FDA 510(K) Submission
FDA 510(k) submissions for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). 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. FDA 510(k) is not FDA approval or FDA certification of the medical device, it is only a marketing clearance. FDA does not provide approval or certification through 510 k process nor issue a certificate of registration, but you will get a 510 k number.
Please note that FDA does not perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after FDA 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (QSR) inspection at any time after FDA 510(k) clearance.
FDA does not specify who must apply for a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require FDA 510(k) submission.
The following four categories of parties must submit FDA 510(k):
Domestic manufacturers introducing a device to the U.S. market;
Finished device manufacturers must submit FDA 510(k) if they manufacture a device according to their own specifications and market it in the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices. However, manufacturers of device components are not required to submit a 510(k) unless such components are promoted for sale to an end user as replacement parts. Contract manufacturers, those firms that manufacture devices under contract according to someone else's specifications, are not required to submit FDA 510(k).
Specification developers introducing a device to the U.S. market;
A specification developer develops the specifications for a finished device, but has the device manufactured under contract by another firm or entity. The specification developer submits the FDA 510(k) Notification, not the contract manufacturer.
Repackers or relabelers who make labeling changes or whose operations significantly affect the device.
Repackagers or relabelers may require FDA 510(k) Submission if they significantly change the labeling or otherwise affect any condition of the device. Significant labeling changes may include modification of manuals, such as adding a new intended use, deleting or adding warnings, contraindications, etc. Operations, such as sterilization, could alter the condition of the device. However, most repackagers or relabelers are not required to submit a 510(k).
Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market also require FDA 510 (k) submission
Please note that all manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow design controls during the development of their device. The holder of a 510(k) must have design control documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing processes must be made in accordance with the Quality System regulation (QSR) and may be subject to a new 510(k).
Liberty Management Group can assist you to get FDA 510(K) Clearance (Approval) for your medical device; our experienced consultants can provide you the right guidance in FDA 510 k submission requirements. Our consultant can help you from predicate device selection through establishment registration and listing. LMG provides US Agent service for foreign medical device manufacturers.
Our services includes:
- Identification of device class, product code and regulation number
- Identification of predicate device
- Identification of test standards
- Identification of 510k test requirements
- Identification testing or certification lab
- medical device label review
- Preparation of 510k documents
- Submission of 510k document to FDA
- Provide US Agent service for 510 k
- Communicate to FDA on behalf of our client
- Prepare clarifications to questions from FDA
- Assistance in transfer of 510k review fees to FDA
- Notify the new 510 k number
- Assistance in Establishment registration with FDA
- Assistance in Device Listing with FDA
Sections included in FDA 510(K) submission, Please note there is no 510(k) form.
- FDA Medical Device User Fee Cover Sheet
- FDA Premarket Review Submission Cover Sheet
- FDA 510(k) Cover Letter
- FDA 510(k) Indications for Use Statement
- FDA 510(k) Summary or FDA 510(k) Statement
- FDA Truthful and Accuracy Statement
- FDA Class III Summary and Certification
- Financial Certification or Disclosure Statement
- Declarations of FDA Conformity and Summary Reports
- FDA 510 (k) Executive Summary
- Medical Device Description
- FDA 510(k) Substantial Equivalence Discussion
- Proposed Labeling
- Sterilization and Shelf Life
- Electromagnetic Compatibility and Electrical Safety
- Performance Testing-Bench
- Performance Testing-Animal
- Performance Testing-Clinical
In a Traditional or Abbreviated 510(k), FDA recommends that you include the sections headings listed, preferably in the sequence below. In some instances, the information in a particular section may not apply to your device. In order to speed reviews, FDA recommend you retain the section headings in the sequence listed.
Medical Device User Fee Cover Sheet.
The Medical Device User Fee Cover Sheet and receipt of the user fee payment, allow FDA to begin processing your submission; therefore, you should provide a Medical Device User Fee Cover Sheet with your 510(k) submission .
CDRH Premarket Review Submission Cover Sheet.
The CDRH Premarket Review Submission Cover Sheet is a voluntary form used to help provide basic administrative information for all types of premarket notification submissions.
510(k) Cover Letter.
FDA recommend that you include a 510(k) Cover Letter with your submission .
