FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals

FOOD

DRUG

ADMINISTRATION

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 [email protected]. 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

[email protected].

U.S. Department of Health and Human Services

Food and Drug 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-Guidanc[email protected] 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, [email protected], 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 2022

(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

Congress

and are further described below.

See Title II of the FDA User Fee Reauthorization Act of 2022 (Public Law 117-180).

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.

Contains Nonbinding Recommendations

On October 5, 2021, FDA issued a final rule on the De Novo Classification Process.

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, FDA’s guidance documents do not establish legally enforceable responsibilities.

Instead, guidances describe the Agency’s 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

“Medical Device De Novo Classification Process” (86 FR 54826) at https://www.federalregister.gov/d/2021-

21677

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.

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));

See section 513(f)(2) of the FD&C Act.

Contains Nonbinding Recommendations

• the devices’s 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 device’s indications for use or

technological characteristics (21 CFR 860.260(c)(11)).

Contains Nonbinding Recommendations

FDA’s 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.

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 requester’s 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:

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.

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));

• 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.

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,

at the requester’s request and resources permitting, but not to the

detriment of meeting the quantitative review timelines, FDA will discuss with the

Available at https://www.fda.gov/media/102699/download.

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.

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.

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 Requests”

2019, and updated the guidance in 2021 in conjunction with the issuance of a final rule for

the De Novo classification process,

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,”

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,”

for more information about eCopy requirements and the

guidance entitled “Providing Regulatory Submissions for Medical Devices in Electronic

https://www.fda.gov/media/158308/download

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-

classification-requests

“Medical Device De Novo Classification Process” (86 FR 54826) at https://www.federalregister.gov/d/2021-

21677

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-and-refunds-de-novo-

classification-requests

See FDA’s 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.

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.

https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-

electronic-and-paper-format-cber-regulated-products

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-

submissions

Contains Nonbinding Recommendations

Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic

Act”

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.

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.”

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.

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

and identify the inaccurate or irrelevant information, and the De Novo will be placed

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-

submissions-medical-devices-electronic-format-submissions-under-section-745ab

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.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-

classification-requests

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.

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.

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

Action

Review Time

(FDA days)

Fiscal Year Performance Level

FY 2023

70%

FY 2024

70%

MDUFA

FY 2025

70%

Decision

(grant/decline/

150

FY 2026

70%

(80% if FY 2023 goal is met)

withdraw)

FY 2027

70%

(80% if FY 2023 goal is met/

90% if FY 2024 goal is met)

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.

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.

Contains Nonbinding Recommendations

E. Missed MDUFA Decision Communication

At Industry’s 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 FDA’s 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 Submissions”

and “Providing Regulatory Submissions for Medical

Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food,

Drug, and Cosmetic Act.”

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 requester’s 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).

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-

submissions

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-

submissions-medical-devices-electronic-format-submissions-under-section-745ab

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 requester’s 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.