In the United States, medical devices are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Center for Devices and Radiological Health (CDRH) is primarily responsible for overseeing the pre- and post-market aspects of medical devices. The majority of medical devices obtain marketing clearance in the United States through a premarket notification process, commonly referred to as a 510(k) submission.
Premarket Notification 510(K)
A 510(k) submission is a premarket application submitted to the Food and Drug Administration (FDA) to demonstrate that the device intended for marketing is as safe and effective, i.e., substantially equivalent, to a legally marketed device (referred to as the “Predicate”).
Submitters are required to compare their device to one or more similar Predicate devices and provide evidence to support their claims of substantial equivalence. The predicate device(s) used for comparison may include recently cleared devices under the 510(k) process, although any legally marketed device can serve as a predicate.
What Is Substantial Equivalence
A 510(k) submission mandates the demonstration of substantial equivalence to another legally marketed device/Predicate device in the U.S. Substantial equivalence means that the new device is equally safe and effective as the predicate.
A device is substantially equivalent if in comparison to a predicate:
- A new device aligns with the same intended use and technological characteristics as the predicate.
- It has the same intended use as the predicate and has different technological characteristics and does not raise different questions of safety and effectiveness; and
- The information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.
Who is required to submit a 510(k)?
The FDA requires following four categories of parties to submit a 510(k):
- Domestic manufacturers introducing a device to the U.S. market
- Specification developers introducing a device to the U.S. market
- Repackers or relabelers who make labeling changes or whose operations significantly affect the device.
- Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.
Step-by-Step Process for Obtaining a 510(K) Clearance
Step 1: Search for a Predicate Device (Device Class, Product Code, and CFR Regulation)
The Classification of a device can be found by performing a search on the Product Code Classification Database.
The classification database will provide the classification panel (e.g., orthopedic devices), common name, product code, and CFR regulation, if the device type has received final classification by FDA.
Once the classification of the device has been determined the user can start searching in the 510(k) database for predicate devices. Manufacturers must identify a primary predicate device that is most similar to the device under review in terms of indications for use and technological characteristics.
Selection of submission type
A submitter may select from three types of Premarket Notification 510(k) submissions to seek marketing clearance for their device when suitable for review under the 510(k) Program:
- Traditional 510(k): used for any original 510(k) or for a change to a previously cleared device under 510(k).
- Special 510(k): for changes to their own existing device if the method(s) to evaluate the change(s) are well-established, and when the results can be sufficiently reviewed in a summary or risk analysis format.
- Abbreviated 510(k): Device manufacturers may choose to submit an Abbreviated 510(k) when the submission relies on: (FDA guidance document(s), Demonstration of compliance with special control(s) for the device type, or Voluntary consensus standard(s).
Step 2: Preparation of 510(K) File
The 510(k) is not a form. The information should be provided in an organized, tabulated document. The 510(k) should provide sufficient detail for FDA to be able to determine that the device is substantially equivalent (SE) to another similar legally marketed device(s).
Step 3-Payment of Fee
Fees for Fiscal Year 2024 (October 1, 2023, through September 30, 2024) are:
- Standard Fee – $21,760, Small Business Fee: $5,440
Step 4: 510(K) Submission Process and Review
Submission of 510(k) through online via eSTAR and eCopy Submissions. eSTAR means electronic Submission Template and Resource (eSTAR) is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission.
Starting from October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR.
Acknowledgement of Receipt
| Day 1 | The FDA receives 510(k) application. |
| Within 7 days | The FDA sends an Acknowledgement Letter in case the proper user fee is paid and a valid eCopy or eSTAR is provided. If not, the FDA sends a hold letter for unresolved issues. |
| By day 15 | The FDA conducts an Acceptance Review. FDA informs the applicant if 510(k) is accepted for Substantive Review or placed on RTA Hold. |
| By day 60 | The FDA conducts a Substantive Review. The FDA communicates Substantive Interaction with the applicant that indicates whether the FDA will proceed with an Interactive Review or ask for Additional Information. |
| By day 90 | The FDA sends final MDUFA Decision on 510(k). |
| By day 100 | If an MDUFA Decision is not reached by day 100, the FDA provides a Missed MDUFA Decision Communication that identifies any outstanding review issues. |
Once 510(k) is submitted via eSTAR or eCopy, the FDA assigns a unique control number (the “510(k) number”), starting with “K” followed by 6 digits. If the proper user fee isn’t paid or a valid eSTAR/eCopy isn’t provided, the FDA sends a Hold Letter within 7 days of receipt of the 510(k). The submitter then has 180 days to resolve issues, or the 510(k) is withdrawn. If the fee is paid and eSTAR/eCopy provided, an Acknowledgment Letter will be sent. eSTAR submissions aren’t subject to refuse-to-accept (RTA) but undergo virus scanning and technical screening. Incomplete eSTAR submissions prompt an email notification; the 510(k) is held until a complete replacement is submitted within 180 days. Within 15 days of submission, an electronic notification of the Acceptance Review is received.
Substantive Review (including Substantive Interaction and Interactive Review)
During Substantive Review, the Lead Reviewer conducts a comprehensive review of the 510(k) submission and communicates with the submitter through a Substantive Interaction, which should occur within 60 calendar days of receipt of the 510(k) submission.
Interactive Review: If the Lead Reviewer chooses to continue with an Interactive Review, this means the Lead Reviewer has determined that any outstanding deficiencies may be adequately addressed within the Medical Device User Fee Amendment (MDUFA) timeframe and that the submission will not be placed on hold. The Lead Reviewer communicates with the submitter during the Interactive Review using tools such as:
- Telephone Call
Additional Information (AI) Request
If the Lead Reviewer sends an AI Request, the submission is placed on hold. The submitter has 180 calendar days from the date of the AI Request to submit a complete response to the AI Request. If FDA does not receive a complete response to all deficiencies in the AI Request within 180 days of the date of the AI Request, the submission will be considered withdrawn and deleted from our review system.
Step 5: 510(K) Decision Letter
The FDA aims to reach MDUFA Decision for 510(k) within 90 FDA Days. FDA Days are calculated as the number of calendar days between the receipt date of the 510(k) and the date of the MDUFA decision, excluding any days the submission was on hold due to an AI request. MDUFA Decisions for 510(k) submissions include findings of substantially equivalent (SE) or not substantially equivalent (NSE). Upon reaching a decision, the FDA will send the decision letter to the submitter via email, using the email address provided in the 510(k) cover letter.
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