FDA Will Post CDRH's 2013 Proposed Guidance Documents for Early Review and Comment

November 26, 2012—In the Federal Register, the US Food and Drug Administration (FDA) announced that it will post online two lists of guidance documents that the Center for Devices and Radiological Health (CDRH) is intending to publish in fiscal year 2013. The FDA intends to update the list each year.

In addition, the FDA has established a docket where stakeholders may provide comments and/or propose draft language for those topics, suggest new or different guidance documents, and comment on the priority of topics for guidance. The FDA noted that it is not required to publish every guidance on either list if the resources needed would be to the detriment of meeting quantitative review timelines and statutory obligations. Also, the agency is not precluded from issuing guidance documents that are not on either list.

The lists of guidance documents that the CDRH is intending to publish in fiscal year 2013 can be accessed on the FDA's website. Also, electronic or written comments on the proposed guidance can be submitted at any time at www.regulations.gov or be mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

The FDA stated that it anticipates that feedback from stakeholders, including draft language for guidance documents, will allow the CDRH to better prioritize and more efficiently draft guidances that will be useful to industry and other stakeholders.

According to the FDA's notice, during negotiations on the Medical Device User Fee Amendments of 2012, the agency agreed—in return for additional funding from industry—to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly. These commitments include annually posting a list of prioritized medical device guidance documents that the agency intends to publish within 12 months of the date that the list is published each fiscal year (the “A-list”) and a list of device guidance documents that the agency intends to publish as the agency's guidance development resources permit each fiscal year (the “B-list”).

In addition to posting lists of prioritized device guidance documents, the FDA has committed to updating its website in a timely manner to reflect the agency's review of previously published guidance documents, including the deletion of guidance documents that no longer represent the agency's interpretation of, or policy on, a regulatory issue and notation of guidance documents that are under review by the agency. Fulfillment of this commitment will be reflected through the issuance of updated guidance on existing topics, removal of guidances that that no longer reflect the FDA's current thinking on a particular topic, and annual updates to the A-list and B-list.

The agency's announcement advised that the priorities of the FDA and CDRH are subject to change at any time. Topics on this and past guidance priority lists may be removed or modified based on current priorities and newly identified public health issues, as well as special control documents that are necessary for the classification of de novo devices.