Contains Nonbinding Recommendations  
FDA and Industry Actions on  
De Novo  Classification  Requests: 
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  October 2,  2017.  
 
This document supersedes  FDA and Industry Actions on  De  Novo 
Classification  Requests:  Effect on FDA Review Clock and  Goals   
issued October  5, 2021.  
 
 
 
For questions about this document regarding CDRH-regulated devices  contact the Office of  
Regulatory Programs/Division of Submission Support/Premarket Notification (510(k)) Staff  at  
301-796-5640, or by email at  OPEQSubmissionSupport@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 & DRUG 
Food and Drug Administration  
ADMINISTRATION 
Center for Devices and Radiological Health  
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-2017-D-5712.  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  16058  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 ....................................................................................................................  1  
II.   Scope ..............................................................................................................................  2  
III.   FDA Actions  ..................................................................................................................  2  
A.   Issue an Order Granting the Request to Classify the Device .........................................  3  
B.   Issue an Order Declining the Request ............................................................................  3  
C.   Request for Additional  Information ...............................................................................  5  
D.   Issue a Notice of Withdrawal .........................................................................................  5  
IV.   De Novo Performance Goals for MDUFA  IV ...............................................................  6  
V.   De Novo Performance Goals for MDUFA V  ................................................................  7  
A.   Submission .....................................................................................................................  7  
B.   Acceptance Review ........................................................................................................  8  
C.   Substantive Review ........................................................................................................  9  
D.   MDUFA V Goals ...........................................................................................................  9  
E.   Missed MDUFA Decision Communication.................................................................  10  
VI.   Requester Actions  ........................................................................................................  10  
A.   Response to an AI Request  ..........................................................................................  10  
B.   Request for Withdrawal  of the De Novo Request  .......................................................  11  
  Contains Nonbinding Recommendations  
FDA and Industry Actions on  
De Novo  Classification  Requests: 
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 De 
Novo  classification  requests (De Novo  requests). 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 De  Novo requests  
received  in  FY  2023-2027.  These  performance goals are outlined in the MDUFA V 
Commitment Letter from the Secretary of Health and Human Services (the Secretary)  to  
Congress2  and are further  described below.  
 
 
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.  
  1  Contains Nonbinding Recommendations  
On  October 5, 2021, FDA issued a final rule on the De  Novo Classification Process.3   This  
final rule added  new regulations at 21 CFR Part 860, Subpart D--De Novo  Classification that 
describe the procedures and criteria  FDA uses  in assessing whether a  request for an 
evaluation of automatic  class III designation (De  Novo classification request or De Novo 
request) contains the information necessary to permit a substantive review.    
 
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 
use of the word should  in Agency guidances means that something is suggested or  
recommended, but not required.  
II.   Scope  
 
This document describes:  
 
   the different FDA actions that may be taken on De Novo  requests;  
 
   the effect each action has  on goals under MDUFA IV for De Novo requests received 
in FY 2018-2022;  
 
   the effect each action has on goals under MDUFA V for  De Novo  requests received  
in FY  2023-2027; and  
 
   the different industry actions that may be taken on De Novo  requests.  
III.   FDA Actions  
 
FDA will begin substantive review of a De Novo request after the request is accepted under  
21 CFR 860.230. After  FDA conducts  a  substantive review  of the submission, FDA may  take 
any of the following actions  (21 CFR  Part  860,  Subpart D):  
 
   issue an order granting a  De Novo  request for  classification (granting order);  
 
   issue an order declining a  De Novo  request for  classification (decline  order);  or  
 
   issue a request  for additional information (AI  request).  
 
Further, in accordance with 21 CFR  860.250(a), the Agency may consider  a  De Novo  request  
to be withdrawn if additional information is not provided within 180 calendar  days following 
issuance of  an  AI  request. In this instance, FDA may issue a notice of  withdrawal  to the  
requester  (21 CFR 860.250(b)).  A notice of withdrawal is sometimes referred to as a 
 
3  Medical Device De Novo Classification Process (86 FR 54826) at https://www.federalregister.gov/d/2021-
21677  
  2  Contains Nonbinding Recommendations  
deletion letter. The term deletion is used to differentiate a lack of timely response (under 
21 CFR 860.250(a)(1)-(2)) from a  request to withdraw a pending De Novo request by the  
requester  (21 CFR 860.250(a)(4)).  
 
Of these  FDA actions, issuing a granting order,  issuing a  decline  order, and withdrawing a  
De Novo request  are considered MDUFA decisions, as defined in the MDUFA V  
Commitment Letter.   
 
