How do medical devices get approved? INN breaks down the FDA’s intricate process for classifying and regulating these products in the US.
Life science investors are familiar with the arduous path new drugs must go through to reach the market. But what about medical devices? How do medical devices get approved?
In terms of devices, the same rigorous testing and inspection are required from different regulatory agencies. The US Food and Drug Administration (FDA) is the agency tasked with reviewing new devices and making amendments to already approved devices. More specifically, medical device approval is done through the FDA’s Center for Devices and Radiological Health (CDRH). The CDRH looks after the entire regulation process for companies that manufacture, repackage, relabel and import devices to the US.
Below, the Investing News Network examines FDA approval and how the FDA classifies and regulates medical devices. This process determines how everything from pacemakers to dental floss get on American shelves. It’s critical for those interested in medical devices to understand this system, as sending a product to market is key for company profits and investor returns.
Classifying medical devices
The FDA divides medical devices into three categories based on their perceived potential to do harm. Class I medical devices are designated as low risk. These are products that don’t seem all that dangerous and generally are well established, such as enema kits, elastic bandages and manual stethoscopes. At 47 percent, nearly half of all medical devices are considered Class I.
As such, Class I medical devices are subject to the least restrictive regulatory requirements. Most, for example, do not require a Premarket Notification 510(k) — that is, a manufacturer does not need to prove that its device is “substantially equivalent” to one already on the market.
When it comes to Class II medical devices, a Premarket Notification 510(k) is one of the requirements. That’s because these devices are potentially more harmful than Class I products and therefore need to demonstrate safety. This division includes items like handheld surgical instruments and infusion pumps. These types of medical devices make up 43 percent of the market.
Then there are Class III medical devices, or products deemed to have the highest risk. Class III devices only make up 10 percent of all medical devices. Generally speaking, a lot more than a 510(k) is needed to get these devices to market.
Replacement heart valves, denture adhesives, aspirators and breast implants — these products, and others like them, all require Premarket Approval before receiving clearance. That means more comprehensive and thorough clinical trials are required for these devices.
Medical device regulation
The procedures, trials and regulations for Class II and Class III medical device approvals are different.
In filing a Premarket Notification 510(k), manufacturers have to prove that their product is as safe and has the same effectiveness as a “predicate” — in other words, a similar device that’s already been regulated and commercialized.
The predicate and its substantially equivalent product must also have the same intended use. If the latter uses different technology, additional information needs to be submitted to be considered for clearance, showing that no patient safety concerns appear with the new device.
According to the FDA, it takes approximately 90 days to determine substantial equivalency. Only once a product has been cleared can a company bring it to market.
On the other hand, Class III medical devices, as well as those not found to be substantially equivalent in the 510(k) process, must receive a Premarket Approval. In this instance, companies need to submit clinical data for the FDA to evaluate, and it takes time to first acquire those findings.
To collect clinical data, companies need to submit still another application to the FDA. An Investigational Device Exemption allows medical device manufacturers to use their product candidates in clinical trials.
Once the studies have been completed and the Premarket Approval application filed, the review process takes at least 180 days. A decision is then posted publicly on the FDA’s website and anyone can petition the agency to ask it to reconsider its approval or rejection. This public review window lasts 30 days.
Similar to other industries within the healthcare sector, costs are extremely high when it comes to medical device research and development. This means innovation in the space may leave some companies wary, but, as technology continues to evolve and advance, it is becoming increasingly difficult to ignore the impact it will — and already does — have on devices.
Technologies disrupting the space as of right now include smart inhalers, robotic surgery, wireless brain sensors, 3D printing, artificial organs and health wearables.
In short, there is plenty of evidence to show the need for this market is second-to-none thanks to increasing demand from hospitals and surgical centers. However, the FDA has made changes to the medical device approval process, which has slowed down the number of devices approved. While the changes seemed to affect the number of devices approved in 2018, when 35 devices were okayed, 2019 saw gains being made and a total of 46 medical devices were approved.
In late 2018, the FDA set forth a proposal to change device regulations so companies would be required to use recently approved devices as predicates; those changes have not yet come into play.
Despite some of the potential roadblocks, according to a Research and Markets medical device market report, the industry will reach US$409.5 billion by 2023, growing at a compound annual growth rate of 4.5 percent from 2018 to 2023. Fueling that growth will be healthcare spending, technology developments, the aging patient population and chronic diseases.
This is an updated version of an article first published by the Investing News Network in 2017.
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Securities Disclosure: I, Nicole Rashotte, hold no direct investment interest in any company mentioned in this article.