FDA 510k PREMARKET NOTIFICATION
A 510k is a premarket submission made to FDA that demonstrates the device to be sold is as safe and effective, that is, substantially equivalent, to a legally marketed device. A technical file, known as 510(k), needs to be submitted to the FDA for devices meant to be used on humans.
A 510(k) submission must be made for devices that do not need a Premarket approval (PMA) and are not exempt from the 510(k) requirements by manufacturers of medium-risk medical devices or IVD who wish to market their devices in the U.S. The 510(k) submission or premarket submission includes technical, performance and safety information about the medical device.
Once 510(k) clearance is obtained from FDA, the manufacturer can legally market the medical device in US market.
Shorter review time (if the data submitted is accurate, the review time is about 90 days).
Most 510(k) submissions do not need clinical data.
Review fee is much lesser than that for PMA.
An FDA 510k is required for introducing most Class II medical devices, some Class I and Class III devices and IVDs in the U.S. market, a 510(k) submission needs to be made by:
- A U.S. manufacturer wishes to introduce a finished medical 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 device’s condition is affected.
- Foreign manufacturers or exporters
The Premarket approval (PMA) is the regulatory pathway chosen for class III devices used to sustain/ support human life and present substantial risks. This method is used to prove the safety and performance of a new medical device using data obtained from laboratory testing and clinical trials with human participants in most cases.
HOW TO APPROACH FDA FOR A 510K CLEARANCE?
The medical device 510k process consists of the following steps:
- Confirm the classification of the medical device and if the device needs 510(k).
- Identify the product code, device classification and regulation number of the medical device based on its intended use.
- Find a suitable predicate device that is substantially equivalent to the proposed device for the intended use, material composition, fundamental scientific technology, principles of operation, and basic design.
- Demonstrate that the proposed device is at least as safe and effective as the identified predicate device to prove the substantial equivalence to the predicate device.
- Prepare the 510(k) file.
- Make the 510(k) review fee payment and submit it to FDA.
FDA will send a confirmation whether the submission is accepted for review in about 2 weeks. The evaluation of substantial equivalence by the FDA generally takes 90 days and is based on the information found on the data submitted. But, it may take longer if a Refuse-to-Accept or Additional Information letter is issued, the reply to which needs to be submitted within 180 days.
Once the review is completed successfully, a 510(k) clearance letter with a unique 510(k) number for the device will be sent by the US FDA, along with a copy of the device’s approved Indications for Use.
PROCESS OF 510K CLEARANCE
A 510(k) clearance is the status granted by the US FDA to a medical device at the end of the review of the premarket or 510(k) submission if the manufacturer can successfully establish that the device undergoing review is at least as safe and effective as the chosen predicate device.
A clearance letter with a unique 510(k) number for the device along with a copy of the device’s approved Indications for Use will be sent by FDA once 510(k) clearance is obtained. The manufacturer can then legally market the device in the US.
How do I file a 510k with FDA?
To file the 510(k) submission with FDA, the following steps will have to be followed:
- Confirm the classification of the medical device and if the device needs 510(k).
- Identify the product code, device classification and regulation number of the medical device based on its intended use.
- Find a suitable predicate device that is substantially equivalent to the proposed device.
- Register the manufacturer and device on Establishment Registration and Device Listing.
- Prepare the technical file containing all the necessary details to demonstrate the safety and effectiveness of the proposed device by establishing substantial equivalence to the predicate device chosen. The 510(k) submission should also contain all the information related to the device’s design, development, testing, etc.
- If you have any queries and clarification are required, apply for the pre-submission program to obtain feedback from the FDA for a potential or planned medical device application before the actual 510(k) submission. The pre-submission process may take up to 120 days to complete.
- Once the competing 510(k) file is prepared, pay the 510(k) review fee and submit the file to FDA.
- The evaluation of substantial equivalence by the FDA generally takes 90 days and is based on the information found on the data submitted.
- But, it may take longer if a Refuse-to-Accept or Additional Information letter is issued, the reply to which needs to be submitted within 180 days.
WHAT KIND OF DOCUMENTS AND WHERE TO SUBMIT THE 510K?
The 510(k) file includes documents used to establish the safety and efficiency of the proposed medical device through substantial equivalence. 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 document includes basic administrative and device information.
- 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 summary of the device undergoing the 510(k) clearance.
- Truthful & Accuracy Statement: This is to certify that the 510(k) submission contents are truthful and accurate and no information omitted.
- Class III Summary and Certification: If the proposed device is a Class III 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: Lists the voluntary consensus standards used and includes DOC to such standards.
- Device Description: This document includes the description of the device design requirements and performance specifications.
- Executive Summary: a brief description of the device & comparison table with the predicate device identified.
