When outsourcing these key functions, asking the right questions will help minimize the risk.
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.
FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 2017.
Highlights include leveraging big data, streamlining clinical trial design, reducing healthcare-associated infections and toughening up on cybersecurity.
The unpredictability of the process can make it difficult to stay on track throughout every phase.
Why regulatory and quality due-diligence is often overlooked.
A monumental screw up, complete with bad quality, regulatory and statutory practices.
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
FDA has granted a first-of-its-kind expanded approval for Medtronic’s CoreValve System for valve-in-valve replacement.
When launching a new product, manufacturers may want to consider Canada first.