Contains Nonbinding Recommendations  
 
 
FDA and Industry Actions on 
Premarket Notification (510(k)) 
Submissions:  Effect on FDA  Review  
Clock and Goals  
 
Guidance  for Industry and  
Food and Drug Administration Staff   
 
Document  issued on  October 3, 2022.  
 
Document originally issued  on May 21, 2004.  
 
This document supersedes FDA and Industry Actions on  Premarket  
Notification (510(k)) Submissions: Effect on FDA Review Clock and  Goals  
issued October 2, 2017.  
 
 
 
For questions about this document regarding CDRH-regulated devices,  contact the Office of  
Regulatory Programs/Division of Submission Support/510(k), De Novo, 513(g), Device  
Determinations and Custom Devices Lifecycle Team at (301) 796-5640, or by email to 
510k_program@fda.hhs.gov. For questions about  this document regarding CBER-regulated  
devices, contact the Office of Communication, Outreach, and Development  (OCOD) at 1-
800-835-4709 or 240-402-8010, or by email at  ocod@fda.hhs.gov.  
 
 
U.S.Department of Health and Human Services  
Food and Drug Administration  
U.S. FOOD & DRUG 
Center for Devices and Radiological Health  
- ADMINISTRATION  Center  for Biologics Evaluation and Research  
 
 
 
 
  Contains Nonbinding Recommendations  
 
   
Preface  
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration 
to https://www.regulations.gov. Submit written comments to the Dockets Management  Staff, 
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD  
20852-1740. Identify all  comments with the docket number  FDA-2003-D-0033.  Comments  
may not be acted upon by the Agency until the document is next revised or updated. 
 
 
 
Additional Copies  
CDRH  
Additional copies are  available from the  Internet. You may also send an email request to  
CDRH-Guidance@fda.hhs.gov  to receive a copy  of the guidance.  Please include  the 
document number  1219 and complete title of  the guidance in the  request.  
 
CBER  
Additional copies are  available from the Center  for Biologics Evaluation and Research 
(CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New  
Hampshire Ave., WO71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-
835-4709 or 240-402-8010, by email, ocod@fda.hhs.gov, or from the  Internet at   
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances. 
   
  Contains Nonbinding Recommendations  
Table of Contents  
 
I.   Introduction  .................................................................................................................  4  
II.   Scope  ...........................................................................................................................  5  
III.   FDA Actions ................................................................................................................  5  
A.   Issue an Order Declaring a Device SE .................................................................  6  
B.   Issue an Order Declaring a Device NSE  ..............................................................  7  
C.   Request for Additional  Information  .....................................................................  7  
D.   Advise the Submitter that the 510(k) is Not Required .........................................  8  
1.   Not-a-Device Decision .........................................................................................  8  
2.   Exempt from 510(k) Decision ..............................................................................  8  
E.   Issue a Notice of Withdrawal ...................................................................................  9  
IV.   510(k) Performance Goals for MDUFA  IV  ................................................................  9  
V.   510(k) Performance Goals for MDUFA V ................................................................  10  
A.   Submission  .........................................................................................................  11  
B.   Acceptance Review ............................................................................................  11  
C.   Substantive Review   ...........................................................................................  12  
D.   MDUFA V Goals  ...............................................................................................  12  
E.   Missed MDUFA Decision Communication...........................................................  13  
VI.   Submitter Actions ......................................................................................................  13  
A.   Response to an AI Request  ................................................................................  14  
B.   Request for Withdrawal  of the 510(k) Submission ............................................  14  
C.   Extensions of Time to Respond to an AI Request  .............................................  15  
 
  Contains Nonbinding Recommendations  
FDA and Industry Actions on 
Premarket Notification (510(k)) 
Submissions:  Effect on FDA  Review  
Clock and Goals  
 
 
Guidance  for Industry and  
Food and Drug Administration Staff   
 
This guidance represents the current thinking of the Food and Drug Administration  (FDA  
or Agency) on this topic.  It does not  establish  any rights for any person and is  not binding 
on  FDA or the public.  You can use an alternative approach if  it  satisfies the requirements  
of the applicable statutes and regulations.  To discuss an alternative approach, contact the  
FDA staff or Office responsible for this guidance  as  listed on the title page.   
I.   Introduction  
The Medical Device User Fee Amendments of 20221  (MDUFA  V)  amended the Federal  
Food, Drug,  and Cosmetic Act (the FD&C  Act) to  authorize FDA to collect user fees for the 
review of  certain premarket submissions  received on or after  October  1, 2022, including 
premarket notification submissions (510(k)s).  The additional funds obtained from user  fees  
will enable FDA, with the cooperation of industry, to improve the device  review process to 
meet  certain  performance goals  and implement improvements for the medical device review  
process.  
 
