FDA and Medical Devices:
After 20 Years, a Look Back, a Look Ahead

FDA has just marked the 20th anniversary of the Medical Device Amendments to the Food, Drug, and Cosmetic Act.

Until 20 years ago, FDA was ill-equipped to protect Americans from dangerous or useless medical devices, because the agency had to prove a device was unsafe or ineffective before it could take action to remove the device from the market. In 1976, the landmark Medical Device Amendments were signed into law by President Gerald Ford. The law requires manufacturers of most medical devices--particularly moderate- or high-risk devices--to provide FDA with safety and effectiveness data before marketing.

FDA's Center for Devices and Radiological Health is charged with implementing the device law. The center has many functions, including working with FDA's field force to inspect device manufacturing plants; keeping track of problems with devices already in use and taking prompt action to correct them; and helping manufacturers produce better products by conducting laboratory research on the ways companies test their products and on specific device safety problems.

One of the most visible and important functions of the center is to review devices for safety and effectiveness before they are marketed. The center clears for marketing everything from contact lenses and artificial joints to x-ray machines. More than 550 categories of low-risk medical devices, including surgical gloves and therapeutic massagers, are exempted from premarket approval.

Challenged to speed product approvals without compromising consumer safety, the center has made some changes in the way it does business. (See "Inside FDA: Agency Changes Include Medical Device Review" in the November 1996 issue of FDA Consumer.)

In the following interview, center director D. Bruce Burlington, M.D., talks about what the medical device program has accomplished and what remains to be done.

Q. Twenty years have passed since enactment of the landmark Medical Device Amendments of 1976. Are Americans better cared for as a result of the amendments?

A. I think the American people are significantly better off for having the medical device law. Today, Americans can really rely on devices. When a medical device is used in a doctor's office or hospital, patients can be confident that the operator knows how to use the device well and that it will work for them.

Americans can count on devices because of the system of pre- and postmarket oversight made possible by the 1976 amendments. To ensure that products are well-manufactured, FDA inspects companies to see that they are following good manufacturing practices, keeping appropriate records on the design and manufacture of products, and maintaining a system for handling complaints.

Before a product even goes to market, a company must present data to FDA showing not only that it will be well-manufactured, but also that it is safe and effective--that it won't harm people and will deliver its expected benefits. And if a product causes unforeseen problems, there's a feedback loop, a requirement that manufacturers report any serious problems to FDA so rapid action, including a product recall if necessary, can be taken to protect people from a faulty device.

There is yet another vital benefit of our regulation of devices under the medical device law: information. The largest source of risk in using a medical device isn't the product itself, but the interface between the user and the device. It is especially important for doctors to know how and when to use the product. Serving as a reliable, unbiased evaluator of this information may be the most important service FDA can provide to health professionals.

Q. What are some of the most significant accomplishments of the center during your service as director to date?

A. Several breakthrough devices have been approved by the center. One of the most important is our recent approval of the use of implantable defibrillators to prevent sudden death in people who have had heart attacks. This was the first approval for this use in the world, and it should save thousands of lives each year. Also in the area of cardiology, we approved a coronary stent, a cage-like device that's permanently implanted in a diseased coronary artery to expand it and allow normal blood flow. This is really changing the way cardiologists are performing balloon angioplasty to open up clogged arteries feeding the heart, making the procedure available to many patients who before would have had to undergo major surgery.

To help detect cervical cancer more reliably, we've approved a device that scans all pap smears read as normal by the technologist and identifies suspicious ones for a second review.

Also, we've approved a new microwave device to treat symptoms of enlarged prostate, a condition affecting millions of men. This device gives patients an alternative to treatment with drugs or surgery.

Two newly approved devices can potentially help millions of women who suffer from urinary incontinence. One is a disposable balloon-type device that the patient inserts into her urethra, and the other is an adhesive-backed foam pad that's placed over the urinary opening.

Another approval that's been prominent in the news is the use of excimer lasers to treat certain cases of nearsightedness, giving many people an alternative to eyeglasses or contact lenses.

An additional major accomplishment has been the center's recent emphasis on clinical trials--controlled studies in humans--for evaluating the safety and effectiveness of new devices. For 20 years, we'd been concentrating primarily on assuring that devices were well-designed and well-made. It goes without saying that these things are still important. But we've come to realize that for some devices--probably less than 10 percent--we also need clinical data from human studies. This gives us information on how the device will perform in actual patients, and gives the physician information about which patients are likely to benefit from the device and under what conditions. In the long run, I think the focus on clinical trials may have a bigger impact on the public than anything else we're doing.

Q. Government agencies are often criticized for making decisions that don't reflect the interests of the public and the regulated industry. Has FDA taken steps to avoid this pitfall?

A. Yes. To help the agency make decisions on policy matters or on specific devices, we want input from the public and industry. For policy issues, we often have grass-roots meetings--we've had several in the last year--to get suggestions on how to approach an issue. When we have a particular device in front of us that may be ready for marketing, very often we will have an advisory committee meeting. Most meetings are open, and consumer protection groups and members of the public are welcome to attend and tell us what they expect.

Because I also work as an emergency room physician, I get an additional, hands-on perspective. I can see the devices in action and can learn from patients and other physicians what they expect from the devices and from government oversight. It helps me to know which issues are peripheral so I can focus on the issues that really make a difference.

