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510-K Submission

FDA 510-K Clearance

What is FDA 510 k Clearance?

Every device manufacturer wishes to trade in the US market for the classified medical device Class I, II, and III. Premarket approval application (PMA) is not necessary if those are meant for human use. But must submit FDA 510 k unless the device is exempt from 510 k necessity of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), and does not overreach the circumstance of exemptions of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).

FDA 510k is a premarket approval process made by FDA to signify that the device to be marketed is at least as safe and effective, substantially equivalent, to a lawfully marketed device (21 CFR 807.92) that is not subject to premarket approval. The applicant must measure their medical device to one or more similar legally marketed devices to support their substantial equivalency claims. And important to note that FDA does not execute 510 k pre-clearance facility inspections. The applicant may market their device immediately after 510 k clearance is permitted at any time after FDA 510 k clearance.

The FDA does not “approve” FDA 510 k submissions. It “clears” them. It is not legal to advertise a 510(k) cleared device as “FDA-approved. 

  • 510 k clearance

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k).

  • US FDA 510k certification


Types of 510(k)

There are typical 3 types of 510(k) established under the US FDA clearance system. The Traditional Program is the original submission type as provided in 21 CFR 807. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of certain types of submissions subject to 510(k) requirements. These Programs were previously described in The New 510(k) Paradigm guidance.  In 2019, the FDA split “The New 510(k) Paradigm guidance into two distinct guidance documents: The Special 510(k) Program and The Abbreviated 510(k) Program. The Special 510(k) and Abbreviated 510(k) submission types can be used when a 510(k) submission meets certain factors.

Traditional 510(k):

This type of 510(k) is what is known as the original 510(k) submission or for a change/modification done to a previously cleared device under 510(k). This may be used under any circumstances.

Abbreviated 510(k):

This type of 510(k) is 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).


Special 510(k):

This type of 510(k) is considered when there is modification to a device however modification should have no effect on intended use or alter the fundamental scientific technology. Examples for these modifications can include:

  • Change in environmental specifications
  • Change in performance specifications
  • Change in ergonomics of the patient user interface
  • Dimensional specifications
  • Software or firmware

Where to start US FDA 510 k clearance Process.

FDA 510 k service is an online process, starts from classifying the devices & gathering information about the company products and then uploading them, through an online process. For class II devices, there is a process called the US FDA 510 k process or the pre-market clearance. In this, the safety & effectiveness of the device is established through substantial equivalence.

Who needs FDA 510 k and Why?

The domestic medical device manufacturers from any country trying to introduce a new device to the US market. Re-packers or Re-labellers who make labelling changes or whose operations significantly affect the device. In simple words, FDA 510 k is the name of a process, but technically it is a complicated and equally important process to submit your device documentation for clearance, to determine whether the device is safe and effective and hence permissible to legally sell in USA market.

Device identifications point for FDA 510 k

A device is considered identical only if, in comparison to a predicate it

  1. The device has to have the same intended use as the predicate; and
  2. Also, the device should have the same technological characteristics as the predicate;
  3. Deliberate use should be remaining the same as the predicate
  4. Whether the device has different technological characteristics and does not raise different questions of safety and effectiveness
  5. The data submitted to the FDA reveals that the device is at least as safe and effective as the legally marketed device.


FDA 510 k medical device approval process

State of considerable equivalence does not mean the new and predicate devices must be identical. Significant equivalence is established with respect to the intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labelling, biocompatibility, standards and other characteristics, as applicable. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the US market.

Preparation for FDA 510 k Application

Anyone who want to sell a device in the U.S. It is required to make the US FDA 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. Change in the intended use of a device which you already have in commercial distribution. If there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness. A new US FDA 510 k submission 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 for use. The medical device manufacturer which makes the products GMP non-exempted are expected to implement the 21 CFR Part 820 as a quality management system.

The products which are marked as GMP Non-exempted the quality management system as per 21 CFR Part 820. The US FDA 510 k submission shall be prepared and submitted along with the review fees, the US FDA 510 k review fees can be remarkably reduced based on the turnover. The entities including its affiliates shall have less than 100 million dollars turnover to be qualified as SBU (Small Business Unit). The review is conducted by CDRH (Centre for Devices and Radiological Health) and raises queries if any. After the successful completion of the activity, the US FDA 510 k number is approved. After US FDA 510 k approval, the Establishment registration and device listing shall be done in order to supply products in the US.

What is an Acceptance Review?

