Contains Nonbinding Recommendations
De Novo Classification Process 
(Evaluation of Automatic Class III 
Designation)
Guidance for Industry and Food and 
Drug Administration Staff
Document issued on October 5, 2021.
Document originally issued on October 30, 2017.
For questions about this document regarding CDRH-regulated devices, contact the Division 
of Industry and Consumer Education (DICE) at 1-800-638-2041, 301-796-7100, or 
DICE@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
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
OMB Control No. 0910-0844
Current expiration date available at https://www.reginfo.gov.
See additional PRA statement in Section V of this guidance. 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. 
Identify all comments with the docket number FDA-2011-D-0689. 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 
1760 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 20903, 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.  Background ........................................................................................................................... 4
III.  The De Novo Classification Process ................................................................................. 6
A.  When the De Novo Classification Process May and May Not Be Used ..................... 6
B.  Submitting a Pre-Submission for a De Novo Request ................................................ 7
C.  Submitting a De Novo Request for FDA Review ......................................................... 9
D.  Address for De Novo Requests .................................................................................... 10
IV.  FDA Review Process for De Novo Requests .................................................................. 10
A.  510(k) Followed by De Novo Request ......................................................................... 10
B.  De Novo Request  Acceptance Review...................................................................... 10
C.  De Novo Request  Substantive Review ..................................................................... 11
V.  Paperwork Reduction Act of 1995..................................................................................... 13
Attachment 1 ............................................................................................................................... 14
3 Contains Nonbinding Recommendations
De Novo Classification Process 
(Evaluation of Automatic Class III 
Designation)
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 purpose of this document is to provide guidance on the process for the submission and 
review of a De Novo classification request (hereafter a De Novo request) under section 
513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the De 
Novo classification process.  This process provides a pathway to class I or class II classification 
for medical devices for which general controls or general and special controls provide a 
reasonable assurance of safety and effectiveness, but for which there is no legally marketed 
predicate device.  
Throughout this guidance document, the terms we, us and our refer to FDA staff from the 
Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and 
Research (CBER) involved in the review and decision-making aspects of the De Novo 
classification process.  You and your refers to the submitter of a De Novo request and/or 
related materials. 
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law. FDA 
guidance documents, including this guidance, should be viewed only as recommendations, unless 
specific regulatory or statutory requirements are cited.  The use of the word should in Agency 
guidance means that something is suggested or recommended, but not required.
II.  Background
4 Contains Nonbinding Recommendations
A device may be classified in class III and be subject to premarket approval (PMA) via several 
different regulatory vehicles.  In accordance with the criteria at section 513(a)(1)(C) of the 
FD&C Act, FDA may promulgate a regulation classifying, or issue an order reclassifying,1 a 
device type into class III based on the risks posed by the device and the inability of general and 
special controls to provide reasonable assurance of the safety and effectiveness of the device.  
All particular devices of such a type are considered to be in class III and such devices are not 
eligible for the De Novo classification process.
Alternatively, devices of a new type that FDA has not previously classified based on the criteria 
at section 513(a)(1) of the FD&C Act are automatically or statutorily classified into class III 
by operation of section 513(f)(1) of the FD&C Act, regardless of the level of risk they pose or 
the ability of general and special controls to assure safety and effectiveness.  This is because, by 
definition, a new type of device would not be within a type that was on the market before the 
1976 Medical Device Amendments or that has since been classified into class I or class II.  Thus, 
there would be no available predicate device.
This second scenario is what Congress targeted when it enacted section 513(f)(2) of the FD&C 
Act as part of the Food and Drug Administration Modernization Act of 1997 (FDAMA).  The 
process created by this provision, which was referred to in FDAMA as the Evaluation of 
Automatic Class III Designation, will be referred to as the De Novo classification process2
throughout this guidance document.  Congress included this section to limit unnecessary 
expenditure of FDA and industry resources that could occur if devices for which general controls 
or general and special controls provide a reasonable assurance of safety and effectiveness were 
subject to premarket approval under section 515 of the FD&C Act.  Section 513(f)(2) of the 
FD&C Act has allowed manufacturers to submit a De Novo request to FDA for devices 
automatically classified into Class III by operation of section 513(f)(1).  As enacted by 
FDAMA, in order to submit a De Novo request, a device first had to be found not substantially 
equivalent (NSE) to legally-marketed predicate devices through a premarket notification 
(510(k)).  The21st Century Cures Act3 removed a requirement that a De Novo request be 
submitted within 30 days of receiving an NSE determination.4
Section 513(f)(2) was modified by section 607 of FDASIA, which created an alternative 
mechanism for submitting a De Novo request that does not require that a device be reviewed first 
under a 510(k) and found NSE prior to submission of a De Novo request.  If a person believes 
their device is appropriate for classification into Class I or Class II and determines, based on 
1 Prior to the Food and Drug Administration Safety and Innovation Act (FDASIA) enacted in 2012, FDA 
reclassified devices under section 513(e) of the FD&C Act through rulemaking; FDASIA changed this to an order 
process.  
