This week, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced new actions for the 510(k) program, the most commonly-used pathway to market for medical devices. The FDA’s CDRH uses this program to clear some 3,000 new medical devices for patients each year.
Prior to announcing the new actions, President Obama wrote an editorial in the Wall Street Journal asserting that the changes would result in “getting innovative and life-saving products to market faster.”
CDRH Director Jeffrey Shuren, M.D., J.D. told the public in a letter that the new 510(k) actions will increase the predictability, reliability, and efficiency of FDA’s regulatory pathways to help provide better treatments and diagnostics to patients more quickly, stimulate investment in and development of promising new technologies to meet critical public health needs, and increase the global market position of U.S. medical devices.
Background
In September 2009, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making were formed to address critical challenges facing the CDRH and external constituencies.
Industry had raised concerns that the 510(k) program had become less predictable, consistent and transparent thereby stifling innovation and sending companies and jobs overseas, and that CDRH reviewers had become less responsive and more risk averse. Dr. Shuren noted that “an unpredictable environment discourages investment and stifles innovation, which, in turn, can spur companies to go overseas.”
Consumers, third-party payers, and some healthcare professional groups were concerned that, for some devices, the 510(k) program did not provide adequate assurances of safety and effectiveness nor did it provide sufficient information for healthcare providers and patients to make well-informed treatment or diagnostic decisions.
CDRH employees expressed concerns that the current 510(k) program failed to adapt to the increasing complexity of devices, and that reviewers’ ability to make well-informed decisions was undermined by the poor quality of 510(k) submissions. In addition, an increasing workload was straining an already overburdened program.
In August 2010, FDA’s CDRH released for public comment the preliminary reports from these committees.
510(k) New Actions
According to the FDA’s newly released actions, to facilitate innovation in medical devices, the FDA will:
- Streamline the review process for innovative, lower-risk products, called the “de novo” process;
- Publish guidance for industry to clarify when clinical data should be submitted to increase predictability and transparency;
- Develop a network of external experts who can use their knowledge and experience to help the agency address important scientific issues regarding new medical device technologies;
- Establish a new Center Science Council of senior FDA experts within the agency’s medical device center to assure more timely and consistent science based decision making; and
- Improve training for CDRH staff and industry
While no medical device is completely risk-free, the FDA is strengthening its capacity to assess medical devices and monitor their safety once they are on the market and being used. To bolster the safety of medical devices, the FDA will:
- Establish a public database of important device information, such as medical device labeling and summaries of the basis for the FDA’s decision to clear specific devices; and
- Require a brief description of scientific information regarding the safety and effectiveness known to the manufacturer for select higher-risk devices on a case by-case basis through device-specific guidance.
FDA also released an implementation plan that outlines 25 specific actions and the timelines for completion or reaching a major milestone in 2011 to make the 510(k) program a blueprint for smarter medical device oversight; one that drives innovation and brings important technologies to the public.
For some of the 25 Action Items listed in the chart, there will be additional opportunities for the public to provide input, where appropriate. Recommendations that are regulatory actions –such as draft guidance’s and proposed regulations – will have their own individual comment periods to give interested stakeholders an opportunity to comment on the draft proposals before they are finalized.
FDA will also have a Public Meeting from April 7 – 8, 2011, on the White Oak, Maryland campus to solicit feedback and discuss the implementation of two recommendations: the public posting of device photographs and the development of an online labeling repository. Lastly, CDRH may issue device-specific guidance on:
- When and what type of manufacturing data to submit
- When a pre-clearance inspection would be conducted
- When and what types of modifications should be periodically reported in lieu of submitting 510(k) or
- When and what type of safety and effectiveness information for the device to be reviewed that is known to the manufacturer should be submitted as a brief description.
These guidance’s however are on a case-by-case basis, and there is no timeframe for taking action as of now. FDA said it will post updates on the status of planned actions on CDRH’s website.
Issues to Be Referred to the Institute of Medicine
FDA received comments on seven of the recommendations that stakeholders found problematic. As a result, FDA is giving the Institute of Medicine (IOM) an opportunity to provide feedback as part of its independent review of the 510(k) program before FDA makes a final decision. Should the IOM offer comments FDA will take them into consideration. The recommendations are as follows:
- CDRH should consolidate the terms “indication for use” and “intended use” into a single term, “intended use”;
- CDRH should expand its statutory authority to consider off-label use when determining the intended use of a device;
- CDRH should issue guidance on when a device should no longer be available for use as a predicate;
- CDRH should issue a regulation on its rescission authority;
- CDRH should require manufacturers to keep one unit of a device available;
- CDRH should issue guidance to create a “Class IIb”; and
- CDRH should seek greater authorities to require postmarket surveillance studies as a condition of clearance for certain devices.
Discussion
As the Wall Street Journal noted, the 510(k) changes announced by FDA made key concessions to device makers by putting off several proposed rules that drew fire from the industry. Companies particularly objected to proposed rules that would have enhanced the FDA’s authority to revoke approval of devices and strengthened the agency’s ability to force manufacturers to conduct post-market safety studies.
Both proposals were among the seven that didn’t make the final cut.
While the 510(k) changes appear to show positive changes for the medical device industry that promote innovation, implementing these changes will take some time, as noted by FDA’s implementation plan. Additionally, as FDA and the IOM consider other proposals and recommendations, uncertainty about other provisions may still cause device makers trouble in predicting future approval and receiving funding and investment.
Nevertheless, it would appear that FDA’s process of listening to the public, industry, and a number of policymakers have paid off for the device industry. The new actions released by FDA show a willingness and commitment of the agency to continue encouraging innovation so that America can remain a leader in medical innovation and technology and citizens can continue to have access to the latest devices, while still guaranteeing safety and effectiveness.
If America wants to lower health care costs and bring better quality and efficiency to our health care system, developing newer medical devices and technologies will be an effective way at achieving this goal. Moreover, now that FDA has given more certainty to the medical device approval process, federal health agencies, academic medical centers, and health institutions should promote more ways for industry and the public to collaborate in bringing new technologies and medical devices to the public.
Moving forward, Congress and policymakers need to provide FDA with adequate resources, funding and support to ensure that these initiatives are successful and maintained so that innovation and medical technology only increases.