**Guidance for**

**Industry and FDA Staff**

**FDA and Industry Actions on Premarket Notification (510(k))
Submissions: Effect on FDA Review Clock and Performance Assessment**

**Document issued on: \[Level 1 IE use FR date\]**

For questions regarding submissions to the Center for Devices and
Radiological Health, contact Heather S. Rosecrans at 301-594-1190 x143
or by email at <hsr@cdrh.fda.gov>.

For questions regarding submissions to the Center for Biologics
Evaluation and Research, contact Leonard Wilson at 301-827-0373 or by
email at <wilsonl@cber.fda.gov>.

![](media/image1.png)

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Devices and Radiological Health**

![](media/image2.png){width="1.0625in" height="0.9479166666666666in"}

**Center for Biologics Evaluation and Research**

**Preface**

**Public Comment**

Written comments and suggestions may be submitted at any time for agency
consideration to Dockets Management Branch, Division of Management
Systems and Policy, Office of Human Resources and Management Services,
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305),
Rockville, MD, 20852. Alternatively, electronic comments may be
submitted to <http://www.fda.gov/dockets/ecomments>. Please identify
your comments with the docket number listed in the notice of
availability that publishes in the *Federal Register* announcing the
availability of this guidance document. Comments may not be acted upon
by the agency until the document is next revised or updated.

**Additional Copies**

Additional copies are available from the Internet at:
[[http://www.fda.gov/cdrh/\[specific]{.underline}](http://www.fda.gov/cdrh/%5Bspecific)
address\] or <http://www.fda.gov/cber/mdufma/mdufma.htm>, or by phone at
(301) 827-2000 or (800) 835-4709, or to receive this document by fax,
call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111
from a touch-tone telephone. Press 1 to enter the system. At the second
voice prompt, press 1 to order a document. Enter the document number
(**1219**) followed by the pound sign (#). Follow the remaining voice
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**Table of Contents**

[I. Introduction 1](#introduction)

[II. Purpose 2](#purpose)

[III. 510(k) Performance Goals 2](#k-performance-goals)

[IV. FDA Actions 3](#fda-actions)

[A. Issue an Order Declaring a Device SE
3](#issue-an-order-declaring-a-device-se)

[1. Criteria 4](#criteria)

[2. Effect on Review Clock 4](#effect-on-review-clock)

[3. Effect on MDUFMA Goals 4](#effect-on-mdufma-goals)

[B. Issue an Order Declaring a Device NSE
4](#issue-an-order-declaring-a-device-nse)

[1. Criteria 4](#criteria-1)

[2. Effect on Review Clock 5](#effect-on-review-clock-1)

[3. Effect on MDUFMA Goals 5](#effect-on-mdufma-goals-1)

[C. Request Additional Information (AI)
5](#request-additional-information-ai)

[1. Criteria 6](#criteria-2)

[2. Effect on Review Clock 6](#effect-on-review-clock-2)

[3. Effect on MDUFMA Goals 7](#effect-on-mdufma-goals-2)

[D. Advise the Submitter that the 510(k) is Not Required
7](#advise-the-submitter-that-the-510k-is-not-required)

[a. Not-a-Device Decision 7](#a.-not-a-device-decision)

[1. Criteria 8](#criteria-3)

[2. Effect on Review Clock 8](#effect-on-review-clock-3)

[3. Effect on MDUFMA Goals 8](#effect-on-mdufma-goals-3)

[b. Exempt from 510(k) Decision 8](#b.-exempt-from-510k-decision)

[1. Criteria 8](#criteria-4)

[2. Effect on Review Clock 8](#effect-on-review-clock-4)

[3. Effect on MDUFMA Goals 9](#effect-on-mdufma-goals-4)

[E. Issue a Notice of Withdrawal 9](#issue-a-notice-of-withdrawal)

[1. Criteria 9](#criteria-5)

[2. Effect on Review Clock 9](#effect-on-review-clock-5)

[3. Effect on MDUFMA Goals 10](#effect-on-mdufma-goals-5)