The following sections describe the  actions FDA  may take on an accepted  De Novo  request, 
explain when these  actions may be appropriate, and discuss the effect that  each action has on 
the review  clock.  
A.   Issue an Order  Granting the Request to  Classify the  
Device  
 
An order  granting the  De Novo request to classify  the device (granting order) is a letter  
issued to the  De Novo  requester  stating that FDA  has  determined  that the device meets the  
criteria for classification  into either  class I or  class II.4  A granting order  authorizes marketing  
of the device in  the  United States (U.S.), subject to specific statutory and regulatory 
requirements.   
 
The criteria for granting  a De Novo  request are described in section 513(f)(2) of the FD&C  
Act  and 21 CFR  Part  860. The  grounds  on which FDA  may decline a De Novo request are  
described  in 21 CFR 860.260.   If none of the reasons apply, then FDA  will issue an order  
granting a De  Novo request. Such an order  shuts off the review clock, marks the end of FDA  
review, and is  considered a final action.  
B.   Issue an  Order  Declining  the Request  
 
An order  declining  the De Novo  request (decline  order) is a letter issued to a De Novo  
requester  (21 CFR 860.260(b))  stating that FDA has determined that  either: a) the device is  
not eligible for De Novo  classification; or b)  the device is eligible for De Novo  classification,  
but  the requester has not  demonstrated that the  device described in the  De Novo  request  
meets the criteria under section 513(a)(1) of the  FD&C Act and 21 CFR 860.260. Therefore, 
the request is declined  and  the device remains in class III (Premarket Approval).  
 
FDA  will  issue a decline  order  in the following situations  (21 CFR 860.260(c)):  
 
   the device does not meet  the criteria under section 513(a)(1) of the  FD&C  Act and  21 
CFR  860.3 for classification into class I or  II  (21 CFR 860.260(c)(1));  
 
   the De Novo request contains a false statement of  material fact or there is a material  
omission  (21 CFR 860.260(c)(2));  
 
4  See section 513(f)(2)  of the FD&C Act.  
  3  Contains Nonbinding Recommendations  
 
   the devicess labeling does not comply with the requirements in 21 CFR  parts 801 or  
809, as applicable  (21 CFR 860.260(c)(3));  
 
   the product  does not meet the definition of a device under section 201(h) of the  
FD&C  Act  and is not a combination product as defined at  21 CFR  3.2(e)  (21 CFR 
860.260(c)(4));  
 
   the device is of  a type which has already been approved in existing applications for  
PMAs  (21 CFR 860.260(c)(5));  
 
   the device  is of  a type  which has already been classified  into class I,  class  II, or  class  
III  (e.g., it is probable that the device could be determined to be substantially 
equivalent (SE) to a predicate device (i.e.,  a device that has already been classified  
within an existing class I  or class  II  classification regulation or an unclassified 
preamendments device))  (21 CFR 860.260(c)(6));  
 
   an inspection of a relevant facility under 21 CFR  860.240(c) results in a  
determination that general or general and special controls would not provide  
reasonable assurance of safety and effectiveness  (21 CFR 860.260(c)(7));   
 
   a  nonclinical study subject to 21 CFR  part 58 that is described in the De  Novo 
request, and that is essential to show there is reasonable assurance of safety, was not  
conducted in compliance with 21 CFR  part 58 and no reason for the noncompliance is  
provided or, if a  reason is provided, the practices used in conducting the study do not  
support the validity of the study  (21 CFR 860.260(c)(8));  
 
   a  clinical investigation described in the De Novo request involving human subjects  
that is subject to the institutional review board  regulations in  21 CFR  part 56, 
informed consent regulations in  21 CFR  part 50, or  good clinical practice (GCP)  
described in 21 CFR  812.28(a), was not conducted in compliance with those  
regulations such that the  rights or safety of human subjects were not adequately 
protected or the supporting data were determined to be otherwise unreliable  (21 CFR  
860.260(c)(9));  
 
   a clinical or nonclinical study necessary to demonstrate that general controls or  
general  and special controls provide reasonable assurance of safety and effectiveness:  
(i) has not been completed per the study protocol, or  (ii) deficiencies related to the 
investigation and identified in any request for additional information under  21 CFR 
860.240(b)(1) have not been adequately addressed  (21 CFR 860.260(c)(10)); or  
 
   After the De Novo request is  accepted for review  under 21 CFR 860.230(b), the  
requester makes significant unsolicited changes to the devices  indications for use or  
technological characteristics  (21 CFR 860.260(c)(11)).  
 
