FDA 510(k) Clearance Process

Submission

A 510(k) submitter should submit two copies of their 510(k) technical dossier in paper or electronic media (CD, DVD) and eCopy documents to CDRH’s or CBER’s Document Control Center (DCC) at the following address:

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U.S. Food and Drug Administration

Center for Devices and Radiological Health

Document Control Center – WO66-G609

10903 New Hampshire Avenue

Silver Spring, Maryland 20993-0002

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Or

 

U.S. Food and Drug Administration

Center for Biologics Evaluation and Research

Document Control Center

10903 New Hampshire Avenue

WO71, G112

Silver Spring, MD 20993-0002

 

All applicants must submit an eCopy in CD, DVD, or flash drive. All foreign manufacturers are requested to have US Agent for FDA correspondence officially.

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Our FDA 510(k) submission consultants carefully review, analyze, plan, prepare technical dossier for 510(k) submission to ensure the early acceptance of the 510(k) file without RTA or AI and the successful clearance of the 510(k) submission.

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We provide expert advice, predictive device analysis, product code along with regulation number identification, preparation, Identification of testing requirements, US Agent service, Q-Submission and FDA review response services.

 

Acknowledgement or Hold Letter

When the US FDA`s Document Control Center receives the 510(k) submission, it assigns a unique control number to the submission called “510(k) number” or “k" number. The DCC then checks for the receipt of proper fee payment and for a valid eCopy of the 510(k) submission. If the proper user fee has not been paid and/or a valid eCopy has not been provided then the DCC will send a Hold Letter to the 510(k) submitter.

 

The submitter then has 180 calendar days from the date of the Hold Letter to fully resolve the issues with the user fee or eCopy submission. If the issues are not resolved within 180 days, then the 510(k) is considered to be withdrawn and deleted from FDA`s review system, and the submitter will need to submit a fresh updated 510(k) for clearance.

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FDA will email acknowledgement letter or Hold letter to submitter within 7 days of receipt of the 510(k) submission. The acknowledgement letter contains 510(k) number assigned to the submission. The 510(k) number provided in the Acknowledgement letter should be referenced in all further correspondence with FDA regarding the 510(k). Failure to reference the 510(k) number may result in processing delay.

 

Acceptance Review

After sending the Acknowledgement Letter, the DCC routes the 510(k) file to the appropriate ODE or OIR Division based on the device type and medical speciality that is listed in the 510(k) submission. In the division, the file is assigned to an appropriate branch and then to a lead reviewer. The Lead Reviewer conducts the Acceptance Review as per Checklist in FDA’s Guidance titled "Refuse to Accept Policy (RTA)" for 510(k). If the 510(k) submission meets the minimum threshold of acceptability in the application review, the file will be accepted for substantive review.

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Within 15 days of the receipt of the submission, the FDA will electronically notify the results of acceptance review to the submitter. The electronic notification will contain the name and contact information of the FDA Lead reviewer assigned to the 510(k); and indicate the status of the 510(k).

 

The Acceptance Review result will be one of the following:

• the 510(k) was accepted for substantive review; or

• the 510(k) was not accepted for review (i.e., considered refused to accept or RTA); or

• the 510(k) is under substantive review because FDA did not complete the acceptance review within 15 calendar days.

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When a 510(k) not accepted for review and placed on RTA Hold, the submitter has 180 calendar days to fully address the deficiencies cited in the RTA Hold. If the issues are not resolved within 180 calendar days, then the FDA considers 510(k) is withdrawn and it will be deleted from FDAs review system. The submitter will need to submit a fresh, updated 510(k) submission for market clearance.

 

Substantive Review

Once accepted, 510(k) proceeds to the 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. Substantive review should complete within 60 calendar days of receipt of the 510(k) submission.

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Substantive Interaction:

In Substantive interaction, FDA communicates with submitter to resolve the deficiencies observed during the Substantive review. This is done either through Interactive Review or through an Additional Information (AI) request.

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Interactive Review:

When Lead reviewer has determined that any deficiencies observed during the Substantive review may be adequately addressed within the timeframe set by the Medical Device User Fee Amendment of 2012 (MDUFA III) performance goal for a 510(k) (90 FDA days), he chooses to continue with an Interactive Review. The Interactive Review doesn’t place the submission on hold. The Lead Reviewer communicates with the submitter during the Interactive Review via email or telephone. During Interactive Review, the Lead Reviewer may request additional information from the submitter. The submitter may either send the information directly to the Lead Reviewer or to the DCC via a valid eCopy.

 

Additional Information (AI) Request:

When the Lead Reviewer sends an AI Request, the submission is placed on hold. The submitter has 180 calendar days from the date of the AI Request to submit a complete response to the AI Request. If the deficiencies are not resolved within 180 calendar days, then the FDA considers 510(k) is withdrawn and it will be deleted from FDA`s review system. The submitter will need to submit a fresh, updated 510(k) submission for market clearance. The submitter must submit the response with a valid eCopy to the DCC

 

510(k) Decision Letter

The US FDA goal is to make MDUFA Decision for 510(k) submissions. It includes the findings of Substantially Equivalent (SE) or Not Substantially Equivalent (NSE).  When a decision is made, FDA will issue the decision letter to the submitter through the email address provided in the 510(k) cover letter.

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A 510(k) submission that receives a Substantially Equivalent (SE) decision is considered “cleared”. FDA adds the cleared 510(k) to the 510(k) database, which is updated weekly. The IFU and the summary will be sent as attachments to the SE letter.

 

If FDA does not reach a MDUFA decision within 100 FDA days (i.e., 10 days after the MDUFA goal), 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.