The report also found that medical device companies are taking “huge gambles” in the area of risk management.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
The total value of deals for 2019 exceeds $30 billion.
The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.
This two-part virtual workshop will guide participants through the process of how to write effective documents.
If you’re looking to market your medical device, there are many tasks to complete.
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.