2 The process has been termed De Novo because it requires the agency to evaluate novel devices anew, in 
accordance with the criteria at section 513(a)(1) of the FD&C Act.
3 On December 13, 2016, as part of the 21st Century Cures Act (Pub. L. 114-255), Congress revised  513(f)(2)(i) of 
the FD&C Act.
4 For more information regarding demonstration of substantial equivalence, please see the FDA guidance document 
entitled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], available at 
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/UCM284443.pdf
.
5 Contains Nonbinding Recommendations
currently available information, there is no legally marketed predicate device, they may submit a 
De Novo request without a preceding 510(k) and NSE (hereafter Direct De Novo).    
On October 5, 2021, FDA issued a final rule on the De Novo Classification Process.5 This final 
rule will add new regulations at 21 CFR Part 860, Subpart D--De Novo Classification that 
describe the procedures and criteria FDA will use 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.  FDA is updating this 
guidance to reflect the De Novo final rule. This guidance provides recommendations for 
interactions with FDA related to the De Novo classification process, including what information 
to submit when seeking a path to market via the De Novo classification process.  This guidance 
replaces New Section 513(f)(2)  Evaluation of Automatic Class III Designation, Guidance for 
Industry and CDRH Staff, dated February 19, 1998.  
III.  The De Novo Classification Process
In accordance with section 513(f)(2) of the FD&C Act, you may submit a De Novo request for 
FDA to make a classification determination for the device according to the criteria at section 
513(a)(1) of the FD&C Act.  The De Novo request must include a description of the device and 
detailed information and reasons for any recommended classification (see section 
513(f)(2)(A)(v) of the FD&C Act and 21 CFR 860.220).  FDA must make a classification 
determination for the device that is the subject of the De Novo request by written order within 
120 days of receipt of the request (see section 513(f)(2)(A)(iii) of the FD&C Act and 21 CFR 
860.240).
If the requester demonstrates that the criteria at section 513(a)(1)(A) or (B) of the FD&C Act are 
met, we will grant the De Novo request, in which case the specific device and device type is 
classified in class I or class II.  The granting of the De Novo request allows the device to be 
marketed immediately, creates a classification regulation for devices of this type, and permits the 
device to serve as a predicate device.  We will publish a notice in the Federal Register 
announcing the classification and the controls necessary to provide reasonable assurance of 
safety and effectiveness.  Note that the classification, including any special controls, is effective 
on the date the order letter is issued granting the De Novo request. If the De Novo request is 
declined, the device remains in class III and may not be marketed, unless the device is found 
substantially equivalent to an existing legally marketed class I, class II, or preamendments 
device, the device is reclassified under section 513(f)(3) of the FD&C Act, a PMA is approved, 
or a new De Novo request is granted. 