[V. Industry Actions 10](#industry-actions)

[A. Industry Submits a Response to an FDA Letter Requesting Additional
Information
11](#industry-submits-a-response-to-an-fda-letter-requesting-additional-information)

[1. Basis for Submission 11](#basis-for-submission)

[2. Effect on Review Clock 11](#effect-on-review-clock-6)

[3. Effect on MDUFMA Goals 11](#effect-on-mdufma-goals-6)

[B. Industry Submits a Response to an Informal Request for Additional
Information
11](#industry-submits-a-response-to-an-informal-request-for-additional-information)

[1. Basis for Submission 12](#basis-for-submission-1)

[2. Effect on Review Clock 12](#effect-on-review-clock-7)

[3. Effect on MDUFMA Goals 12](#effect-on-mdufma-goals-7)

[C. Industry Requests Withdrawal of the 510(k)
12](#industry-requests-withdrawal-of-the-510k)

[1. Basis for the Request 12](#basis-for-the-request)

[2. Effect on Review Clock 12](#effect-on-review-clock-8)

[3. Effect on MDUFMA Goals 13](#effect-on-mdufma-goals-8)

[D. Industry Requests an Extension of Time to Respond to an FDA Letter
Requesting Additional Information
13](#industry-requests-an-extension-of-time-to-respond-to-an-fda-letter-requesting-additional-information)

[1. Basis for the Request 13](#basis-for-the-request-1)

[2. Effect on Review Clock 14](#effect-on-review-clock-9)

[3. Effect on MDUFMA Goals 14](#effect-on-mdufma-goals-9)

**Guidance for Industry and FDA Staff**

**FDA and Industry Actions on Premarket Notification (510(k))
Submissions:**

**Effect on FDA Review Clock**

**and Performance Assessment**

***This guidance represents the Food and Drug Administration\'s (FDA\'s)
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. You
can use an alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations. If you want to
discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA
staff, call the appropriate number listed on the title page of this
guidance.***

# Introduction

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA),
Public Law 107-250, amends the Federal Food, Drug, and Cosmetic Act (the
act) to provide the Food and Drug Administration (FDA) new
responsibilities and resources. A provision of MDUFMA authorizes FDA to
collect user fees for the review of certain premarket submissions
received on or after October 1, 2002, including premarket notification
submissions (510(k)s). The additional funds obtained from user fees will
enable FDA, with the cooperation of industry, to improve the device
review process to meet the performance goals identified in the letter
from the Secretary of Health and Human Services to Congress (Goals
Letter)[^1] and summarized below.

FDA's guidance documents, including this guidance, 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.

# Purpose

The purpose of this document is to assist agency staff and the device
industry in understanding how various FDA and industry actions that may
be taken on 510(k)s should affect the review clock for purposes of
meeting the MDUFMA performance goals.

# 510(k) Performance Goals

For 510(k) submissions, the performance goals contain both cycle (i.e.,
"first action" and "second and later action") goals and decision goals.
A "cycle" (or review cycle) is the period of time (in FDA days[^2])
beginning with the date FDA receives the 510(k)[^3] and ending with the
date FDA issues a letter requesting additional information or announcing
a "decision" (e.g., substantially equivalent (SE) or not substantially
equivalent (NSE) determination). More than one cycle may occur before
FDA issues its decision on the 510(k) submission.

The table below summarizes the 510(k) performance goals under MDUFMA.
FDA has committed to meeting the following action and decision goals for
a specified percentage of submissions, depending on the fiscal year:

-   an FDA decision (i.e., issuance of a SE or NSE determination letter)
    will issue within 90 days (cumulative FDA review time)

-   first action additional information (AI) letters will issue within
    75 days

-   subsequent action additional information letters will issue within
    60 days.

**Table 1. 510(k) Performance Goals**

+------------------------+-----------+-----+-----+-----+-----+-----+
| **Action**             | **Review  | *   |     |     |     |     |
|                        | Time**    | *Pe |     |     |     |     |
|                        |           | rfo |     |     |     |     |
|                        | **(FDA    | rma |     |     |     |     |
|                        | days)**   | nce |     |     |     |     |
|                        |           | Le  |     |     |     |     |
|                        |           | vel |     |     |     |     |
|                        |           | (by |     |     |     |     |
|                        |           | FY  |     |     |     |     |
|                        |           | )** |     |     |     |     |
|                        |           |     |     |     |     |     |
|                        |           | (   |     |     |     |     |
|                        |           | --- |     |     |     |     |
|                        |           | ind |     |     |     |     |
|                        |           | ica |     |     |     |     |
|                        |           | tes |     |     |     |     |
|                        |           | no  |     |     |     |     |
|                        |           | qua |     |     |     |     |
|                        |           | nti |     |     |     |     |
|                        |           | tat |     |     |     |     |
|                        |           | ive |     |     |     |     |
|                        |           | go  |     |     |     |     |
|                        |           | al) |     |     |     |     |
+------------------------+-----------+-----+-----+-----+-----+-----+
|                        |           | **  | **  | **  | **  | **  |
|                        |           | 200 | 200 | 200 | 200 | 200 |
|                        |           | 3** | 4** | 5** | 6** | 7** |
+------------------------+-----------+-----+-----+-----+-----+-----+
| **FDA decision**       | 90        | --- | --- | 75% | 75% | 80% |
|                        |           |     |     |     |     | ^A^ |
+------------------------+-----------+-----+-----+-----+-----+-----+
| **First AI letter**    | 75        | --- | --- | 70% | 80% | 90% |
+------------------------+-----------+-----+-----+-----+-----+-----+
| **Second or later AI   | 60        | --- | --- | 70% | 80% | 90% |
| letter**               |           |     |     |     |     |     |
+------------------------+-----------+-----+-----+-----+-----+-----+

**^A^**FY 2007 FDA decision goal (80% within 90 days) may be
re-evaluated in consultation with industry to determine whether it is
appropriate for FY 2007.

# FDA Actions

FDA may take any of the following actions on a 510(k) after FDA has
conducted its review (21 CFR 807.100(a)):

-   issue an order declaring a device SE (SE letter)

-   issue an order declaring a device NSE (NSE letter)

-   request AI[^4]

-   advise the submitter that the 510(k) submission is not required
    (i.e., product is not regulated as a device or device is exempt from
    the premarket notification requirements of the act)

Further, in accordance with 21 CFR 807.87(l), the agency may consider a
510(k) to be withdrawn if additional information is not provided within
30 days following issuance of a request for additional information. In
this instance, FDA may issue a notice of withdrawal.[^5]

The following sections describe the actions FDA may take on 510(k)s,
explain when these actions may be appropriate, and discuss the effect
that each action has on the review clock and on the MDUFMA performance
goals.

## Issue an Order Declaring a Device SE

> An order declaring a device to be SE is a letter issued to the
> submitter of a 510(k) informing the submitter that FDA has determined
> that the device described in the 510(k) is substantially equivalent to
> a legally marketed device.[^6] An order declaring a device to be SE
> authorizes marketing of the device in the United States (U.S.),
> subject to specific statutory and regulatory requirements of FDA.[^7]

### Criteria

> The criteria for determining a device to be SE are described in
> section 513(i) of the act and in 21 CFR 807.100(b). Additional
> information relating to determinations of SE can be found in the
> guidance documents entitled,*"Guidance on the Center for Devices and
> Radiological Health\'s Premarket Notification Review Program"* and
> "*Determination of Intended Use for 510(k) Devices; Guidance for CDRH
> Staff."*[^8]

### Effect on Review Clock

> An SE decision is a decision that [shuts off]{.underline} the review
> clock and marks the end of FDA review. The reported FDA review time
> for the 510(k) decision is the cumulative FDA days for all review
> cycles from the date the 510(k) is received to the date the SE letter
> is issued.

### Effect on MDUFMA Goals

> In accordance with the Goals Letter, to be counted as meeting the
> MDUFMA decision goals, the SE letter should issue within 90 FDA days
> from the date the 510(k) is received if it is the first action on the
> submission; or within 90 cumulative FDA days if the SE determination
> is a second or later action.

