FDA provides rigorous oversight of medical devices

Published: 06/25/2009

WASHINGTON, D.C., USA - (HealthTech Wire / News) - Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement regarding today’s hearing of the House Energy & Commerce Health Subcommittee on medical device regulation:

“AdvaMed urges Members of Congress to carefully consider how American patients benefit from FDA’s risk-based, science-driven method for determining the safety and effectiveness of medical devices – a system that has served the public effectively for over 30 years.

“FDA has comprehensive authority to regulate medical devices through a combination of premarket and postmarket controls. Each year, FDA subjects thousands of medical devices to extensive review to determine whether they are safe and effective before they are allowed on the market. Recognizing the diversity of medical technologies, FDA requirements are calibrated so that the level of regulation is appropriate to the individual device.

“Breakthrough technologies require premarket approval applications (PMAs) that are backed by exhaustive clinical and preclinical data that takes years and millions of dollars to gather. For lower-risk products, the agency’s 510(k) process provides a stringent regulatory framework for the review of incremental improvements and changes for devices already on the market and whose risks are well-understood. It involves extensive FDA review of specifications and performance testing information, and, if the agency deems necessary, clinical data, before FDA determines whether a device can be made available for patients.

“Once a medical technology is allowed to go to market, companies must follow strict manufacturing controls to ensure that the devices continue to be safe and effective. These controls are structured so that quality is built into a medical technology at every phase of a device’s life – from design to pre-production to full-scale production to market commercialization.

“In addition, medical technology firms are required to establish extensive systems to monitor the performance of their products in the marketplace and are required to report to FDA any device-related death, serious injury, or malfunction.

“It is important to remember that millions of Americans benefit from advanced medical technologies each year, and FDA’s regulatory system should continue to ensure that American patients have timely access to life-sustaining and life-enhancing innovations.”