US FDA 510 K Submission – How to prepare a 510 K File?

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Food and Drug Administration (FDA) is the legal authority to establish rules and regulation for the use of medical devices within the United States. According to Food, Drug, and Cosmetic Act products falling within the scope of medical devices, shall be registered in FDA database. In that sense, FDA 510 K clearance is required for Class II devices before registration. If you aim FDA 510 K Submission, the summary given below might be useful for you.

Medical devices are divided into three classes (Class III, II and I) by FDA. Premarket notification process, known as a 510 K submission, is required of Class II devices. During this process, the main task is a technical file preparation. This file shall demonstrate that the device to be marketed is at least as safe and effective as the a legally marketed device. In this, so called “substantial equivalence discussion”, context, the terms predicate device and subject device are often used to distinguish the legally marketed device and candidate device. Under certain circumstances, submitters may compare their device to one or more predicate devices to support their substantial equivalency claims.

Basic Steps of a 510 K Submission

Step 1 – Identification of Product Code & Regulation Number

To define the requirements related to your device, first you must identify the product code and regulation number. You can start a simple search on FDA Database till you find the regulation number for which the identification matches the intended use of your device. The search the similar devices on the market and compare their technical specifications and intended use with your device could be a good starting strategy.

FDA product codes consists of 3 letters. Knowing this code, on product classification database you can locate the regulation description and number, device class, GMP requirements, recognized consensus standards and other useful information.

Step 2  – Select the Submission Type

As detailed on the FDA 510 K Submission Programs web page, a submitter may choose from three types of submissions to seek marketing clearance for a medical device. These are called Traditional, Special, and Abbreviated 510 K.

The traditional 510 K submission would be the best choice, if you are preparing your first submission.

You may choose Special 510 K for submitting changes to an existing device. The main criteria for a Special 510 K are to have well-established methods to evaluate the changes. The results shall be sufficiently reviewed in a summary or risk analysis format.

If your device design complies with voluntary consensus standards or you can demonstrate compliance with special control(s) for the device type, you may select an Abbreviated 510 K. In this case your submission must rely on the related FDA Guidance documents.

FDA performs the substantive review in 60 days after the receipt of the 510 K Submission. There are two possible outcomes of this review. FDA will either proceed with Interactive Review (e-mail or telephone call) or the submission will be placed on hold and Additional Information (AI) will be requested.

Step 3 Select a Predicate Device to use in your 510 K Submission

Selection of a predicate device is one of the outmost important steps in the preparation process. You should select a primary predicate device which has the most similar indications for use and technological characteristics to your device. Of course it should have the same product code and regulation number. If you need to identify more than one predicate device to demonstrate substantial equivalence, you should clearly justify your reasoning. You can find further details on the FDA guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]”

Step 4 Prepare your 510 K Submission

The content of a 510 K submission shall be prepared in an auditable format. The appropriate acceptance checklist for 510 K and FDA website about Content of 510 K include extremely useful information. You may benefit from these resources during your technical file preparation.

We recommend that you divide your 510 K Submission into sections and prepare an effective table of content, which will guide the lead reviewer during review process. Of course, the sections can be different according to the type and specification of your medical device, but the below list may be used as a sample.

  • Section A – Administrative Issues
  • Section B – Executive Summary
  • Section C – Device Description
  • Section D – Substantial Equivalence Discussion
  • Section E – Proposed Labelling and IFU
  • Section F – Shelf Life
  • Section G – Biocompatibility Evaluation
  • Section H – Software Validation
  • Section I – Electromagnetic Compatibility and Electrical Safety
  • Section J – Performance Testing 

Step 5 Pay the Fees and Submit

To submit your 510 K file, you need to create an account for your company. After login, you can pay the required 510 K application fee and submit your file to FDA’s Center for Devices and Radiological Health (CDRH). Since December 2019 only one eCopy is required by FDA. The details of the FDA eCopy program can be found on the “eCopy Program for Medical Device Submissions” webpage.

For a successful preparation phase an extensive gap analyses against the above-mentioned requirements and guidance documents would be extremely useful. In addition to this a robust risk management process, which is aligned with ISO 14971 (recognized consensus standard by FDA) would also be beneficial to demonstrate the safety of your medical device. This will enable to define the possible gaps with the safety and performance requirements to the predicate device. In some cases design changes, further testing or validations could be required.

If you need help to define your roadmap for a successful 510 K file submission, do not hesitate to contact our experts and request a preliminary meeting.