Frequently Asked Questions: Product Safety

Medical Technology Regulation

Q: How are medical technologies regulated?

Before ever reaching the market, advanced medical technologies are thoroughly evaluated for both safety and effectiveness. FDA's rigorous requirements cover the entire life of a new medical technology — from the very early design and development phases to years after a technology is helping physicians improve patients' lives. Manufacturers work with the FDA through the entire process to make sure they have the information needed to determine the safety and effectiveness of a technology.

Q: Do regulations differ based on the technology?

Individual medical technologies are as unique as the patients whose lives they improve. Responsible regulation must weigh product benefits against product risks. In all instances, upholding patient safety and improving patient lives come first. Recognizing the diversity and complexity of devices, the FDA tailored the review system to be appropriate for the individual device. This three-tiered system allows FDA to appropriately match the level of review with the individual device, and has become the model for medical technology regulation worldwide.

• Class I covers simple devices - like tongue depressors and thermometers - and generally do not need pre-market review. Class I devices pose a very low risk to patients and account for approximately 30 percent of all devices.

• Class II includes surgical instruments, patient monitors, catheters, and diagnostic imaging equipment like ultrasound and x-ray machines. These are proven technologies with well-known and well-understood safety profiles. They pose either a low or moderate risk to patients and therefore are typically approved with pre-market notifications (also known as 510(k)s). Manufacturers must show that Class II devices are "substantially equivalent" to other existing, legally marketed medical technologies, which have a proven track record in the marketplace. Most medical devices, about 60 percent, are Class II.

• Class III covers breakthrough devices such as artificial heart valves, coronary stents, novel diagnostic tests, bio-artificial skin, and spinal implants. Due to their breakthrough nature, Class III devices pose a higher risk to patients and must undergo an exhaustive approval process to ensure patient safety. They account for around 10 percent of medical technologies

Q: What additional safeguards are in place for the highest-risk devices?

Many breakthrough technologies are often first-of-a-kind devices that open new doors of treatment for those patients suffering from the most serious disease conditions.

Because innovation is not a risk-free process, FDA pre-market requirements for groundbreaking (Class III) medical technologies cover every aspect of product development — from design to bench testing to clinical trials to review of the data by the agency.

To ensure patient safety, manufacturers gather extensive clinical and preclinical data over many years at a cost of millions of dollars. FDA must review and approve this data, as well as other information on labeling and manufacturing processes, before the technology can be brought to market.

Q: Once the FDA approves a medical technology, what happens next?

The safety process does not stop once technologies are approved. FDA guidelines are the standard to be met, but our goals are set higher: moving people forward with the best science and technology.

Once the FDA approves a medical technology, companies follow strict manufacturing controls to ensure that the devices they produce will continue to be safe and effective throughout the entire lifespan of the device--from design to pre-production to full-scale production to long after being used by doctors to improve the lives of patients.

Robust post-market monitoring requirements are in place to allow manufacturers and the FDA to detect and identify unanticipated problems quickly, and address them effectively.

Medical technology companies tightly control each of these steps and continually collect information from patients and doctors to improve their processes and their products.

In addition, feedback from physicians and patients allow us to improve on current technologies and develop the next generation of innovation.

Adverse Events and Recalls

The medical technology industry and the FDA are committed to providing patients and doctors with the safest and most effective medical technologies. Advanced medical technologies have enriched the lives of millions of patients worldwide, and our industry takes enormous precautions to protect those patients. Although they are rare, unanticipated problems with medical technologies can, and will, occur.

When companies hear of problems from doctors, hospitals or directly from patients, a step-by-step system is in place to address the issue as quickly and effectively as humanly possible. Upholding patient safety and improving patient lives always comes first.

Q: How do companies respond if there are problems?

Advanced medical technologies have enriched the lives of millions of patients worldwide, and our industry takes enormous precautions to protect those patients. When problems do occur, companies work quickly and closely with regulators to determine the best course of action.

Reported problems — and the appropriate response — can vary widely depending on factors like the type of product and the potential health risk posed. In most cases, the problems affect a very small percentage of devices; only rarely do they pose a serious risk to public health.

Sometimes a product must be returned to the manufacturer to be repaired, other times it can be corrected in the field. In other cases, devices can be recalled before they ever reach patients.

Q: Who makes the decision to recall a medical technology?

Our industry takes a pro-active approach to safety, which is why 99 percent of recalls are voluntary and initiated by the company. If it is determined that a medical technology may pose a risk to public health, either the manufacturer or the FDA can have the product removed from the market.

Q: Do you take all recalls seriously?

Yes. However, of the millions of patients worldwide who benefit from advanced medical technologies each year, a very small percentage of these will ever face a health risk as a result of a product recall.

FDA has classified a range of actions as recalls — from simple labeling changes to production corrections. These recalls are risk-based and classified into one of three categories:

• Class I recalls are situations that may pose a serious health risk to patients. In these situations, medical technology manufacturers have 24 hours to issue a press release (usually written by the FDA) and alert the public. Of the millions of medical technologies being used by patients and doctors, only a small handful of Class I recalls occur each year.

• Class II recalls are situations where adverse health consequences are temporary or medically reversible or that pose a remote chance of adverse consequences.

• Class III recalls are not likely to pose any health risk.

Our industry takes a pro-active approach to safety, which is why 99 percent of recalls are voluntary and initiated by the company.

If it is decided that a recall is necessary, FDA regulations outline detailed step-by-step procedures for manufacturers to follow in conducting timely, complete recalls. These procedures include: performing an evaluation to determine the health risk posed by the product; developing a strategy to complete the recall; and periodically submitting recall status reports to the agency.

Manufacturers are required by law to report to FDA when they initiate a recall for a problem that poses a risk to patients' health (Class I and Class II). Many companies go beyond this requirement and voluntarily report the least serious (Class III) recalls as well.

Q: How do you communicate serious health risks to patients?

Effectively communicating health risks to patients is critical to ensuring patient safety. Our industry takes enormous precautions to protect patients, but when problems occur, medical technology companies work closely with regulators to determine the best way to alert the public and health care professionals in cases of serious adverse events.

Typically only a small number of patients would be affected by a recall, so notifications usually extend to the level of the physician, who serves as the critical link between the manufacturer and patient and prevents needless confusion and anxiety. The physician is in the best position to determine if an individual patient could be affected by a recall.

Q: Do manufacturers keep track of all devices on the market?

Millions of patients worldwide have benefited from advanced medical technologies, and our industry takes enormous precautions to protect those patients. It would not be practical or particularly effective to track every one of the millions of patients and millions of devices now on the market.

Patients move, change doctors, and switch insurance carriers frequently, making it nearly impossible to follow every patient and every technology. In addition, contacting patients directly limits the physician's role in evaluating if a patient is at risk.

Tracking technologies such as heart valves, implantable pacemakers and defibrillators, heart assist devices and continuous ventilators that could pose a serious health risk may be required by regulators, but it does not make sense to track every single medical technology on the market.

Q: What happens to AdvaMed member companies when they make faulty products?

Our industry is dedicated to advancing medical technology to improve patient care and helping people live longer, healthier, more productive lives. Medical technologies must be safe to be effective. If there are any problems with a company's technology, they will face the scrutiny of patients, doctors and all regulatory and legal authorities.

-July 2005