UPDATE: Industry reacts to proposed changes to 510(K) program

Industry leaders across the medical device landscape began to weigh in on proposed changes to the 510(K) premarket notification program Wednesday, with most expressing relief over the recommendations proposed by the Centers for Devices and Radiological Health.

“The proposals are more benign than many had feared. No radical change to the current process appears likely. ” Leerink Swann analyst Rick Wise wrote in an email to investors. “The concern here is that an already tougher and more demanding FDA might deploy new rules in a way that could make the approval process overall more transparent but also more burdensome.”

On Tuesday, CDRH officials released several recommendations for changing the 510(K) process, the program by which more than 3,000 medical devices are brought to market.

The recommendations are not official guidance yet as they will be open to public comment for 60-days, according to CDRH head Dr. Jeffrey Shuren, who spoke to members of the media in a midday briefing.

However, he said a majority of the proposed changes could be in place within ” a matter of months” if there is not widespread objections. Some provisions, however, might not go into effect until the second independent review of the 510(K) program being conducted by the Institute of medicine comes out in the summer of 2011.

Shuren said that the point of the changes were not intended to reduce the number of devices that use the 510(K) program, as many industry insiders feared would happen. He said the point was to create “a smarter 510(K) program,” and in fact many of the changes called for in the report were hinted at during a “town hall” style meeting with industry that took place in Massachusetts in June.

Among the proposed changes are:

• The creation of a new device class called “class IIb” devices, which will require manufacturers to provide some form of clinical evidence to prove effectiveness. Shuren said the evidence required would amount to a full clinical trial, which is currently only required for a PMA submission. Instead companies with devices in this new class group would be required to put the devices in the hands of the end users like physicians and nurses to determine if there are “design failures.” He anticipated that only about 8 to 10 percent of the current devices on the market would fall into the class IIb, but specifically named infusion pumps as one product that would be moved into the new group.

  In March, the FDA convened a panel to review the risks posed by the pumps, after 18 recalls were issued for the devices over a five-year period. The watchdog agency made its first moves toward stricter regulation infusion pumps in April, issuing proposed new guidelines advising manufacturers of the devices that they’ll likely have to run more in-depth clinical trials before the FDA clears new pumps.

  He added that the agency had heard numerous complaints from industry that the agency invesitgators were asking for clinical evidence from companies midway through a 510(K) review, which led to costly delays.

• The creation of a new Center Science Council to guide the agency in science based decision making, which will be chaired by William Maisel, a cardiologist at Beth Israel Deaconess Medical Center.

  Shuren said this group will serve as a “standing body,” responsible for overseeing science-based decision making across CDRH, provide regular audits decisions made by the agency and assess program performance.

  Maisel also serves as the founder and director of the Medical Device Safety Institute at BIDMC and is well known in FDA circles.

• The agency will issue clarification on its rescission authority to revoke 510(K) clearances and provide evidence whereby a device shouldn’t be used as a predicate device.

  Shuren said that the internal report revealed that 29 percent of the devices applying for a 510(K) clearance in 2009 cited devices that were no longer on the market. He said the agency must do a better job of making sure companies were using updated comparisons in 510(K) applications.

  In addition, the agency will be more transparent about the criteria it uses to revoke a devices 510(k) clearance. Maggie Dietrich. Special Assistant to the Commissioner said on the call the language in the current statute is not sufficiently clear, but that agency has “implicit authority” to revisit previous decisions and will seek to make it more transparent why a device was taken off the market.

  Shuren said that about 100 decisions on 510(K)’s have been reversed since the 510(K) program began in 1976.

The agency also listed several other recommendations including:

• Create better/quicker communications with industry through a new “notice to industry” tool to communicate changes in premarket expectations.
• Improving safety by requiring companies to provide up front to reviewers any scientific information known regarding the safety and effectiveness of the device. This is currently not required in the 510(K) program.
• Streamlining the premarket pathway for lower-risk novel devices by making major reforms in the implementation of the de novo process.
• Enhancing the science-based professional development for CDRH staff by providing better training, knowledge sharing and creating a network of external experts to keep staff informed of new developments in technology.
• Create a searchable online public database that provides more detailed, up-to-date information on the devices currently in the market.

The release of the two reports marks the end of a process started last fall when the agency announced it was conducting an internal review of the 510(K) program to find out whether the process protects patients and promotes innovation and what changes, if any, are needed.

“I think they made a very fair and balanced proposal here and hopefully it will provide the clarity that the industry and the investment community need,” Medical Device Consultants Inc. president William Morton told MassDevice. “Our clients have been frustrated because they know the rules are changing, but they don’t know what the new rules will be. This report helps to clarify the situation and the FDA’s expectations.”

Advanced Medical Technology Association CEO Stephen Ubl called the steps to improve the 510(k) process were “commendable” in a prepared statement.

“At the same time,” he added, “there are in excess of 70 proposed changes that, taken together, could result in a significant disruption to a program that has served patients well for more than 30 years. These range from potential changes in the fundamental basis for product clearance to publicly disclosing design schematics in a database where foreign competitors would have access to them.”

“[C]hanges should be targeted, have a corresponding public health benefit and not undermine a system that has a remarkable safety record,” he said.

To download an mp3 recording of Dr. Shuren disussing the proposed changes to the 510(k) process with members of the media, click here.