A.  When the De Novo Classification Process May and May 
Not Be Used
FDA will review De Novo requests for devices that are not within a device type that has been 
classified under the criteria at section 513(a)(1) of the FD&C Act (21 CFR 860.200).  This 
includes devices that do not fall within any existing classification regulation, where the De Novo
5 Medical Device De Novo Classification Process (86 FR 54826) available at 
https://www.federalregister.gov/d/2021-21677 
6 Contains Nonbinding Recommendations
requester either determines that there is no predicate device (21 CFR 860.200(b)(2)) or has 
received an NSE determination on a 510(k) submission (21 CFR 860.200(b)(1)). If the device is 
of a type for which there is an existing classification regulation or one or more approved PMAs, 
the appropriate mechanism for classification into class I or II would be reclassification under 
section 513(e) or section 513(f)(3) of the FD&C Act.6
For devices that have already undergone 510(k) review, FDA will consider a De Novo request if 
the device has been determined to be NSE due to: (1) the lack of an identifiable predicate device, 
(2) a new intended use, or (3) different technological characteristics that raise different questions 
of safety and effectiveness.  Devices that have been found to be NSE due solely to performance 
data that is inadequate to demonstrate substantial equivalence (SE) would generally be ineligible 
for the De Novo classification process.7
In considering whether to submit a De Novo request, the device should appear, based on what is 
known about the device, to meet the statutory standards for classification into class I or class II 
under section 513(a)(1) of the FD&C Act, i.e., general controls or general and special controls 
would provide reasonable assurance of the safety and effectiveness of the device (see 21 CFR 
860.200(a)). Furthermore, you should sufficiently understand and be able to explain all of the 
probable risks to health associated with use of the device that are known or should reasonably be 
known to you and the proposed mitigations, including general controls and, if applicable, special 
controls for each risk8 (21 CFR 860.220(a)(9)).  
B.  Submitting a Pre-Submission for a De Novo Request
A Pre-Submission (Pre-Sub) is not required in order to obtain FDA review of a De Novo request, 
but it is a useful way for requesters to obtain early feedback from FDA and is therefore strongly 
recommended prior to the submission of a De Novo request, especially for devices we have not 
previously reviewed under a 510(k).  A Pre-Sub allows FDA to provide feedback on whether a 
device may be eligible for the De Novo classification process, including whether a potential 
predicate device exists, and/or to advise you on the documentation needed in a subsequent De 
Novo request.  The primary advantage of a Pre-Sub is that it provides an opportunity to obtain 
our preliminary perspective on the likely regulatory controls necessary to provide a reasonable 
assurance of safety and effectiveness, as well as feedback on the evidence, including non-clinical 
and/or clinical data, that will likely be necessary to support the De Novo request.  By obtaining 
this feedback, you can optimize your resources in collecting the safety and effectiveness 
6 See the Agencys Reclassification web page at:  
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/
ucm378724.htm. 
7 For more information regarding demonstration of substantial equivalence, please see The 510(k) Program: 
Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-
notifications-510k).
8 For more information on benefit-risk determinations, please see Factors to Consider When Making Benefit-Risk 
Determinations in Medical Device Premarket Approvals and De Novo Classification 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-when-making-
benefit-risk-determinations-medical-device-premarket-approval-and-de).
7 Contains Nonbinding Recommendations
evidence needed to support a De Novo request, without performing additional unnecessary tests.  
This should also facilitate the review of a subsequent De Novo request.
A Pre-Sub may be submitted early in the development process for a device; however, we believe 
it is most useful after you have identified the proposed intended use and key aspects of the 
device design sufficient to permit a meaningful discussion.  A Pre-Sub related to a future 
anticipated De Novo request should contain sufficient information to enable us to provide 
guidance on the test methods and protocols that should be used for the collection of non-clinical 
and/or clinical data.  De Novo Pre-Subs will be handled in accordance with our normal pre-
submission process.  For information on Pre-Subs, please see the FDA guidance document 
entitled Requests for Feedback on Medical Device Submissions:  The Q-Submission Program 
and Meetings with Food and Drug Administration Staff (Q-Sub Guidance)].9
In addition to the recommended content for all Pre-Subs (device description, proposed intended 
use/indications for use, previous submissions, etc.), we suggest that a Pre-Sub prior to 
submission of a De Novo request also include:
 Proposed class (I or II). Describe why you believe general or general and special controls 
are adequate to provide reasonable assurance of safety and effectiveness. 
 The searches of FDA public databases and other resources, including search terms, used 
to establish that no legally marketed device and no classification regulation for the same 
device type exists.  Provide a list of regulations, 510(k)s, PMAs, and/or product codes 
that may be relevant to the subject device.  You should also provide a rationale for why 
the subject device does not fit within and/or is different from any identified classification 
regulations, 510(k)s, PMAs, and/or product codes, based on available information.  
 Specific questions regarding review issues relevant to a planned De Novo request.  
