Business is back to normal — or close to normal — for the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) tasked with reviewing and clearing all medical devices. But while the center is operating, stakeholders need to recognize that the impact of the 16-day shutdown will be felt for some time to come, detracting from normal operations.
Like other components of the FDA, CDRH was never completely shuttered, with about 55 percent of staff on duty over the past few weeks, though not always in their normal position. Throughout this time, CDRH continued to process device applications submitted before October 1 using user fees, meaning most PMAs, supplemental PMAs and 510(k) applications already in the queue continued being processed. Likewise, most IDE reviews and major public health related inspections and enforcement actions continued.
A number of major center activities were placed on hold. Now that the center is reopened, CDRH will continue to address critical public health issues and will concentrate on submissions, seeking to maintain MDUFA target goals. From there, the center will move to lower priority tasks such as MDR reviews and guidance development. Here are some more details of the restart:
For medical device manufacturers, the most visible impact of the shutdown was the inability of CDRH to accept any new user fee-based submissions. Many companies continued to file PMAs and 510(k)s that sat in the document room untouched. With full staff back, CDRH is rapidly processing these applications into the normal review systems with normal review activities expected to kick in within days.
The backlog means CDRH will be facing a bolus of submissions with essentially identical deadlines. While there may be some dislocations, CDRH is predicting that there will be no major deviations from recent approval timelines. Companies that did submit applications during the shutdown should consider confirming that the submission was received, that user fees have been processed and properly allocated, and that the review has started.
Many post-market activities were put on hold as non-essential. Routine post-market tasks such as MDR assessments and the review of post-market reports will be in a catch up mode. We anticipate slower action and communications in this arena for the near future as CDRH concentrates on higher priority tasks. Stakeholders should not, however, assume public health issues will not remain as high priorities. CDRH will still be concentrating resources on Class I recalls and significant public health questions.
Regulatory Development and Legislative Matters
CDRH has a significant number of ongoing regulatory development activities, policy initiatives and legislative reports. We anticipate that there will be a delay in some of these activities, including the review of comments on past Federal Register notices. Statutory requirements and high profile guidances (e.g., modifications and recall processes) will likely be prioritized.
Additionally, a scheduled House Energy and Commerce Committee hearing on FDASIA implementation and oversight hearing was postponed due to the shutdown. We anticipate that this hearing will be rescheduled and held before the end of the year, and the impact of the shutdown on MDUFA goals and statutory requirements will undoubtedly be a topic.
Shortly before the shutdown, Commissioner Hamburg announced the creation of the Program Alignment Group (PAG) that was charged with rethinking FDA organization and processing. The PAG effort seems to be delayed due to the shutdown. International harmonization efforts may also suffer from decreased time and resources, and travel ability may well continue to be constrained — impacting CDRH's ability to participate in conferences and programs around the country.
Of course, the agreement to fund the government is temporary and expires on January 15. If Congress is unable to reach an agreement to replace the cuts under sequestration, CDRH will need to plan to work with even less funding as another round of cuts is scheduled to take effect.
Further budget cuts, another shutdown or even the resources required to plan for a shutdown will strain CDRH financial and human resources. These future budget uncertainties will be the major determinate of whether CDRH will be able to meet MDUFA goals and implement its current process improvement initiatives.
While some key players in Congress introduced legislation earlier this year to exempt FDA user fees from the sequestration, the legislation has yet to move. If Congress is unable to reach a sequester agreement, device and other stakeholders may redouble their efforts to advance that legislation. According to the Medical Device Manufacturers Association, CDRH lost about $2.9 million in user fees and about $16 million in total fees under sequestration. Future cuts along the same lines would clearly have a significant impact on center activities.