Performance goals were  negotiated and agreed to under  MDUFA V  for 510(k)s received in 
FY  2023-2027.  These  performance goals and process improvements are outlined in the letter  
from the Secretary of  Health and Human Services  to  Congress2  (MDUFA V  Commitment 
Letter)  and are further described  below.  
 
In general, FDAs guidance documents do not establish legally enforceable  responsibilities. 
Instead, guidances describe the Agencys current thinking on a topic and should be viewed 
only as recommendations, unless specific regulatory or statutory requirements are cited. The  
 
1  See Title II of the FDA  User Fee  Reauthorization Act of  2022  (Public  Law 117-180).  
2  See 168 CONG. REC. S5194-S5203 (daily ed. September 28, 2022)  (Food and Drug Administration User Fee  
Reauthorization).  The MDUFA V Commitment Letter  is  also  available at  
https://www.fda.gov/media/158308/download.  
4  
  Contains Nonbinding Recommendations  
use of the word should  in Agency guidances means that something is suggested or  
recommended, but not required.  
II.   Scope  
This  guidance  document  describes:    
 
   the different FDA actions that may be taken on premarket notifications (510(k)s);  
 
   the effect each action has on goals under  MDUFA IV  for 510(k)s received  in FY  2018-
2022;  
 
   the effect each action has on goals under  MDUFA V for 510(k)s received in FY  2023-
2027;  and  
 
   the different industry actions that may be taken on 510(k)s.  
III.   FDA Actions  
FDA intends to begin substantive review of  a 510(k) after the submission is accepted per the  
refuse to accept (RTA) criteria outlined in the guidance  Refuse to Accept Policy for  
510(k)s,3  or passes the technical screening for  an electronic submission (eSubmission)  
submitted using the electronic Submission Template and Resource (eSTAR).4,5  After receipt,  
FDA may seek to  verify that the submission type is correct during the RTA/technical  
screening period. If  this initial verification reveals  the submission is an incorrect type  (e.g., a  
Special 510(k) should be  converted to a  Traditional 510(k)), FDA will place the submission 
on hold to allow the appropriate submission type to be submitted.   The review clock will  
begin on the date the  correct submission type is received for submissions that pass RTA or  
technical screening review.  After  FDA  conducts a substantive review of the submission,  FDA 
may take any of the following actions (21 CFR 807.100(a)):  
 
   issue an order declaring a device substantially equivalent (SE)  to a legally  marketed  
predicate device (SE letter);  
 
   issue an order declaring a device not substantially equivalent (NSE)  to any legally 
marketed predicate device (NSE letter);  
 
3  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks   
4  See FDAs guidance Electronic Submission Template for  Medical Device 510(k) Submissions,  available at  
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-
medical-device-510k-submissions,  and FDAs website regarding the eSTAR program, available at  
https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program.  The  website  
provides current information regarding  the  eSTAR program  for CDRH and CBER.  
5  eSTAR is the only type of electronic submission template that is currently available to facilitate the  
preparation of  510(k) submissions as eSubmissions. For simplicity,  the electronic submission created with this  
electronic submission template is often referred to as an eSTAR.  
5  
  Contains Nonbinding Recommendations  
 
   issue a request  for  additional information (AI  request);  or  
 
   advise the submitter that the 510(k) submission is not required (i.e., the  product is not  
regulated as  a device or the device is exempt from the premarket notification  
requirements of the FD&C  Act).  
 
Further, in accordance with 21 CFR 807.87(m), the  Agency  may consider  a 510(k) to be  
withdrawn if additional information is not provided within 30 days following issuance of  an  
AI request.  In this instance, FDA may issue a notice of withdrawal.   A  notice of withdrawal  
is sometimes referred to  as a deletion letter.  The term deletion is used  to differentiate a 
withdrawal under 21 CFR 807.87(m) from a request to withdraw a pending 510(k) by the  
submitter.  Please note that FDAs current policy is to allow a  submitter  180  calendar  days to 
respond to an  AI request.  See Section III.E Issue a Notice of Withdrawal  for more details.  
 
