Continuing with our latest newsletter on 510(k), this time we will explain in more details about the content of traditional 510(k) and its submission process.

I. 510(k) Elements:

 

Element 1: General information

This part consists of a Medical Device User Fee Cover Sheet and CDRH Premarket Review Submission Cover Sheet. Both of them can be found on FDA’s website.

 

Element 2: Table of contents

The table of contents should list each required item with page numbers, including a list of attachments and appendices. 

 

Element 3: 510(k) Acceptance Checklist

The 510(k) Acceptance Checklist is used to determine whether the 510(k) meets a minimum threshold of acceptability and should be accepted for substantive review. 

Element 4: Statement of Indications for use

The statement should include specific indications, clinical settings, define the target population, anatomical sites, etc. This statement must be consistent with the labeling, advertising, and instructions for use. Once the review is complete, FDA will include the Indications for Use Statement with the Substantial Equivalence (SE) letter to the applicant and make it available to the public on the Internet.

 

Element 5: 510(k) Summary or Statement

Prepare either a 510(k) Summary or a 510(k) Statement. A 510(k) Summary is a summary of information upon which manufacturers based their claim of substantial equivalence. The 510(k) Statement is a certification that the 510(k) owner will provide safety and effectiveness information supporting the FDA finding of substantial equivalence to ANY person within 30 days of a written request. The choice between the 510(k) Summary and 510(k) Statement should be made before the 510(k) is submitted.

 

Element 6: Truthful and Accurate Statement

The statement may be included in the 510(k) Cover Letter or on a separate page identified in the table of contents. If the CDRH Premarket Review Submission Cover Sheet is used, the statement should be attached as a separate page.

 

Element 7: Proposed Labeling

This is a labeling section including copies of all proposed labels, labeling, package inserts, service manuals, instructions for use, advertising, and/or promotional materials. 

Element 8: Specifications

This section should include both a narrative description of the device and a physical or technical description.

The narrative description of the “new” device should include the indications for use, principles of operation, power source, composition, and other information necessary to understand the device. 

The physical description of the “new” device may include labeled diagrams, photographs or pictures, engineering drawings, schematics, etc. These may include all internal and external, assembled and unassembled, interchangeable, etc., parts of the device and should address their name and function. In addition, the description should include the length, width, height, diameter, weight, etc., of the device and identify any parts which are intended for single use.

 

Element 9: Substantial Equivalence Comparison

Manufacturers should include a comparison table AND discussion of the similarities and differences of their device compared to one or more predicate devices to which they are claiming equivalency.

 

Element 10: Performance

Most 510(k)s will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. The data may include test results from engineering, bench, design verification, human factors, and animal testing, and clinical studies and clinical trials. Tests should be conducted on all sizes and models of the device in a manner as similar as possible to how the device will be used. The results of testing and methodology/parameters used for testing should be included.

 

II, Submission Process and Timeline:

 

Step 0: Submit device user fee before sending the application

Send a printed copy of the Medical Device User Fee Cover Sheet with the device user fee. 

Step 1: Log-in and Acknowledgement Procedure

A 510(k) submitter should submit one electronic copy or eCopy of its 510(k) to CDRH’s or CBER’s Document Control Center (DCC). If the proper user fee has been paid AND a valid eCopy has been provided, the DCC will email an Acknowledgement Letter to the contact person identified in the 510(k) submission.

 

Step 2: Acceptance Review

Upon receipt in the Office, the 510(k) is assigned to the appropriate Division, and then assigned to a Lead Reviewer.  The Lead Reviewer conducts the Acceptance Review using the appropriate Acceptance Checklist in FDA’s Guidance. Within 15 days of the receipt of the submission, the submitter will receive an electronic notification of the Acceptance Review result, which will:

• identify the name and contact information of the FDA Lead Reviewer assigned to the 510(k); and
• indicate the status of the 510(k).

 

A 510(k) not accepted for review is placed on RTA Hold.  The submitter has 180 calendar days to fully address the deficiencies cited in the RTA Hold.

Once accepted, a 510(k) proceeds to the Substantive Review.

Step 3: Substantive Review

During Substantive Review, the Lead Reviewer conducts a comprehensive review of the 510(k) submission and communicates with the submitter through a Substantive Interaction, which should occur within 60 calendar days of receipt of the 510(k) submission.

The Substantive Interaction communication is typically:

• an email stating that FDA will proceed to resolve any outstanding deficiencies via Interactive Review; or
• an Additional Information (AI) request which places the submission on hold.

 

Step 4: 510(k) Decision Letter

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. 

A 510(k) that receives an SE decision is considered “cleared.” FDA adds the cleared 510(k) to the 510(k) database, which is updated weekly. 

If FDA does not reach a decision within 100 FDA days, FDA will issue a Missed MDUFA Communication, which is written feedback to the submitter to be discussed in a meeting or teleconference, including the major outstanding review topic areas or other reasons that are preventing FDA from reaching a final decision, with an estimated date of completion.

 

In summary, 510(k) is a very comprehensive and helpful process which encourages each business in the medical field to never stop innovating their operation and enhancing products’ quality. NobleNetwork is always willing to support businesses interested in the US market and 510(k) application. Please do not hesitate to contact us for support and information!