FDA’s Center for Devices and Radiological Health (CDRH) sent a notice to industry, indicating that it is soliciting feedback regarding the development of future guidance documents and the prioritization of those guidance documents.
On June 5, FDA hosted Center for Devices and Radiological Health Guidance Development and Prioritization Public Workshop. The topics discussed included CDRH’s guidance development process, guidance development best practices for FDA, CDRH and CDRH stakeholders, and CDRH guidance priorities and priority development. A copy of the event’s webcast can be found in three parts (1, 2, 3).
Questions regarding workshop content can be sent to Cathy Norcio from FDA’s CDRH at 301-796-5446 or Catherine.Norcio@fda.hhs.gov. Additionally, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is July 7, 2014.
As reported by the Association for the Advancement of Medical Instrumentation (AAMI), the workshop, which took place at the FDA’s White Oak Campus in Silver Spring, MD, brought together a number of stakeholders to discuss the challenges and opportunities presented by the guidance development program.
“The guidance program is, and I suppose always will be, very controversial,” noted Nancy Stade, Deputy Director for Policy at CDRH. Despite the controversy, the FDA wants “folks to feel as if they understand the guidance development process a little bit better,” as result of the workshop, said Stade.
AAMI’s reporting of the event continues with several interesting quotes. “Guidance development is misunderstood,” said Ruth Fischer, policy advisory [sic] at CDRH. “We can always do better,” she added.
“Why is there a desire to sit down one-on-one?” asked Leslie Kux, assistant commissioner for policy at the FDA, who added that the agency strived for transparency by allowing the public to read all comments submitted to dockets. Kux is not averse to alerting stakeholders if a guidance of interest is available—something the agency does—she doesn’t want nontransparent private meetings with groups.
Of interest to our readers, many of whom may not be familiar with the FDA’s guidance process, Kux’s presentation included a conceptual map explaining the agency’s steps
Also discussed was FDA’s treatment of draft guidances as opposed to their final versions. This issue has drawn concern from members of the Senate Committee on Health, Education, Labor, and Pensions (HELP). Members sent a letter to FDA Commissioner Hamburg, expressing concern that the agency was using draft guidances to make substantive policy changes.
“Stakeholders tell us that draft guidances are increasingly becoming default FDA policy and position,” according to the letter, signed by Sens. Lamar Alexander, R-TN, Johnny Isakson, R-GA, Richard Burr, R-NC, and Orrin Hatch, R-UT, and available at the FDA Law Blog. “Draft guidances state that the ‘guidance document is being distributed for comment purposes only.’ However, in the absence of finalized guidance, drafts are the only information that FDA review staff, patients, clinicians, and FDA-regulated entities have on the agency’s most current thinking on important issues.”
The group asks the FDA to provide several pieces of information, including agency-wide efforts “to make the finalization of guidance more efficient and expeditious.”
In terms of relying on draft versions to make regulatory and enforcement decisions, McFarlane said: “We don’t do that.” He said if someone has run into that situation, to contact him or the CDRH ombudsman.