Of these  FDA actions, issuing an SE letter and issuing an NSE letter are considered MDUFA  
decisions, as defined in the  MDUFA IV6  and MDUFA V7  Commitment Letters.  
 
The following sections describe the  actions FDA  may take on an accepted  510(k), explain 
when these actions may be appropriate, and discuss the effect that each action has on the  
review clock.  
A.   Issue an Order Declaring a Device SE  
An order declaring  a device  to be SE  (SE letter) is a letter  issued  to the 510(k) submitter  
stating  that FDA has determined that the device described in the 510(k) submission is  
substantially equivalent to a legally marketed device.8   An order declaring a  device to be SE  
authorizes marketing of the device in the  United States (U.S.), subject to specific statutory 
and regulatory requirements.   
 
The criteria for determining a device to be SE are described in  section 513(i) of the  FD&C  
Act and in 21 CFR 807.100(b).  Additional information relating to determinations of SE can 
be found in the guidance  documents entitled The  510(k) Program: Evaluating Substantial  
Equivalence in Premarket Notifications [510(k)],9  and Determination of  Intended Use for  
510(k) Devices; Guidance for CDRH Staff  (Update to K98-1).10  
 
An SE decision shuts off  the review  clock,  marks the end of  FDA review, and is considered a  
final action.  
 
6  See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 2017)  (Food and Drug Administration User Fee  
Reauthorization).  The MDUFA IV Commitment Letter is also available at  
https://www.fda.gov/media/102699/download.  
7  https://www.fda.gov/media/158308/download  
8  See 21 CFR 807.92(a)(3) for  the definition  of legally marketed device.  
9  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-
substantial-equivalence-premarket-notifications-510k   
10  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/determination-intended-use-
510k-devices-guidance-cdrh-staff-update-k98-1  
6  
  Contains Nonbinding Recommendations  
B.   Issue an Order Declaring a Device NSE  
An order declaring  a device to be NSE  (NSE letter)  is a letter issued to a 510(k) submitter  
stating  that FDA has determined that the device described in the 510(k) submission is  not  
substantially equivalent  to any  legally marketed device and may not be introduced into 
commercial distribution in the U.S.  
 
In general, FDA issues an NSE letter in the following situations:  
 
   no predicate device exists;  
 
   the device has a new intended use compared to the  identified  predicate device;  
 
   the device has different technological characteristics that raise different questions of  
safety and  effectiveness than the identified predicate device; or  
 
   the device has new indications for use or different technological characteristics than 
the identified  predicate device,  and required performance data was not provided to 
allow FDA to reach a substantial equivalence determination.   This may include  
inadequate or inconclusive  performance data (e.g.,  bench testing, clinical data, or  
animal data).  
 
An NSE decision  shuts off  the review clock,  marks the end of FDA review, and is considered 
a final action.  
C.   Request  for  Additional Information  
FDA issues a  request for  additional information  (AI request)  when the 510(k) submission 
lacks  the  information necessary for the  Agency  to complete  its  review and  to determine  
whether the device is SE  or NSE  (21 CFR 807.87).  AI requests are  issued by  email with an  
attached  document  identifying deficiencies.11   These requests  inform the submitter that the  
510(k) is being placed on hold pending receipt of  a  complete response to all of the identified 
deficiencies.   The hold starts on the issue date of the AI  request.  
 
FDA generally issues an AI request when  FDA believes the additional information needed 
from the submitter is not suitable for interactive review and/or cannot be provided within a  
reasonable timeframe  (i.e., such that the review would be unduly delayed if the submission 
were not placed on hold).    
 
An AI request  is an interim action that stops  the review clock and marks the end of an FDA  
review cycle.   The review clock will resume  upon the receipt of a complete response to the 
AI request.  
 
11  Please note that AI requests from CBER will be  issued according  to,  SOPP 8119: Use of  Email for  
Regulatory Communications,  available at  https://www.fda.gov/media/108992/download.  
7  
  Contains Nonbinding Recommendations  
D.   Advise the Submitter that  the 510(k) is Not Required  
It is  the manufacturers  responsibility to determine whether  a 510(k) submission is required 
based on the  FD&C  Act,  medical  device  regulations, and FDA-issued guidance documents.  
The Division of  Industry and Consumer Education (DICE), the  510(k), De  Novo, 513(g), 
Device Determinations and Custom Devices Lifecycle Team,  the review division, and 
product classification resources on the  CDRH Device Advice website, available at  
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm,  can assist  
manufacturers  in ascertaining whether a device is  exempt by regulation.12  Manufacturers  may  
also obtain information regarding the regulatory status of a device or product by submitting a  
513(g) request.   For  further information on 513(g)  requests, please refer to the guidance  
document entitled FDA  and Industry Procedures  for Section 513(g) Requests for  
Information under the Federal Food, Drug, and Cosmetic  Act.13  
  
1.   Not-a-Device Decision  
A not-a-device letter informs the submitter that the product described in the 510(k) is not  
regulated as  a device.   FDA should issue  a not-a-device letter when FDA has determined  
that the product described in the 510(k) submission does not meet the definition of device  
in section 201(h)  of the  FD&C  Act.  
 
The issuance of a not-a-device letter  shuts  off  the review  clock, marks the  end of  FDA  
review, and is  considered a final action.  
2.   Exempt from 510(k) Decision  
An exempt letter informs the 510(k) submitter that the device described in the 510(k)  
submission is classified as exempt from the premarket notification requirements of  section  
510(k) of the  FD&C  Act.   FDA will issue  an exempt letter, or  otherwise advise the 
submitter,  when FDA determines that the device described in the 510(k) submission is  
exempt by regulation from the premarket notification requirements of  section 510(k) of the  
FD&C  Act.   Exemptions  are found in 21 CFR 807.20(c), 807.65,  and 807.85, as well as  
individual classification regulations (21 CFR Parts 862-892).  
 
The issuance of an exempt letter  shuts  off  the review clock, marks the end of FDA  review, 
and is considered  a final  action.  
 
12  For CBER submissions, please  contact  the Office  of Communication, Outreach, and Development, the review  
division, and  the product classification resources on the CDRH Device Advice website, available at  
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.  
13  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-
section-513g-requests-information-under-federal-food-drug-and-cosmetic  
8  
  Contains Nonbinding Recommendations  
E.   Issue a Notice of  Withdrawal  
A notice of withdrawal informs the 510(k) submitter that FDA considers the  510(k)  
submission to be withdrawn (21 CFR 807.87(m)).   The notice of withdrawal represents  an 
FDA decision to discontinue its review of the 510(k) submission because the submitter failed  
to submit a timely and complete response to an  AI request that placed the submission on 
hold.  
 
In accordance with 21 CFR 807.87(m), FDA may consider a 510(k) to be  withdrawn if the  
submitter fails to provide a complete response to an AI request within 30 days of that request.  
In the past, FDA has not  strictly enforced this time  frame and has  allowed  submitters  
additional time to respond to AI  requests.   
 
FDA intends to continue  this practice of  allowing additional time, not to exceed 180  calendar  
days  from the date FDA issues the AI request, to submit a complete response.  FDA 
considers  a 510(k) submission to be withdrawn if  FDA does not receive a  complete response  
in a submission  to all of the deficiencies in the AI  request within 180  calendar  days of the  
date of that AI  request.   Therefore, submitters are not  required to submit written requests for  
extension  from 30 calendar days to 180 calendar days.  
 
If a  510(k) submission is  withdrawn while the submission is on hold, an FDA notice  of 
withdrawal  does not affect the review  clock.   Issuance of  a  notice  of withdrawal stops the  
review clock,  marks the end of FDA review,  and is considered a final action.  
IV.   510(k) Performance Goals  for MDUFA  IV  
The performance goals for 510(k) submissions received from FY  2018  through FY  2022  (the 
time frame defined for MDUFA  IV) were defined  in  the MDUFA IV  Commitment Letter.14   
Table 1  below summarizes the performance goals  for 510(k) submissions, where 510(k)  
decisions include SE and NSE, and all review times are in  FDA  calendar days.  Performance 
goals are  applied to the  MDUFA  IV  cohort of 510(k) submissions and include  goals for  
Substantive  Interaction,  MDUFA decision, and Total Time  to Decision.  
 
