How the U.S. FDA Approves Medical Devices

According to Richard R. Orlandi, MD, professor in the division of otolaryngology–head and neck surgery at the University of Utah School of Medicine in Salt Lake City, otolaryngologists must understand that FDA approval does not provide evidence of efficacy for most medical devices. “The FDA deals with safety, but the approval process does not usually address efficacy,” he said. “In an ideal world, we would have efficacy proven when a device hits the market, and there would be solid high level evidence. But, by and large, because of the financial realties of bringing the device to market, that is usually not the case.”

For class 3 devices, which comprise approximately less than 10% of devices, clinical efficacy is required. To gain approval in this class, devices follow a pathway for premarket approval (PMA) that requires evidence of clinical efficacy and safety before approval.

Once most devices are registered on the FDA website, manufacturers are required to comply with the FDA Quality System Regulation (also known as Good Manufacturing Practice or GMP). The FDA conducts random inspections for compliance, which can occur at any time after the device is registered online and includes inspection of suppliers.

Adoption of a Newly Approved Medical Device

Given the lack of efficacy data on most newly approved medical devices, one main challenge for otolaryngologists is how to determine when and if to use a new device.

Physicians are ethically bound to do what is best for the patient, said Dr. Orlandi, so the desire to help the patient using a new technology has to be balanced with the knowledge that the evidence on efficacy (and cost) are not fully known. “That is the challenge, and therein lies the difficulty for physicians to decide when to employ a new particular device in a particular clinical setting,” he said.

The advice he gives physicians is to find out as much as possible about the science behind a new technology and to see if the basic principles behind the purported benefits of the technology make sense. Often, he said, the only evidence available is provided by the company developing the device, and physicians should take that with a “grain of salt.” Dr. Orlandi also emphasized the need for clinicians who help develop and promote new technologies to be upfront and disclose any potential conflicts of interests, to help physicians assess and interpret the evidence.

Because cost is a major factor affecting the feasibility of implementing a new technology in the clinical setting, Dr. Orlandi emphasized the need to look at this factor within the context of the entire value of a technology to a patient. “Sometimes we get wound up about cost, but cost is only one part of the equation,” he said. “It is the change in the outcome of the patient over cost that really determines what the value is for the patient.”