Indications for Use Statement.
FDA recommend that you use this section to provide the indications for use statement, which is a document where you identify and describe the specific indications for use statement for the device(s) included in the 510(k) submission.
Your indications for use statement should be exactly the same as the indications for use
listed throughout the rest of your 510(k) submission, including the indications for use in
the device labeling .
510(k) Summary or 510(k) Statement.
Each 510(k) submission must include either a 510(k) Summary or 510(k) Statement FDA recommend that you use Section 5 to provide the 510(k) Summary or 510(k) Statement. A 510(k) Summary provides a brief summary of the device included in the 510(k) and the supporting information. A 510(k) Statement is a certification that the 510(k) holder will provide a copy of the 510(k) submission, with certain exclusions.
Truthful and Accuracy Statement.
All 510(k)s must include a statement certifying that all information submitted in the 510(k) is truthful and accurate and that no material fact has been omitted. The submitter should sign and date the statement .
Class III Summary and Certification.
If your 510(k) is for a device type classified into class III for which FDA have not called for PMAs, it must contain a Class III Summary and Certification. The Class III Summary and Certification provide a review of the risks and adverse events known and associated with the general category of devices into which the proposed device falls .
Financial Certification or Disclosure Statement.
If you submit information from clinical studies, you must submit a financial certification and/or a disclosure statement for each clinical investigator who participated in your study .
Declarations of Conformity and Summary Reports.
If your 510(k) is an Abbreviated 510(k) submission, FDA recommends that you use this section to provide the information regarding any declarations of conformity to a standard or a summary report recommended in any relevant device-specific guidance .
In this section of your 510(k), FDA recommend that you provide an executive summary of the 510(k), which should include a .
- concise description of the device, including the indications for use and technology
- device comparison table
- concise summary for any performance testing in the submission
FDA recommend that you describe the performance specifications and include a brief description of the device design requirements in this section. FDA also recommend that you identify all models, as well as all accessories or components, included in the submission. If diagrams, dimensions, tolerances, and/or schematics are useful to fully describe and characterize the device, FDA recommend that you include them for each device, accessory or component included in the 510(k) submission. FDA also recommend that you provide a list of all patient contacting components and their respective materials .
Substantial Equivalence Discussion.
In the substantial equivalence section, FDA recommends that you identify the predicate you provide a detailed comparison between your device and the predicate sufficient to demonstrate the substantial equivalence of the devices .
The 510(k) must include proposed labeling in sufficient detail. Generally, the term "labeling" includes the device label, instructions for use, and any patient labeling .
Sterilization and Shelf Life.
For devices sold as sterile, FDA recommends that you follow the FDA guidance. For a submission that identifies a shelf life for the device, your shelf life should be supported by appropriate bench tests and/or sterilization (packaging) validation .
If your device contains components that come into direct or indirect contact with patients, you should evaluate the biocompatibility of the patient-contacting materials .
This section should include the appropriate software documentation as described in the FDA guidance .
Electromagnetic Compatibility and Electrical Safety.
If your device design includes an electronic component, FDA recommend that you evaluate its electromagnetic compatibility (EMC). EMC encompasses both emissions (interference with electronic products) and immunity (interference with device performance created by emissions from other electronic products) .
If you submit bench test results to support substantial equivalence, FDA recommend you include the following information in this section.You should describe the bench testing and provide the results that support the performance characteristics of your device. Generally, all submissions should include the information below .
- list the specific bench tests conducted
- describe each test protocol
- summarize the results
- describe your analysis
- discuss your conclusions
If you conducted animal testing, FDA recommends that you describe the tests and provide the results that support the performance characteristics of your device. Generally, all submissions that describe animal testing should include the information below; however, if a relevant device-specific guidance is available, you should follow the recommendations in that guidance document .
- list the specific animal tests conducted
- describe each test protocol
- summarize the results
- describe your analysis
- discuss your conclusions
If your submission describes clinical studies, FDA recommend that you provide the clinical protocol that identifies the: .
- objective of the test
- test methods and procedures (including any specific test conditions)
- study endpoints (usually both safety and effectiveness)
- statistical methodology used
P.S. The above information's gathered from FDA Guidance documents. the information's may be changed, for updated information's please visit www.fda.gov .