After balancing everyone's input, and with the intent of the law foremost in mind, FDA is ultimately responsible for deciding whether to allow a product on the market and whether it's necessary to take action against a product already on the market. In the end, the government official charged with making the decision is accountable to the public, and he or she must "take the heat" if a decision is criticized.

Q. Some critics say FDA is too slow in approving medical devices. Is the criticism justified, and what is the agency doing to speed up Americans' access to safe, effective medical devices?

A. We should take seriously those critics who raise valid points, and use their negative appraisals to improve our performance. We at FDA have to understand that new products do bring real benefits, and that delaying availability of a safe, effective medical device can harm people just as much as approving a faulty product.

At the same time, we must bear in mind that our goal is not simply to get products to the market, but to get products that work and that we know how to use. So we can't lose sight of our consumer protection mission as we look at changing the way FDA does business.

A little over three years ago, when I came to the center, we had a mountain of work that had built up over the previous couple of years. We had been through a period of incredibly intense internal scrutiny and external review, and we responded to that review by modifying the way we operate.

We've substantially dug out from under the mountain. Abbreviated applications--applications for a device that's essentially the same as something already on the market--are reviewed on time, usually within 90 days. For more complicated applications, we still have some work to do. We're making real headway, though, towards a record of timeliness.

Some people question whether patients in other countries get access to new devices sooner than patients in the United States. When it comes to products that are really new--those that represent breakthrough technologies or are the first of their kind--we use a system of expedited review which allows these kinds of devices to go to the head of the queue and receive review very quickly.

Under this system, we've approved several significant new devices in the past few years before they were approved anywhere else in the world. These include a prenatal test for genetic abnormalities, an ultrasound system to speed the healing of bone fractures, a bone growth stimulator for treatment of old, unhealed fractures, and the use of an implanted heart defibrillator to prevent sudden cardiac arrest in patients who have suffered heart attacks.

Of course, we have little control over the time it takes for a company to develop its product and collect data on its safety and effectiveness. But the next step--the company's interaction with FDA--must be productive and efficient. Long, drawn-out decisions aren't necessarily better than prompt ones. We at FDA need to make timely decisions to provide a clear and predictable business climate so that industry can do its job and bring new products to market. But we can't make sacrifices in the quality of data.

Complete, well-prepared applications move through the system more quickly than others. Once we have the good science necessary to make a decision, we should go ahead and make it, to reach closure on the issue and move on. That culture of decisiveness is especially important when we're dealing with the device industry, in which a product's market life often is only a few years.

FDA is committed to doing the best we can with the budget provided. By looking to the experience of businesses across America, we can learn lessons about how to get our job done better and more cheaply.

To make the most efficient use of FDA's resources, we're looking for ways to get the same results with fewer people. The agency has really pushed the envelope regarding abbreviated device applications. We're allowing many products that previously would have required a comprehensive application to now be reviewed under an abbreviated application, which is usually processed in only 90 days.

Also, we're pilot-testing a program of third-party reviews, which asks, "Which part of the work does it make sense for the agency to turn over to external parties?" We may be able to reduce review times by allowing carefully selected outside groups to perform the first stage of review of devices that don't present a substantial risk to the American public.

Q. Is it realistic to think that device regulation could be standardized worldwide to lessen the burden on device manufacturers who want to market their products internationally?

A. Today, medical device manufacturers may have to develop different sets of data for each country in which they seek approval. We are working toward harmonizing standards among countries where we can.

People are much the same around the world, and many of their diseases and injuries are the same. We ought to be able to reach agreement worldwide on what constitutes a safe, well-manufactured product. But the issue of whether a product delivers a sufficient benefit is harder because there are different expectations of the regulatory systems in the United States and, for example, Europe.

The United States has the gold standard for what is expected from companies when they want to bring a product to market, a gold standard not just in terms of knowing how a product is made but also of knowing how it works and under what circumstances it works. In Europe, device regulation focuses on whether devices are well-designed and well-made--their mechanical performance characteristics. It doesn't focus on efficacy--on whether the device works on patients--like our system does. We're not prepared to take a step down to a lower standard, and other countries with different expectations of government aren't ready to line up with the American system. So we don't expect to see total harmonization soon, with one reviewing body getting the product to the world market.

Q. What are the biggest challenges you expect your center to face over the next decade?

A. We have many of the same challenges that people have across government. Given the realities of the federal budget, we have to figure out how to get our job done with tight resources. We have to determine what's most important about what we do, and, where possible, share the public health responsibility with industry, academia, and health-care providers. We've already begun that process through the pilot testing of third-party reviews.

Also, in the last few years there's been a shift from the one-on-one, individual doctor and patient model of health care toward a managed care model where patient care is administered by large organizations like HMOs. With cost-effectiveness considerations playing a much larger role in medical decision-making, health-care organizations will need information for "technology assessment"--information not only on whether a device works, but how it compares to other devices and other forms of treatment.

In some ways this will make FDA's job easier, because every company that wants to market a product will know that its data will not only have to pass review by the agency, but will also have to convince the managed-care organizations that its product really makes a difference.

But this raises questions about FDA's role in this new era. Are we going to continue to evaluate each new device essentially in isolation, simply asking whether the product works and is safe, leaving it to others to do the comparisons? Or will the agency jump into the technology assessment arena? More and more, I think we'll have to focus on how to evaluate products in the context of the whole health-care picture.

Tamar Nordenberg is a staff writer for FDA Consumer.