FDA lists proposed guidance publications for 2019

For Kapstone Medical

The FDA issued its list of proposed guidance publications for 2019 on Oct. 5 as part of its agreement to speed approvals of medical devices in exchange for additional funding from industry.

The Agency actually posted three lists: the “A list” includes guidance documents it intends to publish in the next 12 months; the “B list” includes documents the agency intends to publish as resources permit; a third list includes past documents that are due for retrospective review. (published site)

The release explains that years of experience have shown that the Center for Devices and Radiological Health (CDRH), which produces the guidance documents, rarely is able to complete the entire annual agenda of guidance documents due to diversions of staff to other activities including review of premarket and post market issues.

Thus it is hoped that by putting out an A and B list the agency will be able to prioritize feedback and comment on guidance topics and will use industry feedback as a factor in allocating resources to specific guidance topics. To that end, the Agency is soliciting comments on the lists themselves.

Specifically, the FDA is wants to hear from industry regarding the relative priority of guidance documents, as well as draft language on the proposed A-list and B-list topics, or suggestions for new or different guidance documents. To view the proposed lists, visit the CDRH Fiscal Year 2019 (FY 2019) Proposed Guidance Development webpage.

In addition, the FDA will be updating its medical device Guidance Documents website in a timely manner to reflect the Agency’s review of previously published guidance documents including withdrawal of documents that no longer reflect Agency interpretation of, or policy on, a regulatory issue.

To submit electronic comments, use the comment form at the Regulation.gov webpage. Comments will be placed in the docket and, except for those submitted as "Confidential Submissions.", will be publicly viewable at on the webpage or at the Dockets Management Staff office.

If you are facing issues with medical device regulatory processes Kapstone Medical has the experience and expertise to assist you through all phases of the device development and commercialization. For more information contact us today at (704) 843-7852 – or by email at info@kapstonemedical.com.