Pathways to Device Development and FDA Approval 

If you’re a medtech innovator looking to gain regulatory approval for your device, implant or treatment from the USA Food and Drug Administration (FDA), then it’s vital you know the right pathway for your product.

Some considerations include:

• determining if you need to file a 510(k) or premarket approval (PMA) application, or if your product is exempt;
• understanding if your medical device falls into Class I, II or III (that is, the perceived level of risk of any type of injury to users), which in turn dictates the amount of control enforced by the FDA over approvals, manufacturing and other processes;
• ensuring you have a well-documented quality assurance system, compliant with the FDA’s quality system regulation (QSR); and
• for those not based in the USA, appointing a US-based agent as part of the registration process to act as your representation to the FDA.

Achieving 510k clearance

Most medical devices approved by the FDA are classified as Class II, and receive approval through the 510(k) clearance pathway. The key to this process is showing that a new device has “substantial equivalence” to a predicate – that is, something of the same type that’s already legally marketed. A predicate helps you to justify the new product’s safety.

What makes a new device substantially equivalent to a predicate? Factors include the same intended use and/or tech features; or the same intended use with different tech features but don’t raise new concerns around safety and effectiveness (showing that your device is as safe and effective as the predicate).

Making a De Novo request

Where a device has been found by the FDA to be not substantially equivalent (NSE), the De Novo classification process is a valuable pathway. In this situation, “general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device” (FDA, 2022). The class category under which the device falls will be determined by the FDA, within 120 days of receiving the application. Once a De Novo request is approved, the new device can be immediately marketed – and it then becomes a predicate device for others.

PMA pathways

Products which fall under the Class III category are typically cleared under the PMA pathway – often a one to three-year process – as they are subject to the strictest regulatory controls. Application approval is “based on a determination by the FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).” (FDA, 2019)

Humanitarian device exemption (HDE): Some Class III devices with proposed use for small populations of people with very rare conditions may be granted pre-market approval under the HDE pathway. This pathway requires evidence of the device’s likely health benefit for a specific cohort of patients, outweighing the risk.

Custom devices: A pathway also exists for custom devices that are significantly more novel than those approved via the De Novo process – for example, a device used in the treatment of a rare condition impacting a small subset of the population, and thereby rendering typical clinical trials impractical.

Being fully informed about the appropriate FDA pathway for your medical device helps to protect you from big headaches later on, and ensuring all practices across the lifespan of your medtech device are compliant. Learn more via the FDA website.