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What is Premarket Notification [510(k)]

Each person who wants to market Class I, II and some III devices intended for human use in the U.S. must submit a 510(k) to FDA at least 90 days before marketing unless the device is exempt from 510(k) requirements. There is no 510(k) form but instead a format for the submission described in 21 CFR 807 and in the pages that follow.

A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval(PMA). Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found to be substantially equivalent to such a device through the 510(k) process, or one established through Evaluation of Automatic Class III Definition. The legally marketed device(s) to which equivalence is drawn is known as the "predicate" device(s).

Applicants must submit descriptive data and, when necessary, performance data to establish that their device is SE to a predicate device. Again, the data in a 510(k) is to show comparability, that is, substantial equivalency (SE) of a new device to a predicate device.

What is Substantial Equivalence

Unlike PMA, which requires demonstration of reasonable safety and effectiveness, 510(k) requires demonstration of substantial equivalence. SE means that the new device is as safe and effective as the predicate device(s).

A device is SE if, in comparison to a predicate device it:

  • has the same intended use as the predicate device; and
  • has the same technological characteristics as the predicate device; or
  • has different technological characteristics, that do not raise new questions of safety and effectiveness, and the sponsor demonstrates that the device is as safe and effective as the legally marketed device.

A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. Detailed information on how FDA determines substantial equivalence can be found in the Premarket Notification Review Program 6/30/86 (K86-3) blue book memorandum.

Until the applicant receives an order declaring a device SE, they may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. If FDA determines that a device is not SE, the applicant may resubmit another 510(k) with new data, file a reclassification petition, or submit a premarket approval application (PMA). The SE determination is usually made within 90 days and is made based on the information submitted by the applicant.

Who is Required to Submit a 510(k)

The Food, Drug and Cosmetic (FD&C) Act and 510(k) regulations in 21 CFR 807 do not specify who must apply for a 510(k) - anyone may do so. Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission.

Based on the specified actions, the following four categories of parties must submit a 510(k) to the FDA:

  1. Domestic manufacturers introducing a device to the U.S. market;

    Finished device manufacturers have to submit a 510(k) if they assemble a device according to their own specifications and market it in the U.S. However, manufacturers of device components are not required to submit a 510(k) unless such components are promoted for sale to an end user as replacement parts. Also, contract manufacturers, those firms assembling devices on contract according to someone else's specifications, are not required to submit a 510(k).
  2. Specification developers introducing a device to the U.S. market;

    FDA views specification developers almost the same as manufacturers. These are persons who develop specifications for a finished device, but have it manufactured under contract by another firm or entity. The specification developer submits the 510(k), not the contract manufacturer.
  3. Repackers or relabelers who make labeling changes, or whose operations significantly affect the device.

    Repackagers or relabelers may be required to submit a premarket notification if they significantly change the labeling or otherwise affect any condition of the device. Here you must ascertain if you are significantly changing labeling, by modifying manuals, deleting or adding warnings, contraindications, etc., and if your packaging operation could alter the condition of the device. However, most repackagers or relabelers are not required to submit a 510(k).
  4. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.

When a 510(k) is Required

A 510(k) is required when:

  1. Introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device Amendments to the FD&C Act), anyone who wants to sell a device in the U.S. has been required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. If your device was not marketed by your firm before May 28, 1976 a 510(k) is required. Refer to the guidance entitled Deciding When to Submit a 510(k) for a Change to an Existing Device
  2. You propose a different intended use for a device which you already have in commercial distribution. The 510(k) regulation (21 CFR 807) specifically requires a premarket notification submission for major changes in intended use. Intended use is indicated by claims made for a device in labeling or advertising. However, most, if not all changes in intended use will require a 510(k).
  3. There is a change or modification of a device you already market, if that change could significantly affect its safety or effectiveness.

The burden is on you to decide whether or not a modification could significantly affect safety or effectiveness. Whatever your conclusion, make a record which should be reflected in your device master record and change control records, required under the medical device good manufacturing practices. Then, if you're challenged, you will be able to document that in good faith you evaluated the change.

A new, complete 510(k) application is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication.

When a 510(k) is Not Required

The following are 7 examples of when a 510(k) is not required.

  1. If you sell unfinished devices to another firm for further processing, including components to be used in the assembling of devices by other firms. However, if your components are to be sold directly to end users as replacement parts, a 510(k) is required
  2. If your device is not being marketed or commercially distributed. You do not need a 510(k) to develop, evaluate, or test a device. This includes clinical evaluation. It is important to mention that if you do perform clinical trials with your device, you may be subject to the Investigational Device Exemption (IDE) Regulation.
  3. If you distribute other firm's domestically manufactured devices you need not submit a 510(k). You may place a label on the device "Distributed by ABC Firm", and sell it to end users without submission of a 510(k).
  4. In most cases if you are a repackager or a relabeler you are not required to submit a 510(k) if the existing labeling or condition of the device is not significantly changed.
  5. If your device was legally in commercial distribution before May 28, 1976, you do not have to submit a 510(k) unless it has been modified or there has been a change in its intended use. These devices are "grandfathered".
  6. If you are an importer of a foreign made medical device, a 510(k) is not required if:
    1. 510(k) has been submitted by the foreign manufacturer and received marketing clearance, or
    2. 510(k) has been submitted by an importer on behalf of the foreign manufacturer and has received marketing clearance. If one importer submits a 510(k) on behalf of the foreign manufacturer, all other importers of that device, imported from the same foreign manufacturer (the 510(k) Holder) are not required to submit a 510(k) for that device.
  7. If your device is exempted from this requirement by final classification regulation subject to the limitations on exemptions. That means certain Class I or II devices can be marketed for the first time without having to submit a 510(k). A compilation of the Class I and II exempted devices can be found in the MEDICAL DEVICE EXEMPTIONS page.

For more information go Deciding When to Submit a 510(k) for a Change to an Existing Device page especially for numbers 3 and 4.

The Modernization Act and the 510(k) Submission Process - Different Types of Submissions for Differing Situations

To streamline the evaluation of premarket notifications for the reserved Class I devices, Class II devices subject to premarket notification, and preamendments Class III devices for which FDA has not yet called for PMAs, the Agency has developed The New 510(k) Paradigm which in certain instances presents device manufacturers with two new optional approaches for obtaining marketing clearance for devices subject to 510(k) requirements. The document contains the following reference chart for use in determining which type of 510(k) is suitable for a given set of circumstances.

 

 

Reference: www.FDA.gov

 

The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation.