US FDA and Successful submission of traditional 510(k)
US FDA and Successful submission of traditional 510(k)
If you have an idea for a new medical device and want to sell that product in the US, you will need approval from the Food and Drug Administration (FDA). For class II devices, 510(k) is applicable whereas for class III devices, Pre Market Approval is required. For a 510(k) submission, before marketing a device, each submitter must receive an order, in the form of a letter from FDA which mentions that the device is substantially equivalent and the device can be marketed in the US.
How is 510(k) different form Pre Market Approval (PMA)
| 510(k) | PMA |
| The purpose is to provide evidence that the subject device is substantially equivalent to the predicate device that is already in the market. | The purposes to provide the safety and efficacy of new device typically through clinical trials. |
| Typically, class II devices falls under this category. | Typically, class III devices falls under this category. |
| Clinical trials are not mandatory | Clinical trials are mandatory. |
| The timeline for 510(k) process is 90 days. | The timeline for a PMA process is 180 days. |
What is a 510(k) process?
A 510(k) submission is a pre-market notification that you must submit to the FDA to sell medical device products classified as medium risk in the US market. The submission provides regulators with technical, performance, and safety information on your new medical device.
The aim of your submission is to demonstrate the medical device you have developed is “substantially equivalent” to a product (known as a predicate device) that has already been approved for use in the US. The phrase “substantially equivalent” means your product must be, as a minimum, as effective and safe as the predicate device. If your 510(k) submission achieves this aim, the FDA will clear your product for sale in the US.
Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.
As FDA does not typically perform 510(k) pre clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.
Substantial equivalence
A device is substantially equivalent if, in comparison to a predicate it:
- has the same intended use as the predicate; and
- has the same technological characteristics as the predicate; or
- 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.
Sections of a typical 510(k) dossier
Section 1.0 – Medical Device User Fee Cover Sheet (Form FDA 3601)
Section 2.0 – CDRH Premarket Review Submission Cover Sheet
Section 3.0 – 510(k) Cover Letter
Section 4.0 – Indications for Use Statement
Section 5.0 – 510(k) Summary
Section 6.0 – Truthful and Accuracy Statement
Section 7.0 – Class III Summary and Certification
Section 8.0 – Financial Certification or Disclosure Statement
Section 9.0 – Declarations of Conformity and Summary Reports
Section 10.0 – Executive Summary
Section 11.0 – Device Description
Section 12.0 – Substantial Equivalence Discussion
Section 13.0 – Proposed Labeling
Section 14.0 – Sterilization and Shelf Life
Section 15.0 – Biocompatibility
Section 16.0 – Software
Section 17.0 – Electromagnetic Compatibility and Electrical Safety
Section 18.0 – Performance Testing – Bench
Section 19.0 – Performance Testing – Animal
Section 20.0 – Performance Testing – Clinical
Review Process
The review process of 510(k) submission is divided into two parts. They are
- Acceptance review
Acceptance review takes up to 15days. In some cases, 510(k) is not accepted at the primary level. Refuse To Accept (RTA) is issued to the manufacturer. In such cases, more documentation required to validate the product.
- Substantial review
The substantial review takes up to 60 days. At this stage, the approval body may ask for additional information.
Timeline of communication for 510(k) review process
Upon review, when a decision is made, FDA will issue the decision letter to the submitter by email to the email address provided in the 510(k) cover letter.
Following clearance of your device, you must list your product with the FDA. If this is your first time selling to the US market, you will need to register your company as well. You must also pay the annual establishment registration fee to maintain your company registration.
Conclusion
510k approval is easier if you ensure whatever is done is recorded from day one. Failing on the recording part makes it inconvenient and difficult to obtain 510(k) clearances.
To find out more about the 510(k) submission process and preparing the information and documentation that you need, please get in touch with a member of the KN consulting team.
References:
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
https://www.greenlight.guru/blog/fda-510-k-submission
https://www.emergobyul.com/resources/fda-510k-quick-answers
