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Dive Brief: Responding to a mandate in the FDA Reauthorization Act of 2017 (FDARA), the agency Thursday released draft guidance delineating how the agency...
Appropriate Use of Consensus Standards: FDA Issues Draft and Final Guidance

USA – Appropriate Use of Consensus Standards: FDA Issues Draft and Final Guidance

To further promote international harmonization of device regulations, the US Food and Drug Administration (FDA) finalized guidance to aid manufacturers in appropriate use of...
Apple Sets the Stage for FDA Regulation on Two Types of AFib Mobile Medical Apps

USA – Apple Sets the Stage for FDA Regulation on Two Types of AFib...

The US Food and Drug Administration (FDA) granted two de novo classification requests on Tuesday on applications to be used with the Apple Watch...
Device Firms to Prep for Electronic Submission Shift Under FDA Proposed Rule

USA – Device Firms to Prep for Electronic Submission Shift Under FDA Proposed Rule

The US Food and Drug Administration (FDA) issued a proposed rule Wednesday that marks the official first step in shifting away from the current...
FDA Looks to Make FOIA Process Easier

USA – FDA Looks to Make FOIA Process Easier

The US Food and Drug Administration (FDA) on Wednesday proposed a new rulemaking that would ease the process by which the public can use...
FDA Revises 1989 Guidance on Drug Master Files

USA – FDA to bolster cybersecurity of medical devices

After a series of computer security problems in medical devices, the Food and Drug Administration (FDA) is taking steps to make sure companies do...
Risk Management Plans - Notice of clarification to drug manufacturers and sponsorsl Advisory Meetings to Medical Device Manufacturers

Canada – Health Canada to Offer Pre-clinical Advisory Meetings to Medical Device Manufacturers

EMERGO SUMMARY OF KEY POINTS: Health Canada’s Pre-Clinical Meeting program to provide feedback and recommendations to medical device manufacturers before they undertake clinical investigations. ...
Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

USA – US FDA Rolls Out Pilot for Simplified 510(k) Submissions

US FDA has launched a pilot program for streamlined 510(k) reviews using its eSubmitter software. Eligible premarket notification applicants are not required to...
Health Canada to Amend List of Recognized Standards for Medical Devices

Canada – Health Canada to Amend List of Recognized Standards for Medical Devices

Health Canada is seeking input on proposed changes to the current list of recognized standards for medical devices, including the removal of 20 standards...
Modernizing the Medtech Supply Chain

Study – Modernizing the Medtech Supply Chain

Medical devices move from manufacturer to healthcare practitioner through a complex supply chain that is in serious need of total, end-to-end modernization to improve...

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