FDA publishes List of Planned Guidances on Medical Devices for 2016

At the end of 2015, the Center for Devices and Radiological Health (CDRH) published a list containing the guidelines planned for fiscal year 2016 (1st October 2015 - 30 September 2016) as well as older guidelines which might need an update.

The CDRH is FDA's department in charge of regulating medical devices. CDRH's guidelines, policies, etc. are the basis for FDA's inspections of medical device manufacturers too. The actual list is just as long as a paper page.

Interestingly, the CDRH has divided its list in priority A and B. The documents in the A-list should be published at first. Provided that sufficient resources are available after the A priorities have been processed, those documents are also intended to be published in 2016. Beneath this, the FDA has included - relatively pragmatically - the finalisation of current draft documents.

The list of guidelines which are subject to a retrospective review in 2016 comprises 4 pages and is significantly longer. They include guidelines from 1976, 1986, 1996 and 2006. Next year, the guidelines from 1977, 1987, 1997 and 2007 will be reviewed, etc. This 10-year review cycle should continue until  2025. Interested persons are explicitly invited to comment on those lists.  

It is interesting to notice that the document deals with the question whether the CDRH expects from the list planned to be also fully implemented. The answer is "no" even if the word "no" doesn't appear as such in the text. There may be setbacks due for example to the creation of new guidelines with regard to emerging issues - or due to new priorities of the employees which couldn't be foreseen (e.g. concerning authorisation or vigilance activities).

That is the reason why interested groups are expressly invited to communicate to the FDA their prioritisation with regard to essential guidelines in the diverse areas in order to enable the FDA to make a customer-oriented use of its resources when planning the creation of new guidelines or revising old guidelines.

Conclusion: With the publication of the list of guidelines planned for medical devices in fiscal year 2016, the FDA has submitted a declaration of intent. Guidelines directly addressed to the quality assurance system or "GMP" are not explicitly including in the A-/B-list.

All details can be found in the complete list: "CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance.

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