  4  Contains Nonbinding Recommendations  
FDAs decision  to decline a De Novo request  will be based on review of the totality of  the 
information provided to support the De Novo request, and may  therefore be  a combination of  
multiple  issues outlined above.  A  device that is  eligible for De Novo  classification  will be 
declined if  the totality of  the  information provided, including performance  data, is  
insufficient (e.g., data that  were inadequate or inconclusive) to demonstrate  that  the device is  
of low to moderate risk. A  De Novo request  will also  be declined if,  based on  the totality of  
the information provided, including performance  data, FDA determines that  general controls  
would be  inadequate to control the risks  and special controls to mitigate the risks cannot be  
developed.   
 
A decline  order  will inform the requester of the deficiencies in the De Novo  request, 
including each applicable ground for declining  (21 CFR 860.260(d)). A decline order  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  De Novo  request lacks  
information necessary for the Agency to complete  its  review and determine whether to grant  
or decline the De Novo  request  (21 CFR 860.240(b)(1)). AI requests  are  issued by  email with  
an attachment document identifying deficiencies.5  These requests  inform the  requester  that 
the De Novo  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  requester 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. Any additional information submitted to FDA must include the reference number  
assigned to the original De Novo request  and, if submitted on the requesters own initiative, 
the reason for submitting the additional information (21 CFR 860.240(b)(2)).  
D.   Issue a Notice of Withdrawal  
 
A notice of withdrawal informs the  De Novo  requester  that FDA considers  the  De Novo  
request  to be withdrawn. The notice of withdrawal represents an FDA decision to discontinue  
its review of the  De Novo  request.  
 
In accordance with 21 CFR 860.250(a), FDA considers  a De Novo  request  to have been  
withdrawn if:  
 
5  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.  
 
  5  Contains Nonbinding Recommendations  
 
   FDA does not receive a complete response  in a submission  to  a request for  additional  
information  pursuant to 21 CFR 860.240(b)(1)  within 180 calendar  days  after  the date 
FDA issues such request  (21 CFR 860.250(a)(1));   
 
   FDA does not receive  a response,  after refusing to accept the De Novo request  or a 
technical screening  hold,  within 180  calendar  days of the date notification was issued 
by FDA  (21 CFR 860.250(a)(2));  
 
   FDA is not permitted  an opportunity to inspect  relevant  facilities, pursuant to 21 CFR  
860.240(c), at  a reasonable time and in a reasonable manner, and to have access to 
copy and verify all records pertinent to the De Novo request  (21 CFR 860.250(a)(3)); 
or  
 
   The requester submits a written notice to FDA that the De Novo  request has been  
withdrawn  (21 CFR 860.250(a)(4)).  
 
If a De Novo request 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 shuts off the  
review clock, marks the  end of FDA review, and is considered a final action. The notice will 
include the De Novo request reference number  and the date FDA considered the De Novo 
request withdrawn  (21 CFR  860.250(b)).  
IV.   De Novo Performance Goals for MDUFA IV  
 
The performance goals for  De Novo  requests received from FY 2018  through FY 2022  (the 
time frame defined for MDUFA  IV) were  defined in the MDUFA  IV  Commitment Letter.6  
Performance goals and  associated changes  that were  implemented in MDUFA IV  include:  
 
   most  De Novo  requests  became subject to user fees;  
 
   FDA issued  draft and  final guidance that includes  a submission checklist to facilitate  
a more efficient and timely review process;  
 
   De Novo  requests  became subject to a one-tier MDUFA decision goal (there are no  
cycle (or  review  cycle) goals for interim actions);  and  
 
   for De Novo requests for which a MDUFA decision has not been rendered within 180  
FDA  days,7  at the requesters request and resources permitting, but not to the  
detriment of meeting the  quantitative review timelines, FDA will discuss with the  
 
6  Available at https://www.fda.gov/media/102699/download.  
7  As described in  Section VII.D of the MDUFA IV Commitment Letter and  Section VIII.C  of the MDUFA V 
Commitment Letter, FDA Days are those calendar days when a submission is considered to be under  review at  
the Agency  for submissions that have been accepted. See Section VIII.C  of the MDUFA V Commitment Letter,  
available at  https://www.fda.gov/media/158308/download.  
  6  Contains Nonbinding Recommendations  
requester  all outstanding issues with the submission preventing FDA from reaching a  
decision.  
V.   De Novo  Performance Goals for MDUFA  V  
 
The performance goals for  De Novo  requests received from FY 2023  through FY 2027  (the 
time frame defined for MDUFA  V) are  defined in the MDUFA  V  Commitment Letter.8  Most  
of the performance goals  and associated changes included in Section IV of  this guidance are  
also retained in MDUFA  V. To fulfill the submission checklist requirement,  FDA issued a 
final guidance  document  Acceptance Review  for  De Novo Classification  Requests9  in 
2019, and updated the guidance in 2021  in conjunction  with  the issuance of a final rule for 
the De Novo classification process,10  which took effect on January 5, 2022.  
 