Insofar as they are necessary in order for us to consider the specific questions, the Pre-
Sub should also include the following:
o  Each identified risk to health associated with the device and the reason for each 
risk (tracing back to risk analysis, clinical testing, etc.).  Briefly describe any 
ongoing and/or planned protocols/studies that need to be completed to collect the 
necessary data to establish the devices risk profile.
o  Information regarding the safety and effectiveness of the device.  Cite the types of 
valid scientific evidence you anticipate providing in your De Novo request, 
including types of data/studies relating to the devices safety and effectiveness.  
Briefly describe any ongoing and/or planned protocols/studies that need to be 
completed to collect the necessary safety and effectiveness data.
o  Protocols for non-clinical and clinical studies (if applicable), including how they 
will address the risks you anticipate and targeted performance levels that will 
demonstrate that general controls or general and special controls are sufficient to 
provide reasonable assurance of safety and effectiveness. 
o  The proposed mitigation measure(s)/control(s) for each risk, based on the best 
available information at the time of the submission.  Highlight which mitigations 
are general controls and which are special controls.  Provide details in the Pre-Sub 
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program.
8 Contains Nonbinding Recommendations
on each recommended mitigation measure (e.g., specific testing required, 
labeling).  
Examples of questions to pose to FDA in a De Novo Pre-Sub include:
 Based on the device description, its intended use/indications for use, and/or technological 
characteristics, and information on the search performed for legally marketed devices, 
does FDA believe the device is eligible for De Novo classification?
 Are there other risks, in addition to those identified in the Pre-Sub, given the indications 
for use for the device?
 If applicable, are there controls that should be considered to provide a reasonable 
assurance of safety and effectiveness for the device?
 Are the non-clinical study protocols sufficient to allow the collection of data from which 
conclusions about device safety and/or effectiveness can be drawn? For example:
o  Is the identified level of concern the appropriate level of concern for the device 
software?10
o  What, if any, additional biocompatibility and/or sterility testing would be 
appropriate?
 If clinical data are needed, are the proposed study design and selected control group 
appropriate? 
After you submit your Pre-Sub, we may ask you for clarification or to provide more information.  
You may also request meetings with us.  For more information on Pre-Subs and meetings with 
FDA staff, please see the Q-Sub Guidance.
C.  Submitting a De Novo Request for FDA Review
A De Novo request may be submitted with or without a preceding 510(k) premarket notification.  
The success of a De Novo request that is filed without a preceding 510(k) or without a Pre-Sub 
will depend more on how well you search for a potential predicate device, identify the risks to 
health and special controls (if applicable), and provide adequate valid scientific evidence to 
support granting the De Novo request.
The De Novo review process is outlined in Attachment 1.  
In preparing to submit a De Novo request, we suggest you review publicly posted information, 
including classification orders, for recently granted CDRH De Novo requests, available on our 
website at https://www.fda.gov/about-fda/cdrh-transparency/evaluation-automatic-class-iii-
designation-de-novo-summaries and 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm or the CBER website 
(see https://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-
information/evaluation-automatic-class-iii-designation-de-novo-summaries-cber).
10 For more information on  software, please see Guidance for the Content of Premarket Submissions for Software 
Contained in Medical Devices (https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-content-premarket-submissions-software-contained-medical-devices)
9 Contains Nonbinding Recommendations
The required content for a De Novo request can be found at 21 CFR 860.220. This includes, for 
example, the devices regulatory history (21 CFR 860.220(a)(3)), indications for use (21 CFR 
860.220(a)(5)), and device description (21 CFR 860.220(a)(6)), among other requirements.  The 
De Novo request should include a discussion demonstrating that the data and information in the 
De Novo request constitute valid scientific evidence within the meaning of  860.7(c) and 
pursuant to  860.7, when subject to general controls, or general and special controls, the 
probable benefit to health from use of the device outweighs any probable injury or illness from 
such use (21 CFR 860.220(a)(14)).  
For De Novo requests, sponsors must submit at least one valid electronic copy (eCopy).  See 
section 745A(b) of the FD&C Act and FDAs eCopy guidance, eCopy Program for Medical 
Device Submissions.11  De Novo requests (and subsequent submissions, as applicable) 
submitted without valid eCopies will be placed on hold and the review clock will not start until a 
valid eCopy is received.  
D.  Address for De Novo Requests 
For devices regulated by CDRH, De Novo requests should be submitted to the current mailing 
address displayed on the website https://www.fda.gov/cdrhsubmissionaddress.  
