Quality Control & Compliance

The owner of a Chicago COVID-19 testing lab plead guilty to wire fraud for billing the government for COVID-19 tests that were not performed. Also, test developer Talis Biomedical agreed to pay $32.5m to settle a shareholder suit.

There is to be more rigorous testing from now on for high-risk IVDs. Measures are also in place to prevent device shortages during the transition to new rules.

The regulatory, industrial and methodological changes applied to the medtech sector since the introduction of the US Food and Drug Administration’s design control guidance in 1997 are many and varied. Dr. Stuart Grant of Archetype MedTech looks at the challenges these changes present to both innovators and regulators and how the industry needs to adapt.

The ISRCTN clinical trials registry has launched an improved dashboard to provide metrics that reveal how many studies are complying with key transparency requirements. Badges are in place for individual studies meeting the transparency criteria.

Those working in the medtech sector returned from their traditional August break to a growing sense that the EU is more collectively aligned about the need to improve the medtech regulations and soon.

During an online seminar hosted by the Alliance for a Stronger FDA, Commissioner Robert Califf discussed key issues facing the agency, including supply chains, device shortages, and the risk of another pandemic.

The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.

So far, calls for much needed changes to the medtech regulatory system have focused on the Medical Device Regulation. Don’t neglect the IVD Regulation, industry says.

There is considerable focus at present on how far notified bodies can go in helping position their clients to have as smooth a conformity assessment passage as possible. It is a fine balancing act for all involved, but a new document gives useful insights.

The commission's recently reelected president also wants the new commission to evaluate the need for potential changes to the medtech regulations.

With the final deadlines for legacy products that need to comply with the IVD Regulation on the horizon next year, help is at hand to transfer responsibility for surveillance from one notified body to another. But who will need it and why?

This week, two device testing labs in China landed FDA warning letters; refunds for 1Health.io clients; FDA AR/VR product list expands. 

Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?

After a hiatus of nearly a year, the EU can celebrate another designation under the IVD Regulation.

In a letter to US lawmakers, the Association for Diagnostics and Laboratory Medicine says the FDA’s final rule regulating lab-developed tests will stifle innovation and that Congress needs to step in and stop it.

Centralization and rationalization of the EU’s medtech rules are critical, particularly for conformity assessment and clinical evidence. Hear the views of Tom Melvin and Erik Vollebregt first-hand in a new in-depth interview on regulatory problems and opportunities.