Learn about the FDA regulatory pathways for bringing a medical device to market, including 510(k), De Novo, and PMA processes essential for compliance and approval.
If you work with medical devices in the U.S., you have probably heard of the 510(k) process. Those developing high-risk devices may also know the PMA and De Novo pathways. These three are the most commonly used, but seven major routes exist for bringing a device to market.
Many companies assume 510(k) is best simply because it is popular, yet another pathway might suit your product and strategy better.
Rather than viewing regulation as a set of hoops, build a regulatory plan that fits your device and differentiates you from competitors.
The seven major U.S. pathways are:
Developing a one-of-a-kind device for a specific patient? It may qualify under the Custom Device Exemption (CDE).
The device should address a unique pathology or physiological condition for which no comparable domestic alternative exists. It must be assembled or finished case-by-case to meet the patient’s special needs and be created or modified in response to an individual physician’s or dentist’s written order, usually a prescription. The clinician must also use it within his or her normal practice.
FDA limits production to no more than five units per year of a particular device type.
CDE devices skip PMA or 510(k) review, but companies must still follow:
The Expanded Access program—sometimes called compassionate or emergency use—allows an investigational device to reach a seriously ill patient who has few or no alternatives outside of a clinical trial.
Ethical issues must be weighed, yet the approach can supply early feasibility data for high-risk devices, especially when suitable animal models are lacking. These data may later support label expansion, similar to the HDE route.
Expanded access may fit when all of the following apply:
Further reading:
The Product Development Protocol (PDP) is a subset of the PMA process that offers an alternative pathway when device technology is well established.
Companies and FDA reach early agreement on how safety and effectiveness will be demonstrated, creating a plan that details design activities, expected outputs, and acceptance criteria. The firm executes the plan at its own pace, reports agreed milestones, and, on completion, is considered to have an approved PMA.
The Premarket Notification 510(k) pathway is the most common route for medical devices; nearly all Class II and some Class I devices require it.
A 510(k) must show that the new device is substantially equivalent to a legally marketed predicate device with the same intended use and technological characteristics. Sponsors summarize design controls, features, and verification testing in the submission.
FDA review usually takes 30–90 days; incomplete submissions can lengthen the timeline, so thorough documentation at the outset is advisable.
Class III devices, and those unable to demonstrate substantial equivalence through 510(k), must follow the Premarket Approval (PMA) pathway.
PMA requires robust scientific evidence—often from clinical trials—to establish safety and effectiveness. FDA has 180 days to approve or deny the application; the review includes several interactive steps with the sponsor.
FDA device regulation overview
If you are developing a lower-risk “novel” device and cannot identify a predicate, the De Novo pathway may suit you.
Available since 1997, De Novo remains little known because it is rarely used. Companies unable to demonstrate substantial equivalence for a 510(k) should consider this route.
Because no predicate comparison is required, sponsors craft labeling on a “blank canvas” and may set a standard that could offer competitive advantage. A robust risk-mitigation strategy must show the device presents low-to-moderate risk.
The Humanitarian Device Exemption (HDE) pathway supports devices intended for rare diseases or conditions.
The process has two steps: FDA grants Humanitarian Use Device (HUD) designation, then the company submits an HDE application to the appropriate review center.
No comparable device with the same intended use may exist. FDA assesses:
Because rare conditions often lack large clinical datasets, the HDE pathway allows FDA to review safety and probable benefit without full efficacy data.
