Understanding the difference between FDA clearance and FDA approval is essential for patients pursuing medical device lawsuits. Most medical devices reach the market through 510(k) clearance, which requires far less safety testing than full FDA approval—a regulatory gap that has allowed dangerous devices to reach patients without adequate evaluation.
The 510(k) Clearance Pathway
The vast majority of medical devices enter the market through the 510(k) premarket notification process. Under this pathway, manufacturers must only demonstrate that their device is "substantially equivalent" to a device already legally marketed—called a predicate device. This process does not require clinical trials proving the new device is safe and effective.
The fundamental flaw in 510(k) clearance is that devices can be cleared based on equivalence to other devices that were themselves cleared through the same process, creating chains of predicate devices stretching back to products that predate modern safety standards. A device may be "substantially equivalent" to its predicate while still differing in ways that create new risks.
The 510(k) process typically takes only 3-6 months and costs manufacturers far less than full approval, creating strong incentives to use this pathway whenever possible.
The Premarket Approval (PMA) Pathway
Higher-risk devices classified as Class III must go through premarket approval (PMA), which requires manufacturers to submit clinical trial data demonstrating the device is safe and effective for its intended use. This rigorous process typically takes one to three years and costs millions of dollars.
PMA-approved devices have undergone scientific review of clinical data by FDA experts, providing much stronger assurance of safety than 510(k) clearance. However, the PMA process also creates significant legal implications for patients injured by these devices.
Why This Matters for Lawsuits
The pathway a device followed to market directly affects legal claims:
510(k)-cleared devices are generally subject to state law product liability claims. Plaintiffs can argue that FDA clearance merely means the device is similar to an existing product, not that FDA determined it to be safe. Many successful medical device lawsuits have involved 510(k)-cleared products.
PMA-approved devices may be protected by federal preemption under the Supreme Court's decision in Riegel v. Medtronic. This means state law claims alleging design defects or failure-to-warn may be barred because FDA specifically approved the device's design and labeling. Patients injured by PMA devices face significant legal hurdles, though claims based on manufacturing defects or violations of federal requirements may still proceed.
The De Novo Pathway
A third pathway, De Novo classification, exists for novel low-to-moderate risk devices that have no predicate. This pathway requires more review than 510(k) but less than PMA, and devices cleared through De Novo can become predicates for future 510(k) submissions.
Criticisms of the Regulatory System
Medical device regulation has faced substantial criticism:
The 510(k) process allows dangerous devices to reach patients without adequate safety testing. Transvaginal mesh, metal-on-metal hip implants, and various recalled devices all reached the market through 510(k) clearance.
FDA clearance creates false confidence among patients and physicians who may believe "FDA cleared" means "FDA tested and approved." The distinction between clearance and approval is rarely explained during informed consent.
Predicate creep allows devices to be cleared based on equivalence to devices that are themselves obsolete, recalled, or known to have problems.
Implications for Your Case
If you're considering a medical device lawsuit, determining how your device reached the market is essential. An attorney experienced in device litigation can research the regulatory history of your specific device and explain how clearance versus approval affects your legal options.