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Re-evaluating the Medical Device Approval Process

Earlier this year, a GAO report concluded that many high risk medical devices have not been adequately reviewed. In June, the House Health Subcommittee held the first of what may be a series of hearings on medical devices. The media appears increasingly interested in medical devices and is raising more questions.

All these events are a prelude to FDA and Congress undertaking a major re-evaluation of the product approval process for medical devices. It would be a relief if FDA could diagnose and treat its own medical device problems, leaving the Congress and the media to watch.

Whether FDA acts or Congress makes changes in law, I believe that the overall device approval process will change. Yet, it will still be recognizable to those who have worked with the 1976 Medical Devices Amendments, as further amended in 1990. During the re-evaluation process, every aspect of medical device regulation is going to be scrutinized as never before.

The stakeholders are likely to divide into two camps:

  • those who think the system is fine with a few tweaks, and

  • those who think a substantial set of changes are needed.

The final result is likely to be somewhere in between: more than a few tweaks, less than an overhaul.

There are multiple issues to address, such as device classification, post-market studies and surveillance, safety of devices, inspections, etc.

Setting the appropriate level of premarket review for a medical device is likely to be the most contentious issue. Under the Federal Food, Drug and Cosmetics Act (FDC Act), as amended, a device can be considered a class III device if it presents a high risk to patients and society or if it is based on a new technology. Class III devices are required to submit data on safety and efficacy to FDA. The sponsor can only market the product if FDA grants a Premarket Approval (PMA).

The vast majority of devices—including some class III devices–do not have a PMA. Some devices placed in class III under the FDC Act are based on a new technology and may not represent a high risk. In these cases, FDA may down-classify the device to class II, which are devices that represent a moderate risk.

Class II devices generally require a 510(k) Premarket Notification. Under the 510(k) process, a sponsor must show that a device is “substantially equivalent” to a device already marketed. The 510(k) is significantly less rigorous than a PMA and “substantial equivalence” has been broadly interpreted.

In April, the FDA responded to the GAO report by announcing that 25 types of class III medical devices will undergo safety and effectiveness review. After receiving information from sponsors, the agency will evaluate the risk level for each device type. Some of these devices are likely to become class II. Those devices found by the FDA to be of high risk to consumers will be required to submit PMA applications.

This makes me wonder: does FDA currently have the statutory authority to resolve most of the issues that surround the medical device approval process?

If so, FDA should evaluate issues, then act to solve any problems themselves. This would provide better assurances about the safety and effectiveness of medical devices, while avoiding the delays and drama that are inherent in the Congressional process.

This column is dedicated to the memory of Senator Ted Kennedy,

who was a champion of an effective FDA over many decades.


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