CDRH Issues its Strategic Priorities for 2012January 29, 2012
On Tuesday, January 24, FDA’s Center for Devices and Radiological Health (“CDRH”) released its strategic priorities for 2012: (1) fully implement a total life cycle approach; (2) enhance communication and transparency; (3) strengthen the CDRH workforce and workplace; and (4) proactively facilitate innovation to address unmet public health needs. Though the priorities have remained consistent over the last three years, the strategies and goals (sometimes) differ. This blog post addresses some of the highlights.
Total life cycle approach. This is the most comprehensive and aggressive of the four priorities. Perhaps most ambitious is CDRH’s goal to finalize all guidance documents issued as part of the plan to improve premarket programs. Given the number of draft guidance documents issued in 2011 for this purpose (approximately 11), it is unlikely CDRH will achieve this goal, nor, perhaps would it be advisable to do so. While final guidance is helpful to industry, in this case, rapid finalization would likely mean that CDRH did not take the time necessary to consider and address all the comments submitted by stakeholders or consider the relationship between the various documents. Rather than striving to finalize all guidances, CDRH should focus on those likely to have the biggest impact: those regarding benefit-risk determinations, the 510(k) paradigm, appeals, and when to submit a 510(k) for modifications to currently marketed products.
This priority also proposes implementing a knowledge management strategic plan and a Center-wide quality assurance program. It is not clear what role these proposals will play in day-to-day operations of the Center, or what issues they are intended to address.
A repeat goal is to enhance compliance capability by implementing its “business-case-for-quality” (in 2011 this was referred to as “Case for Quality”), though the sub-goals are different. In 2011, this goal was to be completed by September 30, 2011. In the 2012 priorities, CDRH will begin to implement the program by December 31, 2012. Precisely what this initiative will entail is not clear from either the 2011 or 2012 language.
Enhance communication and transparency. Given the importance of improving communication and transparency with industry, it is surprising that this priority has only two rather thin strategies and goals. One goal (a repeat from 2011) is to continue taking “steps to strengthen information exchange and improve gathering feedback” from external constituencies. It seems that industry’s concern is less about CDRH’s ability to gather feedback, and more its failure to adequately respond to the feedback it receives and its shortcomings in communicating with companies.
Strengthen the workforce and workplace. This priority emphasizes employee training and education, and enhancing effective leadership, all of great importance to industry. Hopefully, training “to enhance premarket reviewer knowledge of how medical devices are designed, manufactured, and utilized” will allow for a better, more realistic understanding of devices by reviewers.
The proposal “to provide CDRH managers and supervisors information and tools to assure effective leadership” has the potential to, for instance, encourage supervisors to work with reviewers to understand the boundaries of requests for additional information and to provide better guidance to staff. Hopefully, it will also empower supervisors to overturn a subordinate’s decision when appropriate.
Proactively facilitate innovation to address unmet public health needs. Innovation, and FDA’s role in its facilitation, is a “hot topic” in medical device regulation and reform. Though the first strategy within this priority is the same as 2011—to foster the development of innovative medical devices—there are far fewer goals to implement this strategy in 2012 than there were in 2011. The only goal in 2012 is to “create processes and tools that will improve the pipeline for innovative medical devices and transform the way CDRH works with medical device innovators.” While this is a laudable goal, it lacks any specifics. Until the review processes are more transparent and predictable, and review times are shortened, it is likely also an unrealistic one.
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