For devices regulated by CBER, De Novo requests should be submitted to to the current mailing 
address displayed on the website https://www.fda.gov/about-fda/center-biologics-evaluation-
and-research-cber/regulatory-submissions-electronic-and-paper. 
IV.  FDA Review Process for De Novo Requests     
A.  510(k) Followed by De Novo Request
If, at the end of our review of a 510(k), we determine that a device is NSE due to lack of a 
predicate, a new intended use or different types of technology issues, and if we believe general 
controls or general and special controls may provide reasonable assurance of safety and 
effectiveness, we may indicate in the NSE letter that the product may be appropriate for the De 
Novo classification process under section 513(f)(2) of the FD&C Act.  Inclusion of this language 
within an NSE letter does not indicate that sufficient information currently exists within the 
510(k) submission to support a successful De Novo request, but simply indicates that given the 
risk profile of the device, it seems reasonable that De Novo classification may be appropriate.          
B.  De Novo Request  Acceptance Review
Once a De Novo request is received, whether or not it is preceded by a 510(k), 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 (Section IV.C below).  The 
acceptance review process, including the criteria for whether a De Novo request should be 
11 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions 
10 Contains Nonbinding Recommendations
refused or accepted for review, is described in 21 CFR 860.230.  FDA also explains the required 
elements, as well as additional recommendations for preparing your De Novo request, in the 
FDA guidance document Acceptance Review for De Novo Classification Requests.12
If your De Novo request is not accepted for review, the review clock stops and we will notify 
you that it is on hold pending receipt of additional information.  In the event you do not provide 
the requested information within 180 calendar days, we will consider your De Novo request to be 
withdrawn (21 CFR 860.250(a)(2)).  
Within 15 calendar days after a De Novo request is received by FDA, FDA will notify the 
requester whether the De Novo request has been accepted (21 CFR 860.230(a)).  If FDA fails to 
complete the acceptance review within 15 days, FDA will accept the De Novo request for review 
and notify the requester (21 CFR 860.230(b)).
C.  De Novo Request  Substantive Review
After FDA has accepted the De Novo request for review, FDA will begin the substantive review 
of the De Novo request.  As part of FDAs substantive review, FDA intends to conduct a 
classification review of legally marketed device types.  FDA intends to analyze whether an 
existing legally marketed device of the same type exists (e.g., whether your device likely falls 
under an existing class II classification regulation), including whether a predicate was 
established through the De Novo classification process.  If a likely predicate device exists or 
your device falls under a class III classification regulation, your product is not eligible for De 
Novo classification and  your De Novo request will be declined (section 513(f)(2)(A)(iv) and 21 
CFR 860.260(c)(5)-(6)).  FDA will inform you of the deficiencies in your De Novo request, 
including each applicable ground for declining the De Novo request (21 CFR 860.260(d)).  If the 
device falls within a class III classification regulation or there is one or more approved PMAs for 
the same type of device and FDA believes general and/or special controls are adequate to 
provide a reasonable assurance of safety and effectiveness, the appropriate mechanism for 
classification into class I or II would be reclassification under section 513(e) or 513(f)(3) of the 
FD&C Act.  If no existing legally marketed device of the same type is identified, we will 
continue our review.
If the De Novo request is missing information and/or data necessary to determine whether 
general controls or general and special controls can provide reasonable assurance of safety and 
effectiveness, we may issue an additional information (AI) letter or request information via 
interactive review (21 CFR 860.240(b)).  Issuance of an AI letter stops the review clock, and 
once you provide a complete response, the clock will resume and review will continue.  If you 
fail to provide a complete response within 180 calendar days of the date of the AI request, we 
will consider the De Novo request to be withdrawn (21 CFR 860.250(a)(1)).  If a De Novo 
request is withdrawn due to failure to submit adequate information, a new De Novo request is 
required in order to reinitiate review of the device under the De Novo classification process.  
12 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-
novo-classification-requests.
11 Contains Nonbinding Recommendations
A De Novo request may be declined for a number of reasons (21 CFR 860.260(c)).13  If a De 
Novo request is declined, we will issue a written order (21 CFR 860.260(b)) to the requester 
identifying the reasons, including lack of performance data, which warrant declining the De 
Novo request (21 CFR 860.260(d)) and the device remains in class III and may not be legally 
marketed (section 513(f)(2)(B)(ii) of the FD&C Act).  You may either submit an application for 
premarket approval (PMA) under section 515 of the FD&C Act or collect additional information 
to address the issues and submit a new De Novo request that includes the additional information.
