In this article, we are going to take you through the 3 types of 510k – Traditional 510(k), Abbreviated 510(k), and Special 510(k).
If you are planning to market newly manufactured medical devices then you must consider the Food and Drug Administration (FDA) 510(k) premarket notification. According to the FDA, 510(k) refers to the premarket submission of medical devices to the federal agency so that they can verify them as effective, safe, and substantially equal to any other legally marketed medical device.
Based on the assessment, medical devices are classified as Class I or II as per their risks. Medical device manufacturing devices can choose from the three types of 510k based on their type of medical device. These three categories include special 510k, traditional 510k, and abbreviated 510k. Let us look deeper into these types to determine which would suit your business requirements.
Understanding Special 510(k) Program
According to the FDA, special 510k refers to the optional program for 510(k) clearance when manufacturers make specific device changes to its already approved device. If the manufacturer’s design control procedures consistently provide reliable results, these can help establish substantial equivalence (SE) alongside other 510(k) requirements.
Note: The special 510k program was developed in 1998 as an alternative to the traditional 510k pathway.
When do you require the special 510k? (Understanding Types of 510k)
You can apply for the special 510k program when you want approval for the changes made in the already-marketed device. However, before applying for this program you must consider the following factors:
⦿ The changes must be made to the company’s own manufactured and 510k-cleared device.
⦿ A clear reason explaining the irrelevance of performance data for the changes made in the device must be submitted in case you submit changes without new testing
⦿ Performance data must be legible to be reviewed as a summary or risk-analysis format.
⦿ A well-established and evaluable method must be followed to make the changes.
Required documents for special 510(k)
You must have the following documents in hand before applying for the special 510k program:
⦿ A cover letter
⦿ The name and 510(k) number of the existing device.
⦿ A detailed description of the device changes prompting the new 510(k) submission.
⦿ A comparison of the modified and cleared devices.
⦿ Any other changes to labeling or design.
⦿ A summary of design control activities.
⦿ Identification of required verification and/or validation activities based on risk analysis. Indications for use form.
⦿ A statement confirming compliance with 21 CFR 820.30 design control requirements and availability of records for review upon request.
What is the review timeline for the special 510k program?
According to the FDA 510k guidelines, special 510k submissions are reviewed within 30 days of receipt. However, if the FDA does not approve your modified medical device for a special 510k, they will automatically convert your submission to a traditional 510k. The FDA sends an additional Refuse to Accept (RTA) notice after the conversion since a special 510k does not comprise all the required information that a traditional program requires. You must keep this in mind when choosing a special 510k.
Learn more about the FDA’s special 510k guidance from their official website.
Understanding Abbreviated 510(k) Program
The FDA also introduced the abbreviated 510k program in 1998 as an alternative to the traditional 510k program. This FDA clearance program requires you to include all the sections of the traditional 510k program.
However, you can provide synopsis reports as a “paper comparison” to demonstrate adherence to guidance and standards during abbreviated 510k submission. In simpler terms, the abbreviated 510k program allows you to prove substantial adherence/equivalence of a device via standards. Therefore, you can save time and resources on additional testing or argue using a predicate device to prove substantial adherence/equivalence.
When do you require the abbreviated 510(k)?
You may require the abbreviated 510k program if you have:
⦿ Summary reports comprising the usage of FDA guidance documents for establishing substantial equivalence to an existing device type.
⦿ Synopsis reports proving compliance with device-specific special controls.
⦿ A Declaration of Conformity (DOC) to voluntary consensus standards from 32 organizations like ANSI, IEEE, ISO, and other 29 standard-regulatory organizations. The FDA has a database of recognized consensus standards.
What is the timeline for abbreviated 510k?
The FDA requires a 90-day response time for abbreviated 510k submissions. However, this may vary in case the FDA refuses the abbreviated 510k submission for your device.
You can check the complete timeline here US FDA’s 510(k) Submission & Review Process
How does abbreviated 510k differ from traditional 510k?
Although these two types of 510(k) programs may seem quite similar, they have some differences that set them apart.
Approval time: Although the term abbreviated may suggest otherwise, both types of 510k programs take the same approval time.
Cost: Both types of 510(k) programs have the same costs.
