Medical Device Oversight and the FDA's Mission
The FDA's regulatory framework for medical device oversight ensures that patients are protected as best as possible from risks, while also allowing patients to benefit from timely access to safe and effective medical devices, consistent with the FDA's mission to both protect and promote public health.
This regulatory framework, which includes the 510(k) clearance process, was set up by Congress initially through the Medical Device Amendments of 1976, which were incorporated into the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Regulatory Pathways for Evaluating Medical Devices
The FDA's oversight of devices is risk-based, which means that the level of regulatory controls necessary to demonstrate a reasonable assurance of safety and effectiveness is typically matched to the level of risk of the device. Devices that pose the highest risks to patients have the most rigorous requirements to demonstrate safety and effectiveness before they can be legally marketed in the United States. Generally, medical devices that are high or moderate risk are subject to review under one of these regulatory pathways based on the device's classification and the degree of risk they present:
- A Premarket Approval (PMA), when the device is high risk, as discussed below in Premarket Approval (PMA) for High-Risk Medical Devices
- A De Novo Classification Request, when the device is low to moderate risk and there is no legally marketed predicate device
- A Premarket Notification [510(k)], when the device is low to moderate risk and there is a legally marketed predicate device
Regardless of the type of regulatory pathway – PMA, De Novo, or 510(k) – the principles of safety and effectiveness underlie the FDA's review of all medical devices. The lowest risk devices are subject to general controls (like other devices reviewed through the above regulatory pathways), but are generally exempt from premarket review.
Premarket Approval (PMA) for Medical Devices
PMA is the most rigorous type of device marketing submission, where the review standard relies on an independent demonstration of safety and effectiveness of the device. PMA is appropriate for high risk devices where general and special controls are not sufficient to provide reasonable assurance of safety and effectiveness of the device and the device is life-supporting or life-sustaining, is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury. For details, see the Regulatory Controls page.
However, the PMA pathway is not used for all medical devices. Certain, lower risk devices similar to other devices on the market may be eligible for the 510(k) pathway or De Novo classification, which provide appropriate patient safeguards for the level of risk of the device. Subjecting devices to higher regulatory oversight than deemed necessary could result in unnecessary costs and delays in getting patients access to the devices they need, while diverting the FDA's staff and resources away from evaluating high risk or novel devices.
The FDA carefully balances the need to provide patients with rapid access to medical devices while providing reasonable assurance of safety and effectiveness for those medical devices through the FDA's review. The agency applies a least burdensome approach to the premarket review process of devices based on the device's classification and degree of risk that the device presents, relying on a comprehensive review of robust safety and performance data and the total product life cycle approach.
The 510(k) Clearance Process for Medical Devices
As further described in the FDA guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], the 510(k) review standard is comparative, whereas the PMA standard relies on an independent demonstration of safety and effectiveness. Nonetheless, the principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review. The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device). Because there are many types of devices, the content in 510(k) submissions can vary greatly.
The FDA has taken many steps (see 510(k) Program Evaluations and Reports page) to explain and clarify the FDA's expectations for a specific device type, including 510(k) submission content, as well as the decision-making process used to determine substantial equivalence. Device-specific guidances, for example, help explain the labeling, testing, and content the FDA expects to see in 510(k) submissions for specific device types. Providing clear expectations to submitters on the appropriate information to include in a 510(k) submission helps expedite the review process, which leads to patients' timely access to safe and effective medical devices in the United States.
As a result of the various actions taken by the FDA's Center for Devices and Radiological Health (CDRH), including the development of policies to clarify and strengthen 510(k) submission content expectations, the average page count of a 510(k) submission has more than doubled, to over 1,000 pages, since 2009. The information provided in a 510(k) submission is necessary for the FDA to determine substantial equivalence and to assure the safety and effectiveness of medical devices.
As medical devices become more complex and innovative, the FDA continues to strengthen and modernize the 510(k) Program. The FDA is taking steps to provide clarity on the FDA's expectations and aims to advance beneficial medical devices to patients, while solidifying the FDA's commitment to safety. Because of the FDA's efforts to continue to modernize the 510(k) Program while technology continues to advance, patients have timely access to high-quality, safe, and effective medical devices.
When a Device Is No Longer Eligible for Review through the 510(k) Process
The FDA may determine that a device should no longer be eligible for review through the 510(k) clearance process as new information on the safety and effectiveness of the device is learned. In these cases, the FDA can — and has — reclassified devices as high risk (class III) and required manufacturers to submit a PMA.
In the past few years, the FDA has been more active in using its authority to reclassify a device type and eliminate the use of such 510(k) cleared devices as predicates when the device type raises safety concerns. Since Congress enacted the Medical Device Amendments in 1976, the FDA has eliminated the use of 1,758 devices as predicates in the 510(k) process. Of these, 84% (or 1,477 devices) were eliminated since 2012 (see 510(k) Program Evaluations and Reports page). The FDA keeps an updated list of devices that have been reclassified since 2013 on the Reclassification page.
Does this mean that recent devices cleared through the 510(k) process are less safe? On the contrary, most device types that are subject to the 510(k) process are technologies that have been used for a long time without safety concerns.
In short, if the FDA believes there is insufficient evidence and controls to reasonably assure the safety and effectiveness of a device type as class II, the FDA will reclassify those devices into class III and require a PMA submission.
Few Recalls Associated with 510(k) Devices
Even though 510(k) cleared devices have become more complex given scientific and technological advances, the FDA has not seen an increase in risks from these devices. In fact, less than 2% of 510(k) devices are subject to any type of a class I or class II recall annually. The number of recalls for 510(k) devices has remained low for more than a decade.
For medical device recalls, the FDA reviews the strategy the company proposes to address the problem, assesses the health hazard presented by the device, and, as appropriate, assigns the recall a classification based on the degree of risk.
The FDA continues to monitor the recall to ensure the recall strategy is effective, and that the device no longer presents a health hazard. See the Medical Device Recalls page for details.
The FDA upholds the principles of safety and effectiveness throughout the total product life cycle of a medical device – from the device's premarket review to assure the safety of devices entering the market, to the continued surveillance of medical devices to monitor for adverse events and recalls.