Compliance
European Commission acts on call from industry for more guidance from notified bodies around innovation.
Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.
The US FDA has released its annual list of planned guidance documents for the upcoming fiscal year. While many topics on the list are familiar, a new “Under Construction” list shows rising priorities.
The European Parliament intends to send an official message to the European Commission to try and push for an early revision of the Medical Device Regulation.
The European Commission’s proposed timeframe for revising the MDR and IVDR is far too long, Parliament believes, and is resulting in increasingly outdated products in healthcare establishments around European threatening patient care.
Having 50 notified bodies under the Medical Device Regulation is a landmark achievement for the EU after a long and slow, journey to reach this point.
Just as manufacturers need to implement corrective and preventive action plans, so this is an essential part of how a notified body functions; new guidance explains how.
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 US Food and Drug Administration released three warning letters last month, two of which went to Chinese device testing labs accused of improper treatment of laboratory animals.
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.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
The US FDA has published final guidance to provide clarification for industry and agency staff on federal regulations of diagnostic X-ray equipment.
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.
Guidance documents issued 30 September explain how makers of air powered dental handpieces and air motors, dental cements, dental ceramics, and dental impression materials can bring their products to market by demonstrating compliance with established criteria, without a direct comparison to a predicate device.
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.
Patient centricity, diversity, innovation and transparency are key topics in the World Health Organization’s new guidance that recommends best practices for clinical trials and complements existing international guidance in this area.
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.