An FDA 510(k) is the technical dossier that needs to be submitted to the US Food and Drug Administration (FDA) for devices meant to be used on humans. A 510k submission must be made for devices, which do not need a Premarket approval (PMA) and are not exempt from the 510(k) requirements, by manufacturers who wish to market their medium-risk medical device or IVD in the U.S.
The 510(k) submission is also known as a Pre-market Notification. This includes technical, performance and safety information about the medical device.
When is a 510k clearance required?
To introduce most Class II medical devices, some Class I and Class III devices and IVDs in the U.S. market a 510k submission needs to be made by:
- A U.S. manufacturer wishes to introduce a finished device.
- A specification manufacturer develops the specifications for a device but manufactures the device under contract with another firm wish to introduce the device.
- Re-packagers and re-labellers if a significant change is made in the labelling or if the condition of the device is affected.
Foreign manufacturers or exporters
To introduce most Class II medical devices, some Class I and Class III devices and IVDs in the U.S. market a 510k submission needs to be made by:
- A U.S. manufacturer wishes to introduce a finished device.
- A specification manufacturer develops the specifications for a device but manufactures the device under contract with another firm wish to introduce the device.
- Re-packagers and re-labellers if a significant change is made in the labelling or if the condition of the device is affected.
Foreign manufacturers or exporters
A 510k consultant can help with FDA 510k application by:
- Preparing templates required for the regulatory documents.
- Provide guidance on which performance tests need to be performed
- Identifying bio-compatibility tests that need to be performed
- Review of protocols and study reports send by the lab after the tests
- Review the labelling and provide necessary guidance to ensure the labelling complies with the FDA requirements.
- Identify suitable predicate devices and prove the substantial equivalence to the proposed device.
- Completion of all regulatory documents as per FDA requirements.
- Review and correction of the device drawing and manufacturing flow chart.
- Help the manufacturer prepare the necessary risk management files.
Provide guidance if clarifications (if any) has to be given to the FDA
The main requirements to be fulfilled in a 510(k) submission can be divide into:
- Identifying the product code and regulation number: Product code is a unique code that matches the actual product name and/or the description of the device given in the invoice. It is used to identify a specific product and normally is combination of 3 letters. Each product code is placed into a generic category based on the classification regulation. The method to identify and classify the device is provided in the regulation.
- Classification of proposed device: Medical devices are classified into Class I, II or III depending on the regulation number and product code associated with it to guarantee its safety and effectiveness.
- Identifying suitable predicate device: A medical device which is legally marketed in the US and can be used as a point of comparison to prove the performance and safety of the proposed medical device that is seeking FDA clearance is known as a predicate device.
- Establishing substantial equivalence: The successful 510(k) submission depends on proving substantial equivalence of the proposed device with respect to a predicate device. Substantial equivalence is used to establish the safety and effectiveness of a new device by comparing it to a predicate device. The product details of predicate device, if proven to be substantially equivalent, can be used to demonstrate that the medical device seeking clearance is as safe and effective as the predicate device.
- Performance testing: The performance tests as suggested in the FDA guidance (if available) and mentioned in the predicate device should be performed and the acceptance criteria should be met to ensure the effectiveness of the proposed device.
- Biocompatibility testing: The biocompatibility tests should be planned if the proposed device comes into direct or indirect contact with human tissue. The biocompatibility tests are conducted as described in the FDA guidance, Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing and according to ISO 10993-1:2018, Biological Evaluation of Medical Devices – Part 1, Evaluation and Testing within a Risk Management Process. The device should be proved to be biocompatible to human tissue.
- Regulatory documents: All documents must be prepared in accordance with the FDA requirements. Any additional details that are to be submitted can be included as annex. Please refer https://www.fda.gov/media/130647/download for the format 510(k).
The 510(k) file consist of a set of documents that is used to demonstrate the safety and efficiency of the proposed medical device. The documents included in the 510(k) file are:
- Form FDA 3601: Medical Device User Fee Cover Sheet (MDUFC sheet)
- FDA Form 3514- CDRH Premarket Review Submission Cover Sheet: This provide basic administrative information for all types of premarket notification submissions.
- 510(k) Cover Letter: This document provides a brief idea about the purpose of the submission, device, manufacturer and the U.S agent (if any).
- FDA Form 3881: Indications for Use Statement
- 510(k) Summary or 510(k) Statement: This includes a brief summary of the device included in the 510(k) and the supporting information.
- Truthful and Accuracy Statement: this is a declaration certifying that the information submitted in the 510(k) is truthful and accurate and that no omissions of material facts have been made.
- Class III Summary and Certification: This is applicable only if the proposed device is a Class III device exempt from PMA otherwise this can be marked as not applicable.
- Financial Certification or Disclosure Statement: This is applicable only if clinical studies were conducted
- Declarations of Conformity and Summary Reports: This document lists the voluntary consensus standards used and includes declarations of conformity to such standards or the basis for its general use.
- Device Description: This document includes the description of the device design requirements and performance specifications.
- Executive Summary: This is a very important document which includes a brief description of the device and comparison table with the predicate device identified. The performance testing summary is also included in this document.
- Substantial Equivalence Discussion: This document gives a detailed comparison between the proposed device and the predicate device chosen. The similarities and dissimilarities are discussed and the substantial equivalence is established.
- Proposed Labeling- The proposed labeling in discussed in detail here to comply with 21 CFR 807.87(e) for general medical devices and 21 CFR 809.10 for IVD’s
- Sterilization and Shelf Life: This document provides details regarding the sterilization and shelf life claim being made.
- Biocompatibility: This document is applicable if the proposed device comes into direct or indirect contact with the human body tissue.
- Software: This includes the documentation for any software used in the proposed device
- Electromagnetic Compatibility and Electrical Safety- This document is included if the proposed device is powered electrically, in which case the electromagnetic compatibility must be evaluated.
- Performance Testing – Bench: This document included details of the bench tests performed to evaluate the efficiency of the proposed device.
- Performance Testing – Animal: This document included details of the animal testing performed to evaluate the efficiency of the proposed device.
The activities are divided into two phases
- Technical Documentation or 510k preparation
- FDA Review and Approval
Technical Documentation or 510k preparation : Depending on the device complexities, applicants team capabilities and processing of external testing labs the timeline varies between 3 months to 5 months.
FDA Review and Approval : Depending the number of pages, quality of the submitted file the review and back – and – forth file submission takeaway between 6 to 12 months.
| I3CGlobal Fees |
| Electrically Operated Devices |
450000.00 INR |
| Software Devices |
550000.00 INR |
| Non Active Devices |
650000.00 INR |
| Implant Devices |
750000.00 INR |
* The final fees after FDA product code may vary from device to device.
| Additional Expenses |
| US Agent for Submission & FDA Correspondence |
450000.00 INR |
| Biocompatablity Testing (Associated Labs) |
NA |
| Performance Testing |
NA |
| Clinical Trails If applicable |
NA |
| 510K Review Fees (Applicable for FY 20-21) |
| Turnover less than $100 million in recent tax year. |
$ 3108 |
| Turnover above $100 million in recent tax year. |
$12432 |