FDA will issue to the requester an order granting a De Novo request if none of the reasons in 21 
CFR 860.260(c) for declining the De Novo request applies (21 CFR 860.260(a)).  If a De Novo 
request is granted, we will issue you a written order granting the De Novo request and 
identifying the classification of the device (either class I or class II).  For class II devices, we will 
also identify the special controls.  Effective on the date of the granting order, the requester may 
immediately begin marketing the device subject to the general controls and any identified special 
controls, and the device may be used as a predicate device for future 510(k) submissions as 
appropriate.  
Within 30 days of granting the De Novo request, we will then publish a final order in the Federal 
Register providing public notice of the decision (21 CFR 860.260(a)(2)), which will result in 
codification of the devices identification, classification, and applicable requirements in Title 21 
of the Code of Federal Regulations (device classifications are at parts 862  892). 
A De Novo request for a device that receives marketing authorization via the De Novo 
classification process is referred to as having been granted (similar to PMA approved and 
510(k) cleared). If a De Novo request is granted, we intend to make the written order to the 
submitter granting the De Novo request and a summary of our review of the De Novo request 
available on the CDRH website (see https://www.fda.gov/about-fda/cdrh-
transparency/evaluation-automatic-class-iii-designation-de-novo-summaries and 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm) or the CBER website 
(see https://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-
information/evaluation-automatic-class-iii-designation-de-novo-summaries-cber). Once a De 
Novo request is granted, then the subject device may be used as a predicate for any future 510(k) 
submissions.  Information posted to the FDA website will be redacted to protect any confidential 
commercial, trade secret, or personal privacy information in accordance with 21 CFR Part 20.
We do not anticipate that De Novo requests for the same device type will frequently be under 
review concurrently.  However, in cases where a De Novo request is granted while another 
device of the same type is under review in a separate De Novo request, after the first De Novo 
request is granted, FDA intends to notify the submitter of the other De Novo request still under 
review that a predicate has been established and that the De Novo request still under review will 
be declined.  The submitter of the declined De Novo request may leverage all information in the 
De Novo request by incorporating it by reference in a new 510(k) submission but will still be 
13 Please refer to FDAs guidance FDA and Industry Actions on De Novo Classification Requests: Effect on FDA 
Review Clock and Goals, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/fda-and-industry-actions-de-novo-classification-requests-effect-fda-review-clock-and-goals, for 
additional information.
12 Contains Nonbinding Recommendations
required to demonstrate substantial equivalence in the 510(k) submission, including conformity 
with any newly established special controls for the device type if class II.  
V.  Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520).
The time required to complete this information collection is estimated to average 182 hours per 
response for De Novo requests or 10 minutes per response for requests for withdrawal of a De 
Novo request, including the time to review instructions, search existing data sources, gather the 
data needed, and complete and review the information collection. Send comments regarding this 
burden estimate or suggestions for reducing this burden to:
FDA PRA Staff, 
Office of Operations, 
Food and Drug Administration, 
PRAStaff@fda.hhs.gov 
An agency may not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB control number.  
The OMB control number for this information collection is 0910-0844 (To find the 
current expiration date, search for this OMB control number available at 
https://www.reginfo.gov).
13 Contains Nonbinding Recommendations 
 Attachment 1
De Novo Request Review Process
Pre-Submission
(Optional)
Submission of De Novo 
Request
Refuse De Novo Request placed 
FDA Acceptance Review on hold, requester notified 
of issue(s) to be resolved
Accept
Yes, class III
Decline De Novo Request;  regulation or  Likely predicate, class III  Yes, likely
PMA Required approved PMA regulation or approved  predicate Decline De Novo Request; 
OR Submit 510(k) 
PMA for same device type 
Discuss Reclassification  (unless 510(k) exempt) 
exists?
under 513(e) or 513(f)(3)
120 
FDA 
calendar 
days to 
Grant/ 
Decline FDA Substantive Review
Additional information (AI)  Yes
De Novo Request placed 
needed to complete the 
on hold, request AI
substantive review?
No
No Requirements for class I 
or class II met?
Yes
Decline De Novo request;  Grant De Novo Request; 
PMA or new De Novo  device may be legally 
request required marketed
14