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Compliance In Focus
Posted by John Lehmann on Fri, Mar 27, 2015

AdvaMed Provides FDA with its Own Priority List

AdvaMed, the medical device trade group has never been shy about sharing its opinion with theAdvaMed Provides FDA with its Own Priority List FDA.  According to a recent article in Medical Device and Diagnostic Industry (MD+DI), AdvaMed has voiced its opinions on what priorities the medtech industry believes the FDA should prioritize.

In January, the Center for Device and Radiological Health (CDRH) released its Fiscal Year 2015 Proposed Guidance Development.  It provided a prioritized list of topics which CDRH may issue draft and final guidance documents on.  The topics are broken into two lists – an A-list and B-list.  According to the CDRH, they intend to publish guidance on the A-list topics, while B-lists topics will be published as resources permit.

On March 10th, AdvaMed provided a response.  It gave the CDRH its  list on topics they believe are the most important.  It is not a surprise that their list did not sync up with the list provided by the CDRH.  The top four topics outlined as highest priorities for AdvaMed members is as follows:

  • Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
  • Framework for Regulatory Oversight of Laboratory Developed Tests
  • FDA Notification and Medical Device Reporting for Laboratory Developed Tests
  • Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility)

One area of difference is with the oversight of laboratory developed tests (LDTs).  Many have been unhappy and claim that the balance of pre- and postmarket data collection will slow innovation if the FDA is given oversight of LDTs. 

This prioritization is not surprising, as oversight of laboratory developed tests (LDTs) has been hotly debated for a few years and there are efforts underway to address the balance of pre- and postmarket data collection.

Beyond the topics listed by CDRH, AdvaMed says it would like to see other topics added to the high priority list:

  • PMA modifications (update)
  • Manufacturing site changes (update)
  • Update to "Internet/Social Media Platforms with Character Space Limitations; Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices."
  • Device-Specific Guidance Documents: 1) Co-development guidance and 2) Guidance on non-molecular types of multi-marker panels

What are your thoughts on AdvaMed’s list of priorities when compared to the FDAs?  Share your thoughts below.

Photo Credit: R/DV/RS

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