FDA review of devices has been riddled with growing controversy over the last year and now it has culminated with the decision to formally assess the process.

For more than three decades, the FDA review process for medical devices has delineated between a more rigorous review of certain technologies thought to pose significant risk to people, known as premarket approval (PMA), and a less stringent appraisal, via the 510(k) process, called premarket notification.

The fact that the 510(k) process is old, accusations that products have been approved without enough scrutiny along with alleged inappropriate decision-making within the agency are all at the root of oncoming inevitable changes.

So now the FDA has commissioned the Institute of Medicine (IOM; Washington) to study the 510(k) process. It's no surprise, especially since some of the thousands of medical devices cleared via the 510(k) classification blur the lines when it comes to their potential impact on humans.

Although the Advanced Medical Technology Association (AdvaMed; Washington) said that it favors the review, a spokeswoman for the group indicated she has confidence in the current system, even saying that it offers "robust protection to Americans."

"AdvaMed believes the 510(k) process is a well-defined, objective and science- and risk-based regulatory process," Janet Trunzo, executive VP of technology and regulatory affairs for AdvaMed, told Medical Device Daily.

When asked if newer technologies are blurring the lines of distinction between the different classes of devices, she said, "FDA has well-established criteria for determining the classification of a device. If a newer technology has different technological characteristics that raise new issues of safety and effectiveness compared to an already marketed predicate device, it cannot be cleared through the 510(k) process."

In addition to the IOM study, the FDA's Center for Devices and Radiological Health (CDRH) will convene an internal working group to evaluate and improve the consistency of FDA decision-making in the 510(k) process.

"Good government conducts periodic reviews and evaluations of its programs," said Jeffrey Shuren, MD, acting director of CDRH. "Our working group and the IOM's independent evaluation will help us determine how the 510(k) process can be improved to better support FDA's mission to protect and promote the public health."

These moves to take a closer look at the review process follow last month's resignation of Dan Schultz, MD, CDRH director, who left amid controversy related to several 510(k) approvals. One of those was the approval of the Menaflex 510(k) application by ReGen Biologics (Franklin Lakes, New Jersey).

The fact that Menaflex, a collagen scaffold for use in patients who have had a partial removal of the meniscus, was reviewed via the 510(k) rather than a PMA raised eyebrows.

Legislators have even jumped into the fray, highlighting the need for closer inspection of the device review process. Three members of the House, led by Henry Waxman (D-California), chairman of the House Energy and Commerce Committee, wrote a letter to the FDA stating that "given the questions raised by the FDA scientists about the lack of data on the safety and efficacy of this device (Menaflex), we believe this is a prudent course of action" referring to their intention of further investigating potential inappropriate actions related to the approval. The other two letter signers were Frank Pallone (D-New Jersey), chairman of the health subcommittee, and Bart Stupak (D-Michigan), who chairs the committee's subcommittee on oversight and investigations (MDD, May 13, 2009).

It's also been rumored that the lawmakers are drafting legislation that would curtail the 510(k) program (MDD, Aug. 31, 2009).

Additionally, some disgruntled employees earlier this year sent letters to congressional leaders and the Obama administration that named the director of the Office of Device Evaluation, Donna-Bea Tillman, PhD, in allegations that she and Schultz placed relations with industry over safety considerations.

With a budget of $1.3 million for the project, the IOM will address these questions:

Does the current 510(k) process optimally protect patients and promote innovation in support of public health?

If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?

The review is set to be completed by 2011 at which time the IOM will report its findings and recommendations.

In addition to the questions put to the IOM, Shuren said the CDRH will also

Create a task force on the use of science in regulatory decision-making.

Develop an effective compliance strategy.

Optimally integrate premarket and postmarket information.

Increase transparency in decision-making.

Establish clear procedures to resolve differences of opinion.

AdvaMed has also suggested that IOM's study committee should include individuals who are experts in the medical device innovation model and regulatory process.

The original 510(k) process was established under the Medical Device Amendments of 1976. The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require PMA for devices such as heart valves and intraocular lenses.

Class I and Class II devices are said to pose lower risks and include devices such as adhesive bandages and wheelchairs. Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require PMA.

The effort to rein in the device review process started earlier this year, when the FDA reported that manufacturers of 25 types of medical devices marketed before 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency's most stringent PMA process (MDD, April 10, 2009).

Assuming all of this culminates in a more stringent review process for devices that may have previously gained approval via 510(k), the added complexities of a PMA review could bring added burdens and costs to device makers.

When asked if she thought such a change would put a damper on innovation, AdvaMed's Trunzo declined to say yes or no. Instead, she told MDD, "The 510(k) process is a well-defined, science-driven method used by FDA as part of a comprehensive regulatory framework to meet the needs of patients and the diversity of medical technology."

Lynn Yoffee, 770-361-4789;

lynn.yoffee@ahcmedia.com