The goals for  Substantive Interaction  and MDUFA decisions  are in terms of FDA  Days,  
which are defined in the MDUFA  IV  Commitment Letter as those calendar days when a 
submission is considered to be under review at the Agency for submissions that have been 
accepted.  FDA Days begin on the date of receipt  of the submission or the amendment to the  
submission that enables the  submission to be accepted.  
 
Total Time to Decision  was a shared outcome goal  for which FDA  and industry performance  
were  reported during MDUFA  IV.  FDA and submitters shared  responsibility for this goal, 
which was intended to achieve an objective of a  reduced average total time to a MDUFA  
decision (SE or NSE).  This goal measures the total time to decision which includes the time  
 
14  https://www.fda.gov/media/102699/download  
9  
  Contains Nonbinding Recommendations  
spent by FDA reviewing the application as well as the time spent by the applicant responding 
to questions from FDA.   
 
The Total  Time to Decision is the number of calendar days from the date of receipt of  an 
accepted submission to a MDUFA decision. As defined in the MDUFA  IV  Commitment 
Letter,  the average Total  Time to Decision for 510(k) submissions  was  calculated as the 
trimmed mean of Total Times to Decision for 510(k) submissions within a closed cohort, 
excluding the highest 2% and the lowest 2% of values.  A cohort is considered to be closed 
when 99% of the  accepted submissions have reached a MDUFA decision.  
 
Table 1. 510(k) Performance Goals  Under MDUFA IV  
 
Review  
Performance Level (by FY)  
Time  
Action  
(FDA 
FY2018   FY2019   FY2020   FY2021   FY2022  
days)  
Substantive  
60   95%   95%   95%   95%   95%  
Interaction  
MDUFA Decision  
90   95%   95%   95%   95%   95%  
(SE/NSE)  
 
Total Time in  Calendar Days  
Average Total Time to  
  124   120   116   112   108  
Decision  
V.   510(k) Performance Goals  for  MDUFA V  
The performance goals for  510(k) submissions  received  from FY  2023 through FY  2027 
(MDUFA V) are defined  in the MDUFA  V Commitment Letter.15   Performance goals and  
associated changes introduced under MDUFA  III, MDUFA IV,  and retained in MDUFA V  
include:  
   most 510(k)  submissions are subject to a user fee, and all  510(k)  submissions need a  
valid eCopy16  or electronic submission17  in order to initiate  a review;  
   510(k) submissions are subject to an Acceptance  Review prior to being considered for  
substantive review;18  
 
15  https://www.fda.gov/media/158308/download  
16  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions  
17  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-
submissions-medical-devices-electronic-format-submissions-under-section-745ab   
18  Given that an electronic submission properly prepared with an electronic submission template should 
represent a complete submission, eSTAR submissions are not anticipated to undergo an RTA process. See  
Section V.B. for additional details.  
10  
  Contains Nonbinding Recommendations  
   510(k) submissions are subject to a  Substantive Interaction (SI) Goal;  
 
   510(k) submissions are subject to a one-tier MDUFA decision goal  (for FDA Days  
and Total Time to Decision);  and  
 
   for 510(k)s for which the MDUFA decision is exceeded by 10  calendar  days, FDA 
will send a  Missed MDUFA  Decision  (MMD)  communication to the submitter.  
Performance goals and associated changes introduced under MDUFA V include:  
   revised  goals for Substantive Interaction, MDUFA decision, and Total Time to 
Decision (see Table 2  below).    
A.   Submission  
Most 510(k) submissions will be subject to a user  fee  as described in the guidance User Fees  
and Refunds  for Premarket Notification Submissions (510(k)s)19  and all 510(k)s will be  
subject  to the requirement for an eCopy or an electronic submission  using eSTAR.  Please  see 
the guidance  entitled eCopy Program for Medical Device Submissions,20  for more  
information about eCopy requirements and the guidance  entitled Electronic Submission 
Template for Medical Device 510(k) Submissions21  for more information about eSTAR  
requirements  for 510(k) submissions. 510(k)  submissions will not be processed and 
distributed to the appropriate Division for review  without confirmation of user fee payment  
(or applicability of a user fee exception),  and a valid eCopy  or eSTAR.  
B.   Acceptance Review  
Within 15 calendar days  of receipt, FDA  will conduct an Acceptance Review to determine 
whether  the submission is complete and can be accepted for substantive review.22   If FDA 
refuses to accept a 510(k), FDA  will  notify the submitter  within 15 calendar days  that the  
submission has not been accepted. The notification will  identify  those items  that are the basis  
for the refuse to accept  (RTA) decision and are therefore necessary for the  submission to be  
considered accepted.  The submission  will be placed on hold and the review clock will not  
start until the  missing  elements are provided.  For additional information, please refer to the  
guidance, Refuse to Accept Policy for 510(k)s.23   
 
