Premarket Notification (510(k))

The Premarket Notification (510(k)) is the primary regulatory pathway used by the U.S. Food and Drug Administration (FDA) to market most Class I and Class II medical devices. Unlike the Premarket Approval (PMA) process, which requires proof of safety and effectiveness, the 510(k) pathway focuses on demonstrating equivalence to an existing, legally marketed device.

In simple terms, a Premarket Notification (510(k)) is a submission required to be sent to the FDA at least 90 days before a person intends to introduce a device into commercial distribution. Its purpose is to demonstrate that the new device is Substantially Equivalent (SE) to a device already legally marketed in the U.S. that does not require PMA.

The number assigned by FDA to a premarket device submission like a 510(k) is known as the FDA premarket submission number.

The 510(k) process is crucial for device manufacturers seeking FDA clearance for Class I and Class II devices.

When a Premarket Notification (510(k)) is Required

A premarket notification submission is required from each person who is required to register their establishment. This submission must occur at least 90 days before the device is introduced into commercial distribution.

A 510(k) is required if the device meets any of the following criteria:

• First-Time Introduction: The device is being introduced into commercial distribution for the first time by a person required to register.
• "New" Device Classification: The device is being introduced into commercial distribution for the first time and is not of the same type as, or substantially equivalent to, a device in commercial distribution before May 28, 1976, or one subsequently reclassified into Class I or II.
• Significant Change or Modification: The device is currently distributed or is being reintroduced, but is about to be significantly changed or modified in design, components, method of manufacture, or intended use.

Significant Changes Requiring a 510(k) include:

A change or modification that could significantly affect the safety or effectiveness of the device (e.g., a significant change in design, material, chemical composition, energy source, or manufacturing process) [61(i)].

A major change or modification in the intended use of the device [62(ii)].

If a manufacturer determines that a change to an exempted generic type of Class I or II device affects its intended use or fundamental scientific technology, a 510(k) submission is still required.

The Core Principle: Substantial Equivalence (SE)

FDA determines that a device is substantially equivalent to a predicate device using specific criteria:

Same Intended Use: The device must have the same intended use as the predicate device [91(1)].

Technological Characteristics: The device must either have the same technological characteristics as the predicate device [91(2)(i)], OR [91(2)(ii)]:

• Have different technological characteristics (e.g., a significant change in materials, design, energy source, or other features) [92(A)].
• The submitted data establishes that the device is substantially equivalent, demonstrating that the device is as safe and as effective as a legally marketed device [92(B)]. This data may include clinical data if deemed necessary by the Commissioner [92(B)].
• The device does not raise different questions of safety and effectiveness than the predicate device [92(C)].

The PMA/510(k) Number is one piece of information that manufacturers must submit in their individual adverse event reports to the FDA [26(5)].

Submission Content Requirements

A 510(k) submission is required to include the following information:

Device Identification: The device name, including the trade or proprietary name and the common or usual name or classification name [65(a)].

Regulatory Information: The establishment registration number (if applicable) [65(b)], and the class into which the device has been placed [65(c)].

Labeling and Advertising: Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and directions for its use. Where applicable, photographs or engineering drawings must be supplied [66(e)].

Comparison Data: A statement indicating the device's similarities to and/or differences from other comparable products in commercial distribution, supported by data [66(f)]. This information may include identification of similar products, materials, design considerations, energy expected to be used, and a description of the operational principles [66(f)].

Safety and Effectiveness Consideration: If the device has undergone a significant change or modification that could significantly affect safety or effectiveness, the submission must include appropriate supporting data to show the manufacturer has considered the consequences of the change on safety and effectiveness.

Summaries/Statements: Either a 510(k) summary (summary of safety and effectiveness information that supports the substantial equivalence determination) [41, 68(h), 73(a)] or a 510(k) statement (asserting availability of safety and effectiveness information upon request) [42, 68(h), 79(a)(1)].

Certification: A financial certification or disclosure statement as required by Part 54 [68(i)].

Clinical Data: If supported by clinical data from investigations conducted in the U.S., a statement of compliance with human subjects and IRB regulations (Parts 50, 56, and 812) [68(j)(1)].

FDA Action and Outcome

FDA reviews the premarket notification submission and issues an order determining the regulatory status:

Substantially Equivalent (SE) Order: An order is issued declaring the device to be substantially equivalent to a legally marketed predicate device [90(1)]. Until the applicant receives this order, they may not proceed to market the device [91(5)].

Not Substantially Equivalent (NSE) Order: An order is issued declaring the device to be not substantially equivalent to any legally marketed predicate device [90(2)].

Request for Additional Information: FDA may request additional information [90(3)]. If the information requested is not submitted within 30 days, the premarket notification will be considered withdrawn.

Other Actions: FDA may also withhold the decision until a certification or disclosure statement is submitted [90(4)], or advise the applicant that the premarket notification is not required [91(5)].

Confidentiality

The existence of a 510(k) submission may be disclosed by the FDA once the device is on the market or if the intent to market has been disclosed publicly by the submitter. However, the FDA will not disclose the existence of a submission for a device not yet on the market for 90 days if the submitter specifically requests confidentiality.

FDA will make a 510(k) summary of the safety and effectiveness data available to the public within 30 days of issuing a determination that the device is substantially equivalent to another device.

Analogy for Understanding Premarket Notification (510(k))

The Premarket Notification (510(k)) process is like seeking permission to sell a new model of a standardized product, such as a toaster (Class II device). Instead of having to prove that the toaster is fundamentally safe from scratch (like a PMA), you simply demonstrate that your new toaster works just as safely and effectively as a toaster that has been on the market for years (the predicate device). You show that it has the same components, slices bread the same way (intended use), and uses electricity similarly (technological characteristics). If you add a new feature, like a digital screen (different technological characteristic), you must provide data to prove that the screen doesn't make the toaster significantly less safe or raise new safety questions [92(A), 92(C)]. Once the FDA agrees it's Substantially Equivalent, you receive clearance to sell the product.

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