510(k) Submission Process
Premarket Notification (510(k)) submissions for medical devices are reviewed by FDA’s Center for Devices and Radiological Health (CDRH), specifically, the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological Health (OIR). The Divisions in these offices are organized according to medical device specialties. 510(k) submissions are reviewed by ODE and OIR staff, including biomedical engineers, physicians, microbiologists, chemists, and other scientific professionals.
A 510(k) applicant must submit two copies of its 510(k) to CDRH Document Control Center (DCC) to this address:
Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
One of the two copies must be an eCopy.
When the DCC 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 application 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 the year 2013 would be K130001.
The DCC then conducts two verification checks:
- The proper user fee payment was received for the submission.
Note: the correct user fee amount to be paid is based on when the 510(k) is received by FDA and not the date it was sent by the applicant.
- A valid eCopy of the 510(k) submission was provided.
If the proper user fee has not been paid or a valid eCopy has not been provided, then the DCC will email or fax a Hold Letter to the 510(k) applicant, usually within 7 days of receipt of the 510(k). The applicant 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 deleted 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 the valid eCopy has been provided, the DCC will mail and email/fax 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 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 must be referenced in all further correspondence with FDA regarding the 510(k).
After the Acknowledgement Letter is sent, the DCC routes the 510(k) to the appropriate ODE or OIR Division, based on the device classification that is listed in the 510(k) submission.
Upon receipt in the Division, the 510(k) is assigned to the appropriate Branch, and then assigned to a Lead Reviewer. 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.In the Acceptance Review, the Lead Reviewer determines whether a 510(k) submission meets the minimum threshold of acceptability and should be accepted for substantive review. This should be done within 15 calendar days of receipt of the 510(k).
Once complete, 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 status 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 applicant has 180 calendar days to fully address the deficiencies cited in the RTA Hold. If this is not done, the 510(k) is deleted. Once deleted, the 510(k) submitter will need to submit a new, complete 510(k) to pursue FDA marketing clearance for that device.
Upon completion of Acceptance Review, a 510(k) not placed on RTA Hold 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 usually within 60 calendar days of receipt of the 510(k) submission.
The Substantive Interaction communication can be:
- an email stating that FDA will continue to resolve any outstanding deficiencies via Interactive Review; or
- an Additional Information (AI) request which places the file on hold.
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 timeframe set by the Medical Device User Fee Amendment of 2012 (MDUFA III) performance goal for a 510(k) (90 calendar days). The Lead Reviewer communicates with the applicant during the Interactive Review using tools such as:
- Telephone Calls
- Submission Issue Meetings
During the Interactive Review, the Lead Reviewer may request additional information from the applicant, who may either send the information to the Lead Reviewer directly or to the DCC. Note: During Interactive Review, any information submitted to the DCC must include a valid eCopy.
Additional Information (AI) Request
If the Lead Reviewer sends an AI Request, the submission is placed on hold. The applicant has up to 180 calendar days to respond to the AI Request. Note: No extensions beyond 180 days will be granted.
The applicant must submit the response, with a valid eCopy, to the DCC. The response should:
- include the applicant’s name;
- list the 510(k) number;
- identify the submission as Additional Information (AI) to the 510(k);
- list the date of FDA's request for additional information; and
- provide the information in an organized manner.
For more information on Substantive Review and Interactive Review, please see: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals.
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 from the date the 510(k) was received, excluding the days the submission was on hold for an AI request. A MDUFA Decision is a finding of substantial equivalence (SE) or not substantial equivalence (NSE).
When a MDUFA Decision is made, FDA will issue the decision letter to the applicant by mail (and by fax if a fax number was provided).
A 510(k) with 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 MDUFA decision within 100 FDA days, FDA will provide a Missed MDUFA Decision Communication to the applicant in the form of written feedback. This feedback identifies the major outstanding review topic areas or other reasons that prevent FDA from reaching a decision and provide the applicant with an estimated date of completion.
During 510(k) review, FDA follows the MDUFA III performance goals for review and communication of a 510(k) submission. The following diagram provides a simplified summary of event and interaction milestones during the course of a 510(k) submission.
For more information, please see: MDUFA III Performance Goals and Procedures.