On January 19, 2010, the FDA released its much anticipated action plan intended to streamline its 510(k) clearance process. The plan contains 25 action items the FDA plans to initiate this year.
Approximately 3,000 to 4,000 510(k) applications are submitted to the FDA each year, which represents about 90 percent of all approval applications received annually. However, the review process has not been updated since its creation 35 years ago through the Medical Device Amendments of 1976. To answer concerns raised by FDA staff as well as by stakeholders and consumers, in September 2009 the FDA established both an internal and external review process, allowing myriad opportunities for public input. The resulting preliminary report was published for public comment in August 2010 and contained 55 recommendations. After taking the public’s additional input into consideration, the FDA decided to:
- implement 23 of these recommendations
- defer action on seven of the more controversial recommendations until the Institute of Medicine (IOM) completes its own analysis
- hold a public meeting in April 2011 to seek additional feedback on two others regarding the scope of publically available information
Many of the actions, such as issuing draft guidance and proposed rules, will allow for further public comment throughout the year.
The IOM’s report is expected to be published this summer. Once released, the FDA will need to decide how to proceed on several of the more challenging issues raised last August: defining the scope of its rescission authority and when to use it; whether to establish a IIb classification requiring PMA-like data; or redefining “intended use” to allow the agency to directly regulate off label use.
Industry and Consumer Concerns: Competing or Congruent?
FDA’s action plan attempts to respond to what are perceived to be two competing concerns:
- industry concerns that the lack of predictability and consistency in the 510(k) process creates a drag on clearance times, dampens investment, stifles innovation and sends business overseas
- consumer concerns that the review process is not robust enough or data-driven to protect public safety
However, the responses to these two sets of concerns do not have to be mutually exclusive. Rather, the FDA’s goal is to make the 510(k) process more transparent and predictable, while continuing to ensure the public’s health and safety. This proactive agency’s articulation of clear, consistent data requirements will likely trend towards the adoption of more stringent and challenging standards to be met by industry.
In the January 19 press briefing, the Center for Devices and Radiological Health (CDRH) Director Shuren highlighted some of the major actions that will take place this year, including:
- streamlining the underutilized de novo classification process to make it less burdensome for developers of innovative, lower-risk devices
- providing the industry with clear and consistent information regarding data requirements and submission timing in order to reduce time and cost
- creating an internal Center Science Council to respond to new scientific information and periodically audit the 510(k) process, as well as an external network of experts to leverage external scientific expertise to assist FDA staff in adapting to increasingly complex technology
While the device industry awaits the release of the IOM’s report, companies should be poised to engage in FDA’s rulemaking and guidance processes.