19  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-and-refunds-
premarket-notification-submissions-510ks  
20  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions  
21  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-
medical-device-510k-submissions   
22  In the case of a government closure during the  15-day review period, the review  period may be extended by a  
comparable  number of business days that the FDA buildings are closed. If the submitter receives an automated  
notice that the acceptance review was  not completed because the screening period has exceeded 15 calendar  
days, FDA may send a correction notice to the submitter.  
23  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks  
11  
  Contains Nonbinding Recommendations  
 
This communication represents a  preliminary review of the submission and is not indicative  
of deficiencies that may  be identified later in the review cycle.  
 
Given that an electronic submission properly prepared with an electronic submission template  
should represent  a complete  submission,24  eSTAR submissions are not anticipated to undergo 
an  RTA process.25  However, FDA intends to employ a virus scanning and technical  
screening process for an  eSTAR.  The technical screening process is anticipated to occur  
within 15 calendar  days of FDA  receiving the 510(k) eSTAR. FDA intends to only begin the  
technical screening for 510(k) electronic submissions where the  appropriate user fee has been 
paid. If the eSTAR is not complete when submitted, FDA will notify the submitter via  
email26  and identify the incomplete information, and the 510(k) will be placed and remain on 
hold until a complete replacement eSTAR is  submitted to FDA.  The technical screening  
review time does not impact the review clock  for  submissions  that pass the technical  
screening. For  a submission that passes technical screening, the  review clock starts on the day 
the submission was received by FDA.  
C.   Substantive Review  
Once the submission has  been accepted for review (i.e., after the RTA  or technical  screening  
phase of review), FDA  will conduct the substantive review. During the substantive review, 
FDA will generally  communicate with the submitter through a Substantive Interaction within  
60 calendar days of  receipt of the accepted 510(k) submission.  The Substantive Interaction 
communication can be  an AI request or an email stating that FDA will continue to resolve  
any outstanding deficiencies via  Interactive Review.  An SE letter issued prior to the  
Substantive Interaction goal date will also qualify as a Substantive  Interaction for purposes of  
meeting the  MDUFA V  goal.  
 
Following a Substantive Interaction, FDA intends  to work with the submitter via  Interactive  
Review to  reach a MDUFA decision.   
D.   MDUFA V Goals  
MDUFA V includes goals for Substantive  Interaction, MDUFA decision, and Total Time to 
Decision (see Table 2  below).  
 
 
 
 
 
24  After a submitter completes all necessary sections in their eSTAR file correctly, the status message at the top  
of the PDF will indicate eSTAR Complete to represent  a complete  submission.  
25  For more information  on the RTA process, please see Refuse to Accept Policy for 510(k)s available at  
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks.  
26  For additional information about email communications with CBER, please see the SOPP 8119: Use of  
Email for Regulatory Communications, available at https://www.fda.gov/media/108992/download.  
12  
  Contains Nonbinding Recommendations  
Table 2. 510(k) Performance Goals  Under MDUFA V  
Review  
Performance Level (by FY)  
Time  
Action  
FY202 
(FDA 
FY2023   FY2024   FY2025   FY2026  
7  
days)  
Substantive  
60   95%   95%   95%   95%   95%  
Interaction  
MDUFA Decision  
90   95%   95%   95%   95%   95%  
(SE/NSE)  
 
Total Time in Calendar  Days  
Average Total Time to   112   112  
  128   124   112  
Decision   (108)27   (108)28  
 
Note  that the methods by which goals for Substantive Interaction  and  MDUFA decision  are 
assessed have  not changed from MDUFA  IV.  
E.   Missed MDUFA Decision Communication  
For all 510(k)s that do not reach a MDUFA decision within 100 FDA  days  (i.e., 10 calendar  
days after the MDUFA goal), FDA  will  provide  a  missed MDUFA decision 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  as well as an  estimated date of completion.   
VI.   Submitter  Actions  
Actions  taken by the submitter of a pending 510(k) may include submission of  a response to 
FDAs  AI request  (i.e., not a request made via Interactive Review)  or withdrawal of the  entire 
510(k)  submission  (either by request  or by not  responding to an FDA AI request  within 180  
calendar  days).  The information below describes  the actions a submitter may take and the 
effect each action has on the review  clock.    
 