## Issue an Order Declaring a Device NSE

> An order declaring a device to be NSE is a letter issued to the
> submitter of a 510(k) informing the submitter that FDA has determined
> that the device described in the 510(k) is NSE to a legally marketed
> device and may not be introduced into commercial distribution in the
> U.S.[^9]

### Criteria

> In general, FDA issues an NSE letter in the following situations:

-   no predicate device exists

-   the device has a new intended use compared to the predicate device

-   the device has different technological characteristics that raise
    different questions of safety and effectiveness than the predicate
    device

-   the device has new indications for use or different technological
    characteristics than the predicate device and performance data[^10]
    on the device do not demonstrate that the device is as safe and
    effective as a legally marketed device.

### Effect on Review Clock

> An NSE determination is a decision that [shuts off]{.underline} the
> review clock and marks the end of FDA review. The reported FDA review
> time for the 510(k) decision is the cumulative FDA days for all review
> cycles from the date the 510(k) is received to the date the NSE letter
> is issued.

### Effect on MDUFMA Goals

> In accordance with the Goals Letter, to be counted as meeting the
> MDUFMA decision goals, the NSE letter should issue within 90 FDA days
> from the date the 510(k) is received if it is the first action on the
> submission; or within 90 cumulative FDA days from the date the 510(k)
> is received if the NSE determination is a second or later action.

## Request Additional Information (AI)

> FDA requests AI when the 510(k) lacks information necessary for the
> agency to begin, continue, or complete the review and make a
> determination as to whether the device is SE or NSE. Requests for
> additional information may be issued by letter, telephone, fax, or
> e-mail.[^11]

a.  ***Request AI by letter ("formal" AI request)***

> A request for AI by letter refers to a request made (1) directly by
> letter or (2) first by telephone, fax, or e-mail, and then followed-up
> with a letter informing the submitter that the 510(k) is being placed
> on "hold" pending receipt of a response to all of the identified
> deficiencies.

b.  ***Request AI by means other than letter ("informal" AI request)***

> An informal request for AI refers to a request made by telephone, fax,
> or e-mail, and [not]{.underline} followed-up with a letter. An
> informal AI request does [not]{.underline} result in the 510(k) being
> placed on "hold."

### Criteria

> FDA requests AI when the information identified in 21 CFR 807.87 is
> not contained in the 510(k) submission.
>
> Note: FDA generally will utilize a maximum of three cycles of FDA
> review to reach a SE or NSE decision. The first review cycle begins
> upon receipt of the original 510(k) submission, and subsequent review
> cycles start when we receive responses to our requests for AI by
> letter. Thus, if there are multiple review cycles, FDA intends to
> issue a final decision following its review of industry's response to
> a second AI request. In general, if unresolved deficiencies exist
> following FDA's review of a response to a second AI request, FDA will
> issue an NSE letter.

a.  ***Request AI by letter (formal AI request)***

> FDA generally requests AI by letter when the agency believes the
> additional information is not minor in nature and/or cannot be
> provided within a reasonable period of time (i.e., such that the
> review will not be delayed).

b.  ***Informal AI request***

> FDA generally requests AI by means other than a letter when the agency
> believes the additional information is relatively minor in nature
> (e.g., a simple change to the device's proposed labeling) and can be
> provided quickly. Such requests are generally made when FDA believes
> the submitter can address all of the information requested within a
> reasonable period of time that will not delay the review
> [and]{.underline} the reviewer receives the 510(k) submitter's
> commitment to providing the AI by the agreed upon time.

### Effect on Review Clock

a.  ***Request AI by letter (formal AI request)***

> A request for AI by letter is an interim action that
> [stops]{.underline} the review clock and marks the end of an FDA
> review cycle. The FDA review time for this 510(k) action is the number
> of FDA days for the review cycle. The review cycle begins on the date
> FDA receives the original 510(k) submission (or supplemental
> submission in response to an AI