Questions Remain After FDA Offers New Designation To Medical Device Manufacturers

Questions Remain After FDA Offers New Designation To Medical Device Manufacturers

April 18th, 2022 // 1:07 pm @

In 2017, FDA launched a new regulatory program to speed up the development of medical devices. It’s estimated the program has helped a minimum of 45 medical devices come to market.

It is believed more than 650 medical devices have what is known as ‘breakthrough designation’, which means FDA thinks the device could be more effective to treat or deal with serious medical conditions.

FDA has not disclosed how and why a medical device earns this breakthrough designation. FDA regulatory experts say this information is important to help medical professionals make decisions about how to care for patients and get reimbursements for new scientific breakthroughs and technology.

Medical device companies that get this breakthrough status still need to go through several regulatory hoops if they want to get their product to market. However, FDA gives them help to get through the process. This includes the ability to talk often to various FDA officials. They also are offered more flexibility about how they make clinical trials, and they get a speedier FDA review when they request FDA authorization.

The idea of the special medical device program is to offer a higher level of engagement between the agency and device manufacturers. The goal is to help companies device significant medical devices faster and evaluate the products that may make a huge difference when there is no other option for patients, according to officials at CDRH.

But many of these conversations transpire between FDA and companies behind closed doors, and because the agency doesn’t publicize information on this process, device experts note it may be hard to know the risks and benefits of significant medical devices.

It’s desirable to want more access to important medical devices for patient care, but the agency also must make sure the devices are evaluated fully. That way, the agency knows patients are getting access to new technology that makes them better.

To receive FDA authorization, the medical device maker must show the agency that they are safe and effective. For a higher risk device such as one for the heart, studies are usually needed that follow hundreds of patients over months or years.

But for a breakthrough medical device, there is a big difference: New technology is greatly needed by patients, so the agency may accept a higher degree of risk and uncertainty about those results. In return, the medical device company will commit to do more research on the device after they receive FDA authorization.

However, those clinical studies may not be close to done when the product goes to market, so the patient and provider could make decisions about whether the device should be used but they don’t have all the safety and effectiveness data.

Many question if there are significant benefits to these devices, if they work and if they improve patients’ lives. Health policy experts want a higher degree of transparency into how the FDA breakthrough program is run. This would inform patient decisions better and allow for more effective FDA regulations.

Only limited data is available about breakthrough medical devices, but some FDA experts are concerned that providers and patients could assume device companies have shown the devices are better and more effective than the other options.

Answers on these critical questions may take a long time. It could take years to know if a breakthrough medical device is more effective than traditional treatments. FDA only can mandate clinical studies that compare products directly if the breakthrough will market itself as a better option.

It would be best if we could understand the comparative benefit for the breakthrough device compared to the current standard of care. It’s just too early to say if we are receiving innovation that will help patients with serious medical conditions.

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