As with the original 510(k) submission, any submission of additional information to a 510(k)  
will need to include an eCopy or eSTAR as part of the submission for the submission to be  
 
27  The goal will be adjusted if the conditions of Section III.A  of the MDUFA V Commitment Letter are met. For  
additional information, see Section III.A  of the MDUFA V Commitment Letter, available  at 
https://www.fda.gov/media/158308/download.  
28  The goal will be  adjusted if the conditions of Section III.A  of the MDUFA V Commitment Letter are met. For  
additional information, see Section III.A  of the MDUFA V Commitment Letter, available  at 
https://www.fda.gov/media/158308/download.  
13  
  Contains Nonbinding Recommendations  
processed.29  
A.   Response to an AI Request  
A response to an FDA  AI  request  is the submission of additional information, addressing  all  
of the  deficiencies  identified in that AI  request, that allows FDA to continue or complete the  
substantive review and reach  a decision on the 510(k)  submission.  
 
The submitter should provide a complete response to an  AI request  from  FDA.  The response  
should address all of the deficiencies identified by  FDA  in its  AI request  to be considered a  
complete response.  
 
The submitters  submission of a response to an  AI request  is an action that, upon receipt by 
FDA,  resumes  the review clock  (i.e., the  90-day review  clock  resumes  upon receipt of the  
additional information).  
 
If FDA determines that the submitter has not addressed one or more of the  deficiencies  
identified in the AI  request, the review cycle will be terminated until FDA  receives a 
response addressing the remaining deficiencies.   In such a case, FDA informs  the submitter  
by email that the response is incomplete and  the 510(k) will be placed back on hold as of the  
date of the original  AI request;  therefore, the review  clock has not  resumed.  The submitter  
will have 180  calendar  days from the date of  the  original AI request in which to submit a  
complete response,  or the  entire 510(k)  will be considered to be withdrawn  (21 CFR  
807.87(m)).  
 
If the submitter submits  unsolicited additional  information (i.e., not  prompted  by the FDA)  
that constitutes a new indication for use or  a new  or different  technology, the submitter  will 
be  required to submit a new 510(k)  and the associated fee.   This is because  the unsolicited 
information would essentially require  FDA to restart the  substantive review.   
B.   Request  for  Withdrawal of the 510(k)  Submission  
A request to withdraw an entire  510(k) informs  FDA  of the submitters intent to discontinue  
its pursuit of FDA review of the  510(k) submission.   
 
The 510(k) submitter may request withdrawal of the  entire pending 510(k)  submission at any  
time, and for any reason, after it is submitted for review,  but before FDA renders its final 
decision.   FDA does not consider requests for withdrawal after  a final decision has been 
rendered.  
 
The request to withdraw  an entire  pending 510(k)  submission  shuts off  the review clock, 
marks the end of  FDA  review, and is  considered a final action.  If the 510(k) is under review  
 
29  https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-
electronic-and-paper-format-cber-regulated-products   
14  
  Contains Nonbinding Recommendations  
at the time FDA receives  the withdrawal request, the review  clock  will  stop on that date.  If  
the 510(k) is on hold at the time FDA  receives the withdrawal request, the review clock will 
remain stopped as of the  date the 510(k)  was last  placed on hold.   
C.   Extensions of Time to Respond to  an AI Request   
In accordance with 21 CFR 807.87(m), FDA may consider a 510(k) to be  withdrawn if the  
submitter fails to provide additional information within 30 days  of a request.  As explained  
above  in Section III.E, FDA generally permits submitters additional time to respond to such 
requests.  
 
FDA intends to automatically grant a maximum of 180 calendar  days  from the date of the AI  
request, even if the submitter has not requested an extension.  Therefore, submitters are no 
longer required to submit written requests for extension.   
 
However, submitters should be aware that FDA intends  to issue a notice of  withdrawal under  
21 CFR 807.87(m)  if FDA does not receive a complete response in a submission  to all of the  
deficiencies in the AI request within 180 calendar  days of the date that  FDA issued that  AI 
request.  
15