U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. Premarket Notification 510(k)
  7. 510(k) Submission Process
  1. Premarket Notification 510(k)

510(k) Submission Process

Send Medical Device eSTAR and eCopy Premarket Submissions Online

October 3, 2022 - The FDA is announcing that you may now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal ("CDRH Portal").

Building on the progress tracker for 510(k) submissions launched in 2021 and the trial process of electronic uploads launched in July 2022, the CDRH Portal now allows anyone to register for a CDRH Portal account to send CDRH eCopy or eSTAR premarket submissions online.

Starting October 1, 2023, all 510(k) submissions, unless exempted (as described in Section VI.A of the final guidance, Electronic Submission Template for Medical Device 510(k) Submissions), must be submitted as electronic submissions using eSTAR.

Acknowledgement of Receipt

You can send an eSTAR or eCopy to submit your 510(k).

After you submit your 510(k) to the FDA, and when the FDA receives the 510(k) submission, it assigns the submission a unique control number. This number is commonly referred to as the "510(k) number," or "K number." The 510(k) number begins with the letter "K" followed by 6 digits. The first two digits designate the calendar year the submission was received; the last four digits represent the submission number for the year, starting with 0001 and increasing with each new submission.

For example: the first 510(k) submission for calendar year 2022 is K220001.

The FDA then conducts two verification checks to confirm that:

  1. The proper user fee payment was received for the submission.
    Note: the user fee amount to be paid is based on when the 510(k) is received by the FDA and not the date on which it was sent by the submitter.
  2. A valid eSTAR or eCopy of the 510(k) submission was provided.

If the proper user fee has not been paid and/or a valid eSTAR or eCopy has not been provided, then the FDA will email a Hold Letter to the 510(k) submitter, usually within 7 days of receipt of the 510(k). The submitter then has 180 calendar days from the date of the Hold Letter to fully resolve the issues with the user fee or submission. If the issues are not resolved within 180 days, then the 510(k) is considered to be withdrawn and deleted from our review system, and the submitter will need to submit a new, complete 510(k) to pursue FDA marketing clearance.

If the proper user fee has been paid AND a valid eSTAR or eCopy has been provided, the FDA will email an Acknowledgment Letter to the contact person identified in the 510(k) submission. The Acknowledgement Letter identifies:

  • the date of receipt (this is the date that FDA received the 510(k) submission, the proper user fee payment, and valid eSTAR or eCopy); and
  • the 510(k) number assigned to the submission.

Note: The Acknowledgment Letter is NOT a marketing clearance letter. The 510(k) number identified 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 delays.

Format and Submission Acceptance Review

For eSTAR, given that an electronic submission properly prepared with an electronic submission template should represent a complete submission, eSTAR submissions are not anticipated to undergo a refuse to accept (RTA) process. However, FDA intends to employ a virus scanning and technical screening process for an eSTAR.

If the eSTAR submission is not complete when submitted, FDA will notify the submitter by email and identify the incomplete information, and the 510(k) will be placed and remain on hold until a complete replacement eSTAR is submitted to the FDA. If a replacement eSTAR is not received within 180 days of the date of technical screening deficiency notification, the FDA will consider the 510(k) to be withdrawn and the submission will be closed in the system. 

For more information, see Electronic Submission Template for Medical Device 510(k) Submissions.

For eCopy, the Lead Reviewer conducts the Acceptance Review using the appropriate Acceptance Checklist in FDA's Guidance titled Refuse to Accept Policy for 510(k)s.

After the Acknowledgement Letter is sent, the FDA routes the 510(k) to the appropriate OHT, based on the device type and medical specialty that is listed in the 510(k) submission.

Upon receipt in the Office, the 510(k) is assigned to the appropriate Division, and then assigned to a Lead Reviewer.

In the Acceptance Review, the Lead Reviewer determines whether the 510(k) submission meets the minimum threshold of acceptability and should be accepted for substantive review.

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).

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.

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. If this is not done, the 510(k) is considered withdrawn and deleted from our review system. If the 510(k) is deleted, the 510(k) submitter will need to submit a new, complete 510(k) to pursue FDA marketing clearance for that device.

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

Substantive Review (including Substantive Interaction and Interactive 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.

Interactive Review

If the Lead Reviewer chooses to continue with an Interactive Review, this means the Lead Reviewer has determined that any outstanding deficiencies may be adequately addressed within the Medical Device User Fee Amendment (MDUFA) timeframe and that the submission will not be placed on hold. The Lead Reviewer communicates with the submitter during the Interactive Review using tools such as:

  • Email
  • Telephone Call

During Interactive Review, the Lead Reviewer may request additional information from the submitter, who may either send the information to the Lead Reviewer directly or to the FDA. Note: During Interactive Review, any information submitted to the FDA must include a valid eSTAR or eCopy.

Additional Information (AI) Request

If 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. Note: The FDA must receive a complete response within 180 calendar days of the date of the AI Request. No extensions beyond 180 days are granted. If FDA does not receive a complete response to all deficiencies in the AI Request within 180 days of the date of the AI Request, the submission will be considered withdrawn and deleted from our review system. If the 510(k) is deleted, the 510(k) submitter will need to submit a new 510(k) to pursue FDA marketing clearance for that device.
The submitter must submit the response, with a valid eSTAR or eCopy, to the FDA. The response should include:

  • submitter's name;
  • 510(k) number;
  • identification of the submission as Additional Information (AI) to the 510(k);
  • date of the FDA's request for additional information; and
  • the requested information in an organized manner.

For more information on Substantive Review, or Interactive Review, as well as suggested responses to deficiencies, please see the FDA's Guidances:

510(k) Decision Letter

The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days. FDA Days are calculated as the number of calendar days between the date the 510(k) was received and the date of a MDUFA decision, excluding the days the submission was on hold for an AI request. MDUFA Decisions for 510(k) submissions include findings of substantially equivalent (SE) or not substantially equivalent (NSE).

When a decision is made,the 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." The FDA adds the cleared 510(k) to the 510(k) database weekly. The Indications for Use (IFU) and the 510(k) Summary or 510(k) Statement will be included as attachments to the SE letter. The IFU and the 510(k) Summary or Statement make up a SE package. Complete SE packages are posted monthly. The IFU will not be signed since it is considered an attachment to the SE letter. Therefore, the signature on the SE letter will apply to both the letter and the IFU.

If the FDA does not reach a MDUFA decision within 100 FDA days (that is, 10 days after the MDUFA goal), the 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 the FDA from reaching a final decision, with an estimated date of completion.

For each of the critical decision points in the decision-making process the FDA uses to determine substantial equivalence, see the guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].

Timeline of Communication with 510(k) Submitters

The FDA follows the MDUFA performance goals for review of 510(k) submissions.

When you submit a 510(k) submission to CDRH for review, your official correspondent can monitor the FDA's progress online in a simple, concise format. For more information, see Send and Track Medical Device Premarket Submissions Online: CDRH Portal.

References

 

Back to Top