In the United States, the Food and Drug Administration (FDA) approves and clears medical devices before they can be sold. Specifically, the FDA’s Center for Devices and Radiological Health (CDRH) regulates firms that manufacture, repackage, relabel, or import medical devices. Not every device goes through the same process, though. The FDA uses a risk-based system with different pathways depending on how dangerous a device could be if it fails.
How the FDA Classifies Devices by Risk
Every medical device sold in the U.S. falls into one of three classes. Class I covers the lowest-risk products, things like tongue depressors, elastic bandages, and manual stethoscopes. Class II includes moderate-risk devices such as powered wheelchairs, pregnancy tests, and some surgical instruments. Class III is reserved for the highest-risk devices: heart valves, implantable pacemakers, and similar products where a failure could be life-threatening.
All three classes must meet a baseline set of requirements known as general controls, which include proper labeling, manufacturing standards, and registration with the FDA. Class II devices must also meet special controls, which can include specific performance testing or design standards. Class III devices face the most demanding scrutiny: they require premarket approval, meaning the manufacturer must submit clinical trial data proving the device is safe and effective before it can reach patients.
The 510(k) Clearance Pathway
Most moderate-risk devices reach the market through a process called 510(k) premarket notification. This is technically a “clearance” rather than an “approval,” and the distinction matters. Instead of proving a device works from scratch, the manufacturer demonstrates that it is “substantially equivalent” to a device already legally sold in the U.S., called a predicate device.
To qualify as substantially equivalent, a new device must have the same intended use as the predicate. It must also share the same technological characteristics, or if the technology differs, the manufacturer must show those differences don’t raise new safety or effectiveness concerns. The FDA reviews the submission and issues a clearance decision. For fiscal year 2026, the standard application fee for a 510(k) is $26,067, though small businesses certified by CDRH pay a reduced fee of $6,517.
Premarket Approval for High-Risk Devices
Class III devices go through premarket approval, or PMA, which is the most rigorous pathway. A PMA application must include results from nonclinical laboratory studies covering areas like biocompatibility, toxicology, stress testing, and shelf life. It must also include full clinical trial data: study protocols, how patients were selected, demographics, safety and effectiveness results, adverse reactions, and statistical analyses.
This process can take years of development and testing before a manufacturer even submits the application. The standard PMA fee for fiscal year 2026 is $579,272, with a small business rate of $144,818. The cost and complexity reflect the stakes involved. These are devices being implanted in or directly sustaining human bodies.
The De Novo Pathway for Novel Devices
Sometimes a new device doesn’t fit neatly into either pathway. It poses low or moderate risk, making a full PMA unnecessary, but no similar device exists on the market to serve as a predicate for 510(k) clearance. For these situations, the FDA offers the De Novo classification request.
A manufacturer can submit a De Novo request in two ways. The first is after submitting a 510(k) and receiving a “not substantially equivalent” determination because no predicate exists. The second allows manufacturers to skip the 510(k) step entirely if they already know there’s no predicate device to reference. Through De Novo, the FDA evaluates the device’s risk profile and classifies it into Class I or Class II. Once classified, that device then serves as a predicate for future 510(k) submissions from other manufacturers.
Breakthrough Device Designation
For devices that target life-threatening or irreversibly debilitating conditions, the FDA offers a Breakthrough Devices Program that speeds up the review process. To qualify, a device must meet two criteria: it must provide more effective treatment or diagnosis of a serious condition, and it must also represent a breakthrough technology, have no approved alternatives, offer significant advantages over existing options, or serve patients whose best interest requires faster availability.
Devices with breakthrough designation don’t skip the review process, but they get priority. Manufacturers gain access to sprint discussions with FDA experts, feedback on development plans, and clinical protocol agreements during the design phase. All future regulatory submissions for the device, including the final marketing application, receive prioritized review.
What Happens After a Device Is Approved
FDA oversight doesn’t end when a device reaches the market. Manufacturers are required to report adverse events under the Medical Device Reporting system. If a device may have caused or contributed to a death, serious injury, or a malfunction likely to cause harm if it recurs, the manufacturer must report it to the FDA within 30 calendar days of becoming aware of the event.
For more urgent situations, where an event requires immediate corrective action to prevent substantial harm to public health, the reporting window shrinks to five work days. The FDA can also make a written request for a five-day report on any specific event. These mandatory reporting requirements create an ongoing safety surveillance system that continues for the entire time a device remains on the market.
How Other Countries Handle Device Approval
Outside the U.S., the approval process looks quite different. In the European Union, medical devices are regulated under the EU Medical Device Regulation (EU MDR), but the system is decentralized. Rather than a single agency reviewing every device, the EU relies on independent organizations called Notified Bodies to assess whether devices meet regulatory requirements and can receive a CE mark for sale across EU member states.
The FDA’s centralized model means one agency makes the call for the entire U.S. market. The EU’s Notified Body system distributes that responsibility, which can lead to different timelines. For routine updates and patches to existing devices, the FDA’s centralized guidance generally allows faster deployment. The EU MDR framework tends to require more extensive assessment for changes, particularly for higher-risk devices, where Notified Bodies may need to review any modification that could affect safety, performance, or intended use. Both systems prioritize safety, but they structure their oversight in fundamentally different ways.