The U.S. Food and Drug Administration (FDA) rules for medical devices aim to further protect patients from unnecessary risks. At the same time, they ensure quick access to new, safe, and effective medical technologies.
This balance is key to the FDA’s mission to protect and promote public health. It is especially important for medical device manufacturers dealing with a more complex regulatory environment.
Much attorneys can help medical device manufacturers remain compliant with the changing regulatory landscape, allowing them to protect and grow their product lines.
Understanding Pathways for Medical Devices
FDA oversight of medical devices is intentionally risk-based. The amount of premarket review needed to show safety and effectiveness matches the risk level of a device.
Higher-risk devices have stricter rules. Lower-risk devices are reviewed using methods that match their safety records and technology level.
Depending on classification and risk, manufacturers may pursue one of the following regulatory pathways:
- Premarket Approval (PMA): Required for most Class III, high-risk devices
- De Novo Classification Request: Available for novel, low- to moderate-risk devices without a legally marketed predicate
- Premarket Notification (510(k)): Applicable to low- to moderate-risk devices that can demonstrate substantial equivalence to a legally marketed predicate device
Across all pathways, FDA review is grounded in the principles of safety and effectiveness. The lowest-risk devices are subject to general controls and are often exempt from premarket review.
Premarket Approval (PMA)
PMA represents the FDA’s most stringent premarket review pathway and requires an independent demonstration of safety and effectiveness. This pathway is reserved for devices that are life-supporting or life-sustaining, of substantial importance in preventing impairment of human health, or that present a potential unreasonable risk of illness or injury.
Importantly, PMA is not and was never intended to be the default pathway for all medical devices.
Using PMA-level requirements for lower-risk technologies would create extra costs. It would also delay patient access and take FDA resources away from high-risk or new devices.
De Novo Classification Request
The De Novo request is a risk-based FDA marketing pathway for novel medical devices that have no legally marketed predicate. It allows devices to be classified as Class I or Class II when general controls, or general and special controls, are sufficient to ensure safety and effectiveness.
Devices granted De Novo classification may be marketed and can serve as predicates for future 510(k) submissions. The FDA established regulations for this process under section 513(f)(2) of the FD&C Act to provide a clear pathway for certain new device types to obtain marketing authorization.
The 510(k) Clearance Process
The 510(k) clearance pathway is a cornerstone of the U.S. medical device regulatory system. Unlike PMA, which relies on an independent showing of safety and effectiveness, the 510(k) standard is comparative. A manufacturer must demonstrate that its device is substantially equivalent to a legally marketed predicate device with respect to intended use, technological characteristics, and performance.
Substantial equivalence decisions are based on scientific analysis. They may need non-clinical testing, clinical data, and detailed performance information. This depends on the type of device. Although the standard differs from PMA, safety and effectiveness remain central to every 510(k) review.
To promote regulatory predictability, the FDA has issued numerous device-specific guidance documents outlining expectations for testing, labeling, and submission content. For manufacturers, adherence to these guidelines is critical to efficient review and defensible regulatory outcomes.
Increasing Complexity and FDA Expectations
As medical technologies have advanced, the scope and complexity of 510(k) submissions have increased. Since 2009, the average 510(k) submission has increased to over 1,000 pages. More data is needed, and the FDA is paying closer attention. These developments underscore the importance of careful regulatory strategy, thorough documentation, and legal oversight.
Contact Your Much Attorney
For medical device manufacturers, it is critical to understand and effectively navigate the available pathways for medical device clearance, including when and how to use each option.
In many cases, the FDA’s 510(k) clearance pathway is the preferred and most effective option, providing a well-established route to market while managing regulatory risk.
A thorough understanding of the 510(k) process is essential not only for achieving market access but also for responding to FDA scrutiny and defending cleared devices in regulatory reviews or litigation contexts.
At Much, our attorneys work with medical device manufacturers to meet FDA regulations, reduce audit risk, and navigate the pathway to medical device clearance. Contact your Much medical device attorney today.