Relative to MDUFA IV,  the only significant change in MDUFA V are the performance goals  
for De Novo requests. De Novo request performance goals will increase for FY 2026 and FY  
2027  if performance goals for FY 2023 and FY 2024 are met, respectively, as outlined in the  
MDUFA goals section  below.  
A.   Submission  
 
Most  De Novo  requests will be subject to a user fee as described in the guidance  document  
entitled  User  Fees and Refunds for  De Novo  Classification  Requests,11  and all  De Novo  
requests  will be subject to the requirement for an eCopy  or an electronic submission 
(eSubmission) using an electronic submission template (e.g., eSTAR (electronic Submission 
Template And  Resource)).12,13,14  FDA is  authorized by section 745A(b)(1) of the FD&C Act   
to implement eCopy requirements for De Novo requests  after the issuance of final guidance  
and is authorized by section 745A(b)(3)  of the  FD&C Act to implement requirements for  
submissions solely in electronic format. Please see the guidance  entitled  eCopy Program for  
Medical Device Submissions,15  for more information about eCopy requirements  and the  
guidance  entitled Providing Regulatory Submissions for Medical Devices  in Electronic  
 
8  https://www.fda.gov/media/158308/download  
9  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-
classification-requests   
10  Medical Device De Novo Classification Process (86 FR 54826) at https://www.federalregister.gov/d/2021-
21677  
11  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-and-refunds-de-novo-
classification-requests   
12  See FDAs website regarding the eSTAR program, available at  https://www.fda.gov/medical-devices/how-
study-and-market-your-device/voluntary-estar-program.  This website provides current information regarding  
the  eSTAR program  for CDRH and CBER.  
13  eSTAR is the only type of electronic submission template that is currently available to facilitate the  
preparation of De Novo requests as eSubmissions. For simplicity, the electronic submission created with this  
electronic submission template is often referred to as an eSTAR.  
14  https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-
electronic-and-paper-format-cber-regulated-products   
15  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions  
  7  Contains Nonbinding Recommendations  
Format   Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic  
Act16  for more information about eSubmission  requirements.  
 
De Novo  requests will not be processed and distributed to the appropriate  Office  for review  
without confirmation of user fee payment  (or applicability of a user fee exception),  and a 
valid eCopy  or eSTAR.  
B.   Acceptance Review  
 
In accordance with  21 CFR 860.230, within 15 calendar days of receipt, FDA  intends to  
conduct an acceptance review  to make a threshold determination that the De Novo request  
contains the information necessary to permit a  substantive review.17  If  FDA refuses to accept  
a De Novo request,  FDA  will notify the  requester  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, Acceptance Review for  De Novo Classification Requests.18  
 
This communication represents an administrative  review of the submission and is not  
indicative of deficiencies that may be identified later in the review cycle.  
 
When submitting an eSTAR,  the RTA  requirements of 21 CFR 860.230,  have  been  
automated within the eSTAR.19  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  De Novo  eSTAR. FDA intends to begin 
the technical screening  for De Novo  electronic submissions  after confirmation of  user fee 
payment.  After  receipt, FDA may seek to verify that the submission type is  correct during the  
technical screening period. If this initial verification  reveals that the submission is  an  
incorrect type (e.g., a De  Novo  was received  for a device  type already approved  as a PMA),  
FDA will  place the submission on hold in order to allow for withdrawal of  the submission, if 
appropriate.  If the eSTAR  does not pass the technical screening  process  due to an inaccurate 
response or  at least one obviously irrelevant attachment, FDA will notify the submitter via  
email20  and identify the  inaccurate or irrelevant  information, and the  De Novo  will be placed  
 
16  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-
submissions-medical-devices-electronic-format-submissions-under-section-745ab   
17  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 De Novo requester.  
18  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-
classification-requests    
19  For more information on the  RTA process, please see Acceptance Review for De Novo  Classification 
Requests, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/acceptance-review-de-novo-classification-requests.  
20  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.  
  8  Contains Nonbinding Recommendations  
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 files 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  acceptance  or technical  
screening  phase of  review), FDA  will conduct  a  substantive review  (21 CFR 860.240(a)). 
During the substantive review,  FDA will  generally  communicate with the  requester  through 
a Substantive Interaction. The Substantive Interaction communication can be  an AI  request  
(which stops the clock)  or an email stating that FDA will attempt  to resolve any outstanding 
deficiencies  interactively  in real-time, without stopping the review clock  (Interactive 
Review).   
 
