What Guidance Documents Will CDRH Issue in 2017?
FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 2017.
Tag Archives: regulatory
CDRH Releases FY 2017 Regulatory Priorities
Highlights include leveraging big data, streamlining clinical trial design, reducing healthcare-associated infections and toughening up on cybersecurity.
Top Three Disconnects in Product Development
The unpredictability of the process can make it difficult to stay on track throughout every phase.
Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing
Why regulatory and quality due-diligence is often overlooked.
Fail to Respond to Form 483 Observations and Win a Warning Letter
A monumental screw up, complete with bad quality, regulatory and statutory practices.
FDA Files Consent Decree Against Medtronic and CEO Omar Ishrak
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
Medtronic Beats Edwards with Valve-in-Valve Replacement Use for TAVR
FDA has granted a first-of-its-kind expanded approval for Medtronic’s CoreValve System for valve-in-valve replacement.
FDA has granted a first-of-its-kind expanded approval for Medtronic’s CoreValve System for valve-in-valve replacement.
Medical Devices in Canada: How to Enter the Market
When launching a new product, manufacturers may want to consider Canada first.
When launching a new product, manufacturers may want to consider Canada first.
The QA/ RA Cheat Sheet
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
