The three main FDA device pathways—510(k), PMA, and De Novo—are chosen based on device risk, novelty, and predicate availability. Selecting the right route early streamlines approval, ensures compliance, and minimizes delays.
Selecting the correct regulatory pathway is essential to bringing a device to market efficiently. The three principal routes—510(k), Premarket Approval (PMA) and De Novo—are determined by device risk, novelty and available predicates.
The 510(k) pathway applies to most Class II and some Class I devices. Manufacturers must show that the new device is substantially equivalent to a legally marketed predicate. This route generally requires fewer supporting data than PMA, making it less burdensome. The FDA’s performance goal is to complete a 510(k) review in 90 FDA days, and user fees are moderate ($24,335 standard; $6,084 for small businesses). Special and abbreviated 510(k) pathways may reduce documentation requirements for certain modifications or when recognized standards are used.
PMA is reserved for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health or present potential unreasonable risk. PMAs require extensive evidence, often including clinical studies, to demonstrate safety and effectiveness. The application process includes device description, design controls, manufacturing methods, preclinical studies and clinical data. The review timeline is longer (approximately 180 days), and user fees are substantially higher. PMA supplements are required for significant changes post‑approval.
When there is no predicate for a novel device of low to moderate risk, the De Novo pathway is available. Manufacturers may submit a De Novo request after receiving a Not Substantially Equivalent determination or directly if they believe no predicate exists. If granted, the device is classified into Class I or II with appropriate special controls, and the De Novo device can then serve as a predicate for future 510(k)s. This pathway balances innovation with safety by establishing a new device type and controls tailored to the device’s risks.
Consider the following factors:
Engaging the FDA through a pre‑submission can clarify which pathway is appropriate and highlight any data gaps. Choosing the correct path early prevents delays and aligns your development activities with regulatory requirements.
