Guidance
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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in schools; the former CEO of device company Stimwave was convicted on two counts of fraud; and the FDA issued a draft guidance document on the thermal affects of medical devices.
Cybersecurity Guidance Update Lays Out ‘Cyber Device’ Rules
Draft guidance from the US Food and Drug Administration details what the agency wants to see to demonstrate cybersecurity in connected devices during premarket submissions.
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.
News We’re Watching: First OTC Blood Glucose Monitor, Recalls For Ventec and Medtronic, Guidance Docs Under White House Review
This week, the US FDA announced that it had cleared Dexcom’s Stelo Glucose Biosensor System, making it the first OTC device of its type available in the US. Additionally, the Office of Management and Budget took up guidance documents on cybersecurity and enforcement on diagnostics during emergencies, and recalls were announced by Medtronic, Ventec and Cardinal.
Global Medtech Guidance Tracker: February 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
FDA Guidance Doc Would Waive Registration Fees For Bankrupt Small Businesses
The document waives the annual registration fee for companies with gross sales below $1m that are currently going through bankruptcy.
FDA Details Preferred Approach To Collecting Diversity Data
In a recent guidance document, the FDA explains how trial sponsors should collect and present data on the race and ethnicity of trial participants.
What Devices Are Essential During A National Emergency? FDA Panel Makes A List
Members of the US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee met on 6 February to discuss what medical devices are critical to public health during a national emergency and help the FDA create a list of those devices.
Global Medtech Guidance Tracker: January 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
The FDA Unleashes The Beast: A New Tiger Team For Sterilization
The second meeting in a series of town halls by the FDA announced the creation of a Tiger Team dedicated to medical device sterilization innovation.
FDA Issues Draft Guidance On Premarket Submissions For Coated Orthopedic Devices
The US Food and Drug Administration has published draft guidance offering recommendations for premarket submissions for orthopedic devices that contain metallic or calcium phosphate coatings.
Comments On Off-Label Communications Guidance Point Out Possible First Amendment Violations
Stakeholders argue the draft limits crucial decision-making information and infringes on manufacturers’ free speech.
New Sterilization Methods Receive Guidelines For 510(k) Submissions
New guidance from the FDA clarifies premarket submission details for devices sterilized with novel methods.
US FDA Considers Making More Guidance Final Without Public Comment
Increased use of the ‘immediate implementation’ provision in the agency’s Good Guidance Practices could help reduce stakeholder uncertainty.
Global Medtech Guidance Tracker: December 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
FDA Issues Draft Guidance On Real-World Evidence For Medical Devices
The US FDA is clarifying how it evaluates real-world data when making regulatory decisions on medical devices.
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