the software direct from companies outside TGA's jurisdiction — was not on the agenda. As a result, TGA treats all SaMDs as low risk.

In 2019, SaMDs are toward the top of regulatory agendas around the world. Having spent last year commissioning research into SaMDs and creating guidance, TGA has now set out how it plans to overhaul its regulation of the sector.

The top priority is to reclassify SaMDs to better reflect the potential to cause harm. While all SaMDs are treated as low risk, Class I devices today, many products would be categorized as Class IIa, IIb and III interventions under the new rules.

TGA plans to treat SaMDs used in life-threatening screening, diagnosis and dosing decisions as Class III devices. Similar devices used in more routine situations will either be in Class IIa or IIb, depending on the risk the decision poses to the patient. A digital therapeutic will fall into Class IIb if it could result in patient harm, or Class IIa or below if the risk it poses is minimal.

The proposal is in line with the incoming medical device rules in Europe, but features detail TGA felt was lacking from its counterpart's position, and hews closely to principles set out by the International Medical Devices Regulators Forum (IMDRF).

FDA is involved in IMDRF but its position is a little different, in part because of the 21st Century Cures Act. The legislation excluded software that supports or provides recommendations about the prevention, diagnosis or treatment of disease from the medical device definition, rendering it outside of FDA's jurisdiction. TGA, in contrast, plans to put software that aids diagnosis in Class IIa. Another, broader difference is that FDA has generally sought ways to prevent overregulation. 

TGA's position on the shortcomings of its own regulation led it to focus its proposals on strengthening regulatory oversight. That underpins the planned reclassification and a proposal to exclude SaMDs from provisions that allow personal importation.  

Australia's importation rules allow people to source therapeutic goods from overseas, provided they are only used by the individual or an immediate family member. When applied to SaMD, the rules allow people to download software from foreign companies. The companies do not need to register their products with TGA and are not accountable to the agency for the safety of their software.

By excluding SaMD from personal importation rules, TGA would require software providers to have a sponsor in Australia and register their products with the agency. How TGA would enforce this rule is unclear, with the draft document released this week stating only that “mechanisms for adherence to these requirements may include exploring agreements with large scale SaMD providers (app stores) that have an Australian presence.”

TGA is seeking feedback on the proposed changes are supported by the industry until March 31.