Briefs

Shanghai FDA Expands Medical Device Pilot Program

Shanghai FDA is expanding a pilot program for accelerating medical device registrations.

The pilot program was previously available to the Free Trade Zone in Shanghai’s Pudong district. Medtronic participated in the pilot program along with four other companies that saw their devices enter the priority registration channel.

More than 20 companies are actively participating in the pilot that is being extended to all of Shanghai.

Japan Highlights Regulatory Risks Of Medical Applications for AI

An expert group created by Japan’s Pharmaceuticals and Medical Devices Agency highlighted some concerns about the use of artificial intelligence in medical applications in a new paper published in the journal Advanced Biomedical Engineering.

AI-based systems using diagnostic images have “already surpassed the performance of human radiologists,” and machine learning has “enormous potential” in many applications, the PMDA Science Board’s AI subcommittee reported. But the subcommittee also cited concerns about the human-computer relationship and how this might impact medical care applications.

A core concern is that AI systems are capable of changing their performance through learning and this raises regulatory issues for the performance criteria.

The authors asked whether new registrations would be required if an AI system advanced itself and the challenges this would pose for manufacturers. A performance change may not always be positive, as it “may be worsened by improper learning,” they said.

Another major risk for devicemakers is the unpredictability of the AI output “due to the black box nature of the machine learning algorithms.”

The quality, efficacy and safety considerations for AI medical systems for their intended uses are just as important as for conventional medical devices, but “introducing AI-based technology may pose additional hazards not seen in the conventional medical devices and systems,” they said.

South Korea Releases Device Cybersecurity Risk Management Guidelines

South Korea published new guidelines on cybersecurity risk management for medical devices.

The Medical Security Guide mirrors the approach taken by the FDA and references the UL 2900 medical device cyber security standard along with other standards such as ISO/IEC 27002 and NIST 800-53.

It aims to establish a safe, smart medical service environment for medical information security officers and medical device manufacturers.

The guide covers medical devices, gateways, networks and medical information systems and proposes classification and component-specific requirements to address security threats.

Medtech Europe Cites REFIT Program as EU Governance Model

The Industry4Europe coalition, which represents 122 industry groups including Medtech Europe, released a joint policy paper calling for “informed dialogue” between the industry, decision-makers at EU, national, regional and local levels, as well as the civil society. The coalition cited the European Commission’s Regulatory Fitness and Performance (REFIT) program aimed at keeping EU law simple and removing unnecessary burdens as a particularly effective model.

The coalition proposes to adapt the REFIT program for industry to ensure that the competitiveness of the European industry is taken into account in all EU proposals to develop “an innovative and smart regulative framework with a long-term perspective.”

The REFIT program includes a government group, with one seat per EU member state, and a stakeholder group made up of representatives of business, social partners and civil groups.