- Substantial Equivalence Discussion: Detailed comparison between the proposed device and the predicate device chosen.
- Proposed Labeling: Is discussed in detail 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- If the proposed device is powered electrically, in which case the EMC 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.
- Performance Testing – Clinical: This document included details of the clinical studies performed to evaluate the efficiency of the proposed device.
The completed FDA 510(k) file is submitted in electronic format as an e-copy to the FDA. The submission package is sent to the CDRH through registered mail or commercial delivery service.
FDA 510(k) REVIEW PROCESS
Detailed below the FDA process once the review fees and 510k file is uploaded
Day 1: FDA receives 510(k) application
By day 7: Acknowledgement letter send by FDA. If there are any issues with the application, Hold letter is sent
By day 15: Acceptance review is conducted and FDA informs the applicant if the submission has been accepted for Substantive Review or placed on RTA hold.
By day 60: Substantive review completed and will inform applicant if any Additional Information (AI) is needed or Interactive Review is required to clarify any pending issues.
By day 90: 510(k) Decision letter is issued. If the device is found to be substantial equivalent to the chosen predicate, the device is said to be 510(k) cleared.
By day 100: If a decision cannot be reached by day 100, FDA will issue a Missed MDUFA communication, which informs the applicant about any pending issues that is affecting the review process.
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A medical device that is legally marketed in the US and that can be used to prove the performance and safety of a similar medical device that is seeking clearance from FDA is known as a predicate device. The information of predicate device can be used to demonstrate the effectiveness and safety of the medical device seeking 510(k) clearance.
Substantial equivalence is used to establish the safety and effectiveness of a new device by comparing it to another legally marked device known as predicate device. The new device is considered to be at least as safe and effective as the predicate device, if it is proven to be substantially equivalent to the predicate device. The two devices need not be identical to each other to be substantially equivalent. The predicate device can be a pre-amendments or post-amendments device that is or was legally marketed in the US. Various factors like intended use, materials, design, safety, performance, biocompatibility etc. can be used for this purpose.
A 510(k) number is a unique number assigned to a medical device undergoing the process of premarket submission to obtain the clearance for sale in the US. The 510(k) number is assigned when the 510(k) file is submitted by the applicant for review by the FDA. This number is used to track all further communications with the FDA during the process of the review to establish substantial equivalence.
Once the review is completed successfully, a clearance letter is sent by the FDA with this 510(k) number for the device along with a copy of the device’s approved Indications for Use. This number can then be used to access the details about the medical device from the FDA database.
The medical devices which does not need to undergo 510(k) clearance to give assurance of its safety and performance are generally exempt from 510(k) by FDA. The following types of devices may be exempt from 510(k) requirements:
- Pre-amendments devices
Class I and Class II devices that have been specifically exempted by FDA.
The medical device classification system is used for assessing potential risk and subsequent regulatory pathway required to ensure quality standards are being met by the medical device.
Medical devices are classified into 3 groups:
Class I: Low to moderate risk
Class II: Moderate to high risk
Class III: High risk
DUNS number is the unique nine-digit identifier for a businesses. This was created and managed by Dun & Bradstreet and is the standard numbering system to identify businesses across the globe.
Clinical data is the data obtained through investigations performed by using the medical device to prove the safety and effectiveness of the device under study. The study is generally performed on humans considering the intended population of the device.
This data is used to demonstrate that the device performs as intended, is safe and that any risk posed by the device outweighs the benefit it offers to the patients. Clinical data is needed for mostly high risk devices.
Establishments or manufacturers involved in production of medical devices must register with FDA to market their medical devices in the US. The annual registration fee must be paid by these establishments. The fee for the fiscal year 2022 is $5,672.
The medical devices manufactured by these registered establishments are listed with FDA along with the activities performed on those devices. This is called device listing. Each device listed with the FDA are provided with a listing number.
Financial Certification or Disclosure Statement is one of the sections of 510(k) submission that mentions a single statement like “This section is not applicable as no clinical studies were performed to test this device” if no clinical studies are performed. If performed clinical studies on the device the FDA has provided the two forms for use.
The forms are:
Form FDA 3454 – Certification: Financial interests and arrangements of clinical investigators.
Form FDA 3455 – Disclosure: Financial interests and arrangements of clinical investigators.
The Financial Certification is required if the applicant did not pay the clinical investigators. It means payment done only for the costs of the study, there is no integrity or payment of any other kind (such as a grant) given to the clinical investigators.
The Disclosure Statement is used if the applicant paid the clinical investigators. Part of that form includes submitting the details of how the applicant mitigated any bias.
The manufacturer should comply with the 21 CFR 54 Financial Certification or Disclosure Statement requirements for 510(k) submission.