Once Acknowledge letter is sent to applicant the DCC routes to appropriate ODE or OIR division and the Lead Reviewer conducts the Acceptance Review

  • Assess if 510(k) is administratively complete using acceptance checklist

Acceptance review usually results in:

  • The 510(k) was accepted for substantive review; or
  • The 510(k) was not accepted for review (i.e., considered refused to accept or RTA); or
  • The 510(k) is under substantive review because FDA did not complete the acceptance review within 15 calendar days.


The applicant has 180 calendar days to fully address the deficiencies cited in the RTA Hold. If this is not done, the 510(k) is considered withdrawn and deleted from our review system. If the 510(k) is deleted, the 510(k) submitters will need to submit a new, complete 510(k) to pursue FDA marketing clearance for that device.

Neozenith Consulting Services is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities, the client receives the US FDA 510 k approval. We also assist with the establishment registration and device listings to make suitable the supply of medical devices in the US.

What is a Substantive 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.

The Substantive Interaction communication is typically:

  • An email stating that FDA will proceed to resolve any outstanding deficiencies via Interactive Review; or
    • Email
    • Telephone Call
    • Note: During Interactive Review, any information submitted to the DCC must include a valid eCopy.
  • An Additional Information (AI) request which places the submission on hold. 
    • The submitter has 180 calendar days from the date of the AI Request to submit a complete response to the AI Request.


Medical Device 510(k) Submission Consulting for FDA Clearance

Every year the US FDA “approves” more than 2,000 traditional medical device FDA 510(k) submissions. A significant number of additional FDA submissions are rejected or abandoned by the manufacturer because the required testing was not conducted, guidance was not followed, or other requirements were not met. 

Our experienced 510(k) consultants will increase your chances of getting FDA approval, and get it done faster

If you have a medical device that’s ready for commercialization, Neozenith can help you navigate the FDA approval (clearance) process. We specialize in medical device compliance and our team of 510(k) consultants understands how the FDA submission process works and what pitfalls to avoid. As a result, we can generally prepare and submit your 510(k) application more quickly, with less chance of receiving an initial “Refuse to Accept” (RTA) hold or an Additional Information (AI) request from the FDA reviewer. Faster clearance from FDA means your device is generating sales sooner.

We achieve positive results using a proven process for preparing your 510(k) Premarket Notification to FDA

We are meticulous about preparation, and emphasize it because we have learned that spending time on preparation results in a higher rate of successful 510(k) submissions at less overall cost to our customers. Here’s how we will approach your medical device 510(k) application:  

  1. Confirm your FDA product code, regulation number, and predicate devices. This is crucial. If the wrong product code is chosen, it can lead to rejection of your FDA 510(k) application and months of lost commercial sales. Identifying the correct predicate devices against which you will compare your device is also critical and must be done with care. 
  2. Identify all testing, FDA guidance, consensus standards, and clinical data requirements.The FDA website contains a wealth of information, but it can be overwhelming. This is where having an experienced 510(k) consultant on your side can pay off. Each product code lists FDA guidance documents and/or consensus standards associated with that device. We will research all standards and guidance documents to be followed, along with testing and clinical data requirements to be met, if applicable.  Finally, we will identify the best submission pathway for your product and business goals.  The agency has made significant changes to the Special 510(k), Abbreviated 510(k) submission pathways.  Our 510(k) consultants can cut through the complexities of the guidance’s and present a clear recommendation for your device type.
  3. Prepare a detailed gap analysis report to provide a clear pathway for 510(k) submission.With requirements identified and an assessment of your current documentation complete, we will provide you with a detailed gap analysis report showing what information you have now and the data you still need to obtain for a successful 510(k) submission. We will then educate your team on the testing that will be required along with clinical data to be collected, if applicable. 
  4. Compile and submit the FDA 510(k) application and handle post-submission questions.Once all the missing data and testing pieces have been assembled, our FDA consultant will prepare all 20 sections of your 510(k), submit it to FDA, and answer follow-up questions that arise from the FDA reviewer. “Additional Information (AI)” requests are common, but we aim to minimize these by ensuring that all sections of the 510(k) are complete and include all required data as stated in consensus standards and guidance documents. This is the point at which preparation pays dividends in the form of speedier approval.


How long it will take to clear your medical device 510(k)

Even though FDA has a published goal to clear most 510(k) submissions within 90 days, those are working days and not calendar days. Also, if the FDA reviewer issues an AI request post-submission, their internal review clock stops and does not begin again until you provide them with the requested information. As such, the majority of medical devices clear the FDA 510(k) review process in 4-8 months. Simpler devices with limited testing requirements and well-known predicates will be on the short end of that range; more complex products on the long end.