Documentation: These two types of 510(k) programs differ when it comes to documentation. While the traditional program requires detailed documentation, abbreviated 510k requires summarized reports on standard compliance with DOC. Therefore, an FDA reviewer may take less time to review abbreviated 510k documents and make faster decisions.
Process: Traditional and abbreviated 510k submission or approval processes do not differ. Both types of 510(k) programs must follow the same submission and approval formats including the chapter and the structure.
You may learn more about the abbreviated 510k program from the FDA’s official website.
Understanding Traditional 510(k) Program (One of the types of 510k)
The traditional 510k is the most common among the types of 510k programs. It refers to the program that manufacturers must follow to provide substantial equivalence for their newly manufactured medical devices. Around 79% of manufacturers make traditional 510k submissions before marketing their new devices.
When is Traditional 510(k) Required?
Traditional 510k can be required when you want to market a newly manufactured device without 510k clearance and that does not need the PMA process. You may also require it to approve changes to cleared devices that don’t qualify for a special 510(k).
Documents Required for Traditional 510k
For traditional 510k (one of the types of 510k) you require must have the following documents:
⦿ A cover letter.
⦿ An index comprising contents with page numbers for each section.
⦿ 510k acceptance checklist for the chosen type of 510k program selected.
⦿ A guide for the right usage of the device and who should use it.
⦿ A synopsis report of your substantial equivalence argument.
⦿ Submission certificate stating your submission’s accuracy and truth.
⦿ Your device’s proposed labeling.
⦿ Comprehensive device specifications with descriptions, diagrams, engineering drawings, and illustrations.
⦿ Differentiation between your device and the predicate one for substantial equivalence establishment.
⦿ Performance data from clinical to nonclinical test results.
⦿ Add any other required items for your device type.
What can be the outcomes of a Traditional 510k Submission?
The FDA can provide the following two determinations for your traditional 510k submission:
⦿ Substantial Equivalence (SE): SE means your device is approved for distribution in the US market.
⦿ Not Substantially Equivalent (NSE): If the FDA determines that your device is NSE to the predicate one then you cannot revise your device and resubmit for another clearance opportunity. You can either prepare and submit a new 510k program using a new predicate device or apply for a De Novo request.
Traditional 510k Submission Review Process
Among other types of 510k submissions, the FDA responds to traditional 510k requests within 90 days of receiving the receipt. However, the FDA may pause the review process due to the requirement for additional information.
The step-by-step overview of the traditional 510k submission review process looks like this:
⦿ Within 7 days, you may receive an acknowledgment notice for your submission receipt. This notice will include a unique 6-digit K number and the submission date from the FDA.
⦿ Within another 15 days, the FDA will send you the results of their initial acceptance review, that is, accepted or RTA. The initial acceptance review checks if you have submitted all the necessary elements and documents for a substantive review of your device.
The FDA may provide an RTA notice if they find any problem related to your 510k submission. You have to address these problems within 180 days to resume the review process.
⦿ Once the FDA accepts your submission, they move on with the substantive review phase. The FDA will contact you within another 60 days for the next step of the process, that is, a substantive interaction.
This interaction process has two methods. First, they will contact you via email or phone call for an interactive interview. In this interview, they will request you to provide answers to any questions they might have. Second, they may request additional information (AI).
In case you receive an AI request, you will have to provide them with all the necessary information within 180 days to resume the review process.
⦿ Within 90 days, the FDA will provide the declaration of a SE or NSE for your manufactured medical device.
Conclusion
Navigating the FDA’s 510k premarket notification can be challenging, especially with three types of 510k programs to choose from. Each program has its unique requirements and timelines.
This article has covered as much as possible about these types of 510(k) programs. To make the right choice, we recommend consulting with a regulatory and quality compliance expert who can provide valuable guidance on selecting the right program and streamlining the submission process. They can help understand the differences, ensure compliance, and optimize chances for timely approval.
With the right support, you can efficiently bring your medical devices to market while meeting FDA standards.
How can Elexes help you with different types of 510k?
Elexes Medical Consulting is one of the popular and trusted names in the regulatory and quality compliance industry. With over 50+ years of experience, our team of professionals has helped 200+ clients worldwide to streamline 501(k) submission and approval processes with their expertise and unbiased assistance. We have assisted major companies in the biologics, food, medical device, and pharmaceutical industries to get timely approvals for their breakthrough innovations. Contact us today and get your device on the market on time!
