Overview of Premarket Notification 510(k) - Frequently Asked Q&A

What is a 510k?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (i.e., preamendment or grandfathered device, device reclassified from Class III to II or I, device cleared via 510k, a device cleared via De Novo classification process). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.

Who needs to submit a 510k? Each person/stakeholder who wants to market in the U.S. a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) or De Novo request is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

Note: The term ‘510k exempt’ implies to most of the class I and some class II devices (Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892.) However, there are other types of premarket submissions for class II (De Novo classification process) and class III devices (PMA application).

When is a 510K required?

A 510(k) is required when:

  1. Unless exempt (i.e., most of the class I and few class II devices are 510k exempt), a 510(k) is required whenever introducing a medical device (mostly class II) into commercial distribution (marketing) for the first time.
  2. A new 510(k) submission is required for changes or modifications to an existing device (it can be 510k cleared device or 510k exempt 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 intended use. See Is a new 510(k) required for a modification to the device? for additional information.

When is a 510K not required?

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

  1. You sell unfinished devices to another firm for further processing or sell 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. 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. Please note, however, that if you perform clinical trials with your device, you are subject to the Investigational Device Exemption (IDE) regulation (21 CFR 812).
  3. You distribute another firm's domestically manufactured device that is 510(k) cleared. You may place a label on the device, "Distributed by ABC Firm" or "Manufactured for ABC Firm," (21 CFR 801.1) and sell it to end users without submission of a 510(k).
  4. In most cases, if you are a repackager or a relabeler and the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications.
  5. Your device was legally in commercial distribution before May 28, 1976 and has not been significantly changed or modified in design, components, method of manufacture, or intended use. These devices are "grandfathered" and you have Preamendment Status documentation to prove this.
  6. The device is made outside the U.S. and you are an importer of the foreign made medical device. A 510(k) is not required if a 510(k) has been submitted by the foreign manufacturer and received marketing clearance. Once the foreign manufacturer has received 510(k) clearance for the device, the foreign manufacturer may export his device to any U.S. importer.
  7. Your device is exempted from 510(k) by regulation (21 CFR 862-892). That is, certain Class I or II devices can be marketed for the first time without having to submit a 510(k). However, if the device exceeds the limitations of exemptions as covered under 21 CFR xxx.9, where xxx refers to Parts 862-892 (e.g., 21 CFR 862.9, 21 CFR 864.9), such as the device has a different intended use or operates using a different fundamental scientific technology than a legally marketed device in that generic type of device, or the device is a reprocessed single-use device, then a 510(k) must be submitted to market the new device.

Is there an FDA decision making flowchart?

Yes, this is the FDA decision flowchart below. Please refer to the FDA guidance for complete understanding of this flowchart “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]”

Can foreign companies submit a Premarket Notification 510(k)?

Yes. The foreign manufacturer may submit a 510(k) directly to FDA. For convenience, a foreign manufacturer may receive assistance from a U.S. entity and may use a contact person residing in the U.S. RQMIS provides this service.

Any foreign establishment engaging in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must designate a US Agent for that establishment upon FDA registration. The US Agent must either reside in the US, or maintain a place of business in the US and be available to answer the phone during normal business hours. The US Agent cannot use a PO box or answering service. RQMIS can act as a US Agent on behalf of your company.

Do I need to provide documentation that my facility complies with the Quality System in my 510(k)?

No. However, if you are submitting a Special 510(k), you must provide a declaration of conformity with the design controls aspect of the Quality System. In addition, the FDA may ask, and often do, for manufacturing information for unique processes (e.g., 3D Printing) or provide assurance that the manufacturing process assures the finished device meets material specifications and adequate cleanliness.

Do I need to have my facility inspected to the Quality System regulations before I submit a 510(k)?

No. There is no pre-approval inspection as a prerequisite to 510(k) clearance. However, you should be prepared for an FDA inspection at any time.

How long will it take FDA to review my submission?

FDA has a goal to review and render a decision on all submissions within 90 calendar days, pausing that review clock if they send a Refuse-to-Accept (RTA) letter or an Additional Information (AI) request letter. Within the first 7 days, FDA will acknowledge your submission and begin their acceptance review. The acceptance review should be complete by day 15, at which point FDA will begin their substantive review. FDA may send an RTA or AI letter during their reviews. Both of these responses basically mean FDA needs more information to complete their review. If at any point, you receive a Refuse-to-Accept or Additional Information request letter, you must respond to these letters within 180 calendar days. If FDA has not completed its review within 100 days, they will send a Missed Decision letter explaining the situation and their anticipated timeline.

If FDA clears my medical device, what happens next?

Upon successful review of your 510(k) application, FDA will send you a signed Substantially Equivalent (SE) letter via email announcing a successful review. You’ll also receive a copy of your accepted Indications for Use (IFU) and a unique 510(k) number. FDA will then add your device to the 510(k) database.

You will have to keep your device listed with FDA, and your company will have to maintain its registration with FDA by remaining current with the annual establishment registration fee.

If FDA does not clear my medical device via 510k, what happens next?

If FDA determines that a device is not substantially equivalent, the applicant may:

Are there any Medical Device Exemptions 510(k)?

When a 510(k) submission is required, it means that the FDA is requesting notification, along with evidence that the medical device intended to be marketed is as safe and effective as a previously accepted device, prior to a company commercializing its product. In some instances, though, the FDA has placed specific medical devices into an "exempt" status. Technically, most Class I and some Class II devices are exempt from 510(k) requirements, subject to certain limitations. If you need more information, a listing of Class I and Class II devices exempt from 510(k) requirements is available on the Medical Device Exemptions 510(k) and GMP Requirements website. And you can also contact us, click here.

Now, this is not to imply that the FDA does not have requirements for Class I/II 510(k)-exempt devices. The FDA in fact specifies that companies manufacturing 510(k)-exempt devices still follow certain regulations such as: Registration and Listing, Corrections and Removals, Labeling, and GMPs (good manufacturing practices).

In our next blog you can find the information regarding the 510k Medical device exemptions.

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