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TORONTO @ Health Canada is very close to publishing a much-anticipated guidance on artificial intelligence/machine learning (AI/ML) medical devices and has incorporated pre-determined change control plans (PCCP) into the document, according to Marc Lamoureux, manager of the Digital Health Division at Health Canada.

TORONTO @ The UK Medicines and Healthcare products Regulatory Agency (MHRA) plans to publish a public consultation on a proposal to allow medical devices automatic access to the UK market if they are authorized in a comparable regulator country (CRC) by the end of the year. Depending on the outcome of the consultation, the international reliance (IR) policy could be introduced as legislation in the British Parliament next year.

TORONTO@With only about half of de novo submissions granted authorization, officials from the US Food and Drug Administration@s (FDA) Center for Devices and Radiological Health (CDRH) said that sponsors should take advantage of its pre-submission process and obtain data from investigational device exemption (IDE) trials to improve their products@ chances of getting to market.

TORONTO @ The former director of the US Food and Drug Administration@s (FDA) Center for Devices and Radiological Health (CDRH) said he hopes lawmakers pass legislation to allow the agency to develop a voluntary alternative pathway (VAP) and enable greater international reliance to better meet the needs of new technologies.

Michelle Tarver has been named@the new permanent director of the US Food and Drug Administration@s (FDA) Center for Devices and Radiological Health (CDRH), nearly three months after being named acting director after former CDRH had Jeff Shuren announced he would vacate the position. The trained ophthalmologist has been crucial in the agency@s ongoing efforts to ensure equity in medical product development and its efforts to focus on advancing healthcare solutions in the home.

TORONTO @ As medtech companies work to comply with the European Union@s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), stakeholders disagree on whether legislative action is needed to revise the regulations to prevent products from leaving the EU market.

TORONTO @ Medical product sponsors should consider clinical trial diversity plans as not only a regulatory requirement but also a marketing opportunity because they will give companies data that is more representative of their patients, according to Michelle Tarver, who was recently named director of the US Food and Drug Administration@s (FDA) Center for Devices and Radiological Health (CDRH).

Welcome to another installment of This Week at FDA, your weekly source for updates @ big and small @ on FDA, drug, and medical device regulation, and what we@re reading from around the web. This week, FDA named the new permanent director of its medical device center, House Republicans published a report criticizing the Biden administration@s promotion of COVID-19 vaccines, and a much-anticipated draft guidance on communicating scientific information about unapproved uses of drugs is a step closer to being finalized.

The European Parliament has adopted a resolution to update the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to avoid potential product shortages in the region, sketching out a timeline for when such changes will be proposed. The move comes as manufacturers have continued to voice concerns about the ability to meet deadlines to transition their products to the new regulations.

The European Commission@s Medical Device Coordination Group (MDCG) has issued guidance on how the medtech industry should handle ethylene oxide (EtO) under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The sterilizing gas is widely used by the medtech industry to clean products, largely due to its ability to penetrate small spaces.