Following a Substantive Interaction, FDA intends  to work with the  requester  via Interactive 
Review to reach a MDUFA decision.  
D.   MDUFA V  Goals  
 
MDUFA V  includes  a goal  for a MDUFA decision (see Table 1  below), defined in terms of  
FDA Days,  which are 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  (i.e., user fee is paid and a valid eCopy or eSTAR  is  provided).  
 
Table 1. De Novo  Performance Goals  
 
Review Time  
Action   Fiscal Year   Performance Level  
(FDA days)  
FY 2023   70%  
FY 2024   70%  
MDUFA  FY 2025   70%  
Decision   70%  
150   FY 2026  
(grant/decline/   (80% if FY 2023 goal is met)21  
withdraw)   70%  
FY 2027   (80%  if FY 2023 goal is met/  
90%  if FY 2024 goal is met)22  
 
 
21  The goal will be adjusted if the conditions of Section III.B of the MDUFA V Commitment Letter are met. For  
additional information, see Section III.B of the MDUFA V Commitment Letter, available  at 
https://www.fda.gov/media/158308/download.  
22  The goal will be adjusted if the conditions of Section III.B of the MDUFA V Commitment Letter are met. For  
additional information, see Section III.B of the MDUFA V Commitment Letter, available  at 
https://www.fda.gov/media/158308/download.  
  9  Contains Nonbinding Recommendations  
E.   Missed MDUFA  Decision Communication  
 
At Industrys request and as resources permit, but not to the detriment of meeting the  
quantitative review timelines, if a final decision has not been rendered within 180 FDA  days, 
FDA will discuss with the  requester, in a meeting or teleconference,  all outstanding issues  
with the submission preventing FDA from reaching a decision. This discussion will reflect  
appropriate management input and  approval, and will include action items for FDA and/or  
the requester, as appropriate, with an estimated date of completion for  each  party to complete 
their respective tasks.  
VI.   Requester  Actions  
 
Actions taken by the  requester  of a pending De Novo  request  may include  submission of a  
response to FDAs AI request (i.e., not a request  made via interactive review) or withdrawal  
of the  De Novo request  (either by submission of a request for  withdrawal  or by not  
responding to an FDA AI request  within  180 calendar  days)  (see 21 CFR 860.250(a)). The 
information below describes the actions a  requester may take and the effect  each  action has  
on the review  clock.  
 
As with  the original  De Novo  request, any amendment or supplement to a  De Novo  request  
or a request to withdraw a De Novo  request  will need  to be submitted via  eCopy or eSTAR  
for the submission to be processed as described  in the guidance documents  eCopy Program 
for Medical Device Submissions23  and Providing Regulatory Submissions for Medical  
Devices in Electronic Format   Submissions Under Section 745A(b) of the Federal  Food, 
Drug, and Cosmetic Act.24  
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  De Novo  request  (21 CFR 860.240(b)).  
 
The requester 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 requesters submission of a response to an AI request is an action that, upon receipt by 
FDA,  resumes the review clock  (i.e.,  the 150-day review clock  resumes upon receipt of the 
additional information).  
 
 
23  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions    
24  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-
submissions-medical-devices-electronic-format-submissions-under-section-745ab   
  10   Contains Nonbinding Recommendations  
If FDA determines that the  requester  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 requester  by 
email  that the response is incomplete and  the De  Novo request will be placed back on hold as  
of the date of the original AI request;  therefore,  the review  clock has  not resumed. The 
requester  will have 180 calendar  days from the date of the original  AI  request in which to 
submit a complete response, or the  De Novo  request  will be considered to be withdrawn  (21 
CFR 860.250(a)(1)).  
B.   Request for  Withdrawal of the De Novo  Request  
 
A request to withdraw a  De Novo  request  informs FDA of the  requesters intent to  
discontinue its pursuit of FDA review of the  De Novo  request  (21 CFR 860.250(a)(4)).  
 
The De Novo  requester  may request withdrawal  of the pending De Novo  request  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  a pending De Novo  request  shuts off the review clock, marks the  
end of FDA review, and is considered a final action. If the  De Novo  request  is under review  
at the time FDA receives the withdrawal request, the review  clock  will  stop on that date. If  
the De Novo  request  is on hold at the time FDA receives the  withdrawal request, the review  
clock  will  remain stopped as of the date the  De Novo  request  was last placed on hold.  
  11