Policy & Regulation
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Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development
Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.
EU Institutions Reach Provisional Agreement On Proposed Health Data Regulation Amendments
Key changes have been agreed to the original European Commission text which would allow patients to opt out or restrict sharing of their information.
News We're Watching: LDT Survey Finds Concern, Abbott Recall, New Q-Sub Guidance
This week, the US Congress advanced legislation that would support better cardiac emergency preparedness in schools; the former CEO of device company Stimwave was convicted on two counts of fraud; and the FDA issued a draft guidance document on the thermal affects of medical devices.
MedTech Europe Calls For Swift Answers In Areas Where AI Act Threatens MedTech
With the EU AI Act close to being finally adopted, industry is now calling for guidance and clarification to prevent the new legal text complicating the regulation of medical devices and diagnostics and putting obstacles in the way of patient access to innovation.
EU Institutions Reach Provisional Agreement On Proposed Health Data Regulation Amendments
Key changes have been agreed to the original European Commission text which would allow patients to opt out or restrict sharing of their information.
MedTech Europe Calls For Swift Answers In Areas Where AI Act Threatens MedTech
With the EU AI Act close to being finally adopted, industry is now calling for guidance and clarification to prevent the new legal text complicating the regulation of medical devices and diagnostics and putting obstacles in the way of patient access to innovation.
40% Plus Growth In Notified Body Certificates Issued Under EU Medtech Regulations
After years of concern over notified body ability manage the volume of conformity assessment applications from medtech manufacturers, there is evidence that capacity has increased significantly, and this is showing results.
Day 2: IMDRF Guidance Documents In The Works
Discussions during the second day of the 25th session of the International Medical Device Regulators Forum focused on the establishment of working groups to iron out a plethora of issues for international harmonization.
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