IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices

USA – IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways

The International Medical Device Regulators Forum (IMDRF) has begun wading into harmonizing the premarket review process, regulatory pathways for personalized devices and cybersecurity, following...
Examining US FDA criteria for medical device cybersecurity and risk management

USA – FDA Reduces Regulatory Burden for Female Condoms

The US Food and Drug Administration (FDA) on Wednesday issued a final order lowering the regulatory burden for device makers looking to market single-use...
Biosimilar use may increase with scrutiny of high drug prices

USA – US Regulators Update Policies for Medical Device Voluntary Consensus Standards

EMERGO SUMMARY OF KEY POINTS: US FDA draft guidance explains agency’s process for recognizing voluntary consensus standards used for medical device declarations of conformity. ...
FDA Reveals Vision for the Transition to ISO 13485

USA – FDA Reveals Vision for the Transition to ISO 13485

An apology was offered to device firms during a session at the MedTech Conference in Philadelphia on Tuesday by the US Food and Drug...
Patent Considerations for Connected Medical Devices

USA – Intuitive Surgical Could Help Usher in a New Era for Medtech

More than a decade ago Amazon recognized that it needed mass-cloud computing power, but didn't believe there was a third party service available to...
Meta-Analyses of Randomized Trials: FDA Offers Draft Guidance

USA – Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance

Failing to submit trial data to ClinicalTrials.gov may start to cost drug and device makers, the US Food and Drug Administration (FDA) said Thursday...
FDA Finalizes Guidance on Delayed Graft Function in Kidney TransplantationRay Imaging Devices With International Standards

USA – Device Makers Call for Changes to FDA’s Biliary Stent Guidance

Medical device makers Boston Scientific and Cook are calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on 510(k) submissions...
MYnd Analytics stock rallies after FDA gives breakthrough status for company device

USA – MYnd Analytics stock rallies after FDA gives breakthrough status for company device

Shares of MYnd Analytics inc (NASDAQ:MYND) popped on Monday after the US Food and Drug Administration (FDA) granted breakthrough device designation for the company's...
Examining US FDA criteria for medical device cybersecurity and risk management

USA – FDA Follows Up on Alcon’s CyPass Withdrawal With Eye Damage Risk Alert

The US Food and Drug Administration (FDA) issued a safety communication on Friday to alert of a potential risk of eye damage in patients...
Special 510(k)s: CDRH’s Proposed Program Expansion Draws Mixed Reactions

USA – FDA rolls out plan to reduce third party 510(k) re-reviews

Dive Brief: Responding to a mandate in the FDA Reauthorization Act of 2017 (FDARA), the agency Thursday released draft guidance delineating how the agency...

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