US FDA 510(k)

We are a team of expert regulatory experts who have been assisting medical device manufacturers like you in their FDA 510k applications for decades. This page attempts to serve as your guide in the crucial 510k process for your medical device. If you are looking to enter the US market, our experienced consultants can assist you in that process.

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FDA 510(k) Overview

  • Like any government in the world, the US government also wants to ensure that its citizens don’t get low-quality or less effective medical devices when they are in need. Hence, the FDA (Food and Drug Administration) has taken up the responsibility of the whole compliance process through the medium of 510(k).
  • If you are a medical device manufacturer and have plans to voyage in the US market with your medical device, then this will be an important information source for you.
  • The Main aim is to prove that a new medical device applying to enter the US market is equivalent(or somewhat similar) to an existing approved device(in the US).

FDA 510(k)
  • Now let’s see the definition: 510(k) is a formal technical file containing essential information to prove that your medical device is (at least) as effective and safe as a legally marketed device (that is not subjected to PMA (Pre-Market Approval).
  • Through the essential barrier of 510k, the FDA wants to broadly make sure 3 essential ingredients :
  • (i) Your device is similar (substantially Equivalent )to an already existing predicate device
    (ii) in-depth technical, safety, and performance analysis of your device to show its effectiveness
    (iii) you have a robust medical device quality and risk management system.

 Who Needs to Comply with it?
  •  Organisations who wish to launch Class I, II, and III devices (which are intended for human use) in the US market, and the device is not subject to Pre-Market-Approval.

Technical Team

Our talented pool of experienced and competent FDA 510k consultants will always be there to serve you. We have the right tools and expertise to help you out in every regulatory step of your application process.

Document Control

We ensure and respect the confidentiality of your documents using instruments like Non-Disclosure Agreements (NDAs) and our data security system is ISO/IEC 27001:2013 certified.

Cloud Documentation

Cloud-based documentation offers the benefit of updating and accessing your files securely from anywhere. This ensures that you are at ease once you appoint us.

Role of Cert3global Consultants

  • At Cert3Global, our extensive experience with FDA 510(k) submissions sets us apart.
  • With an 85% success rate, we have helped many manufacturers pass through the 510(k) approval process and know what exactly is needed to get through it.
  • With our proven track record of 350+ clearances worldwide, we have the right ingredients to help you in the process.
  • We tailor our service to best serve manufacturers keeping in consideration their device details and regulatory competence and expertise, you can trust Cert3Global to navigate the complexities of FDA submissions with confidence.

What is a Predicate Device?

Simply put, it is an existing & approved medical device that is being legally marketed in the US market already and in your 510(k) application, it is used as a point of comparison for seeking approval for your medical device.

Why Do Manufacturers Need to Show a Predicate Device?
To Demonstrate that their new device is “substantially equivalent” to a device already marketed in the US market. This helps manufacturers in seeking approval through the FDA 510k clearance pathway.

What are the essential ingredients for a device to be considered as a ‘Predicate’?
To be considered in the 510(k)application process, the Predicate Device should have :
(i) the same intended use (as the new device seeking approval)
(ii) similar technology in the functioning and operation of the device
(iii)the same level of safety and efficacy

What are the types of Predicate Devices:
(i)Pre-amendments Device: marketed in the US before Medical device amendments in 1976 and did not require the 510(k)
(ii)Post amendments: Devices that were marketed after Medical device amendments in 1976 through 510(k) or Pre-Market Approval

What is Substantial Equivalence?

Compared to Predicate (which is almost “identical”), it is a bit more loose term. From a medical device manufacturer’s perspective, offering identical devices will hardly have any competitive advantage/difference. Often 510(k) submissions are rejected because the device fails to prove “Substantial Equivalence”.Hence it is a critical checkpoint in your 510(k) application.

  • same intended use as the predicate.
  • same technological characteristics as the predicate.
  • different technological characteristics but don’t raise different questions of safety and effectiveness.
  • The information submitted to the FDA proves that the device is as safe and effective as the predicate. Any irregularity found in Data related to substantial equivalence can lead the manufacturer to resubmit the required data (by FDA) or if not proved, then the device manufacturer has to apply through the route of ‘DeNovo (a new category of device)’ or ‘Pre Market Approval (PMA)’Hence, an experienced and competent consultant service like Cert3global can help you out by ensuring your device meets the criteria of substantial equivalence.

What are the Types of FDA 510(k)

  • This original submission is typically required for medical devices requiring FDA clearance, according to 21 CFR 807. It can also be used for submissions involving changes to previously cleared devices.
  • If the medical device:
    (i)does not require PMA [Pre-Market Approval]
    (ii) is original and not have been cleared before

  • It is an alternative pathway to the clearance process and includes all standard sections of tradition.Applicable when : 
  • 1) FDA Guidance exists for specific device types or when compliance can be demonstrated using FDA-recognized consensus standards.
    2) The device makers can add summary reports on guidance documents, and conformity to recognized standards to demonstrate substantial equivalence or compliance with special controls.

  • If a manufacturer already has a cleared device marketed legally through traditional 510(k), but now has made significant changes to their device, then they have to go through the special 510(k) route.
  • Changes may include indications of use, design, and labelling if they do not affect the safety or performance of the modified device and established evaluation.
  • If more than two functional areas of expertise are modified, then special 510(k) is not an option.