FDA Unveils Some Proposals for 510(k) Reform, Delays Most Controversial Actions

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Medical device regulators at the Food and Drug Administration Jan. 19 unveiled a plan containing a number of actions the agency intends to implement during 2011 to improve the 510(k) premarket notification process.

However, the agency put off making recommendations on issues that spurred resistance from stakeholders.

Generally, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device (called a predicate device); it is less stringent than the premarket approval process used for highest-risk devices. The 510(k) process is the most common pathway for medical devices to reach the market.

Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH), outlined 25 actions the agency will take that will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly. ”

Shuren said FDA would implement changes such as streamlining the “de novo” process for lower-risk devices, clarifying when clinical data should be submitted in a 510(k) submission, and creating a new science council of senior FDA experts to assure timely and consistent science-based decisionmaking. Other changes include new guidance and enhanced staff training, FDA said.

The latest actions are part of the agency's internal review of 510(k) that was begun under the Obama administration.

Waiting for IOM Recommendations

FDA said it deferred taking action on seven of the most controversial recommendations until the Institute of Medicine completes its own review sometime this summer. Those actions are:

• FDA's authority to rescind a 510(k) clearance;

• establishing a class “IIb” of devices that would require clinical evidence;

• greater authority to require surveillance studies after marketing clearance, as a condition for clearance;

• clarifying when a device should no longer be available for use as a predicate;

• consolidate the concepts of “indication for use” and “intended use” into a single term, “intended use”;

• consider requiring each 510(k) submitter to keep at least one unit of the device under review available for review by CDRH officials; and

• explore the possibility of pursuing a statutory amendment that would provide the agency with the express authority to consider an off-label use when determining the “intended use“ of a device.


Predictability, Efficiency.

The changes will serve to increase the predictability, reliability, and efficiency of the agency's regulatory pathways, Shuren said.

However, Shuren said FDA will wait until the Institute of Medicine (IOM) completes its own independent review, set to be released this summer, before it makes recommendations on seven of the most controversial changes to the 510(k) program that were among the 55 total recommendations the agency released in August 2010.

Shuren said the agency will give IOM time to weigh in on recommendations that drew “significant concerns” from industry stakeholders, including FDA's ability to rescind a 510(k) clearance as well as the establishment of “class IIb” devices that would require clinical evidence for approval (class II includes moderate risk devices, while class III is the highest-risk class). He said the agency will take IOM's comments into consideration before deciding whether to act on the recommendations (see box).

The changes announced by the agency were previewed in an opinion piece written by President Obama in the Jan. 18 Wall Street Journal in which he called for a governmentwide review to remove outdated regulations. Obama said FDA's efforts would “keep patients safer while getting innovative and life-saving products to market faster” (see related item in this issue).

Mixed Reactions.

The device industry's chief trade group, AdvaMed (Advanced Medical Technology Association), had supported a number of the changes but lobbied against the most “disruptive” proposals that it felt would hurt innovation.

Stephen J. Ubl, president and chief executive officer of AdvaMed, in a statement called FDA's plan a step in the right direction.

“The plan is clearly a good first step that will address some of the major problems with the program, including improving consistency, providing greater reviewer training, and streamlining of the de novo process,” Ubl said. According to FDA, the de novo process is intended to apply to low risk products that have been classified as class III because they were found not substantially equivalent to any identifiable predicate device.

Ubl added, “The critical next step is how FDA implements the plan through guidances and regulations. Those details will determine whether today's proposed changes will improve patient access and American competitiveness.”

Mark Leahey, president and chief executive officer of the Medical Device Manufacturers Association (MDMA), told BNA he would have liked to see more specificity from the agency on what each proposed change would entail.

For example, the agency said it would issue a draft guidance on streamlining the de novo process, but offered no details as to how it would be streamlined, Leahey said.

“They identified areas that need work, but there's no more detail today than six months ago,” Leahey said.

Leahey said he remained concerned that FDA “deferred final decisions on key issues to the Institute of Medicine” instead of taking them off the table.

Consumer Group's Concerns.

But Diana Zuckerman, president of the National Research Center for Women and Families, said she was disappointed by both the “process and the outcome” of FDA's plan.

Zuckerman told BNA she felt the agency had made “a lot of good recommendations” in its August report, but the newest report indicated that the agency backed down in the face of “monied interests.”

Zuckerman said she understands the usefulness of the 510(k) process, but feels that too many high-risk devices have been getting cleared for marketing without appropriate scrutiny because of weak standards. She said she hopes FDA can succeed in strengthening the process, but its most recent plan “looked like a rigged election, not a scientific process.”

By Nathaniel Weixel

FDA's implementation plan is at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm and http://op.bna.com/hl.nsf/r?Open=nwel-8d9qbb.

FDA's original recommendations can be found at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm.

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