The CDRH (Center for Devices and Radiological Health) recently released their annual proposed Guidance development document for the upcoming fiscal year. This provides an overview of the intended guidance documents FDA plans to fully publish, and those documents FDA hopes to publish.
Why is CDRH posting the latter of the two? During the negotiations of MDUFA (Medical Device User Fee Act), FDA agreed to meet a variety of quantitative and qualitative goals to help get safe and effective medical device to market more quickly. The User Fee Amendments also resulted in FDA agreeing to:
- Post annually a list of prioritized device guidance documents that FDA intends to publish within 12 months of the date this list is published each fiscal year
- Post annually a list of device guidance documents that FDA intends to publish as resources permit each fiscal year
- Update our website in a timely manner to reflect FDA’s review of previously published guidance documents, including the deletion of guidance documents that no longer represent the FDA’s interpretation of, or policy on, a regulatory issue, and notation of guidance documents that are under review by FDA
- Provide stakeholders an opportunity to provide feedback, including draft language for guidance documents
It looks like FDA has a lot on their list stemming from MDUFA and we’ll most likely be seeing a lot more updates from CDRH this coming year.
FDA has also established a docket for comments on any of all of the proposed 2013 guidance documents. As stated on their website, FDA also “invites interested persons to submit comments, draft language on the proposed topics, suggestions for new or different guidance documents, and/or relative priority of guidance documents.”
Tomorrow we’ll be posting the current list of guidance documents FDA has as a “top priority” to publish, as well as those guidances FDA intends to publish if time and resources allow.
What guidance documents do you hope to see on the list? Comment below and let us know!
Photo Credit: cathredfern