CDRH releases Four Final 510(k) Guidances

USA – CDRH releases Four Final 510(k) Guidances

Thursday the CDRH released the following 510(k) guidances : Special 510(k) Program Format for Traditional and Abbreviated 510(k) Abbreviated 510(k) Refuse to Accept Policy 510(k)
Scratching the surface: Medical device companies’ evolving efforts to tackle cybersecurity

USA – Scratching the surface: Medical device companies’ evolving efforts to tackle cybersecurity

Anyone paying even the slightest attention to today’s media has likely seen numerous reports on cybersecurity risks associated with medical devices. Some reports are...
FDA issues final guidance on de novo approvals

USA – FDA issues final guidance on de novo approvals

The FDA has released final guidance to clarify exactly what medtech companies need to include in their requests for the agency to review their...
De Novo Requests: FDA Finalizes Three Guidances

USA – De Novo Requests: FDA Finalizes Three Guidances

The US Food and Drug Administration (FDA) on Friday finalized three guidance documents related to de novo classification requests for medical devices. Devices using the...
Weight-Loss Devices: FDA Seeks Feedback on Benefit-Risk Considerations

USA – Weight-Loss Devices: FDA Seeks Feedback on Benefit-Risk Considerations

Ahead of a planned draft guidance on assessing the benefits and risks of new weight-loss devices, the US Food and Drug Administration (FDA) on...
Humanitarian Use Device (HUD) Designations

USA – Humanitarian Use Device (HUD) Designations

This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD) designation requests to the U.S. Food...
New Report Compares FDA Quality System Requirements With ISO 13485:2016

USA – New Report Compares FDA Quality System Requirements With ISO 13485:2016

The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for...
Mexican regulators to require online submission of medical device import permit applications

Mexico – Mexican regulators to require online submission of medical device import permit applications

The Mexican government will begin requiring electronic submission of all import permit applications starting September 24, 2019. According to new rules now published (link in Spanish) in...
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (Draft Guidance)

USA – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR)...

This guidance document applies to all implanted medical devices, external medical devices that are fastened to or carried by a patient (e.g., external insulin pump),...
FDA approvals of new cancer drugs have doubled in this decade

USA – US FDA finalizes post-market safety reporting guidance for combination products

Final guidance issued by the US Food and Drug Administration explains how combination product manufacturers should comply with post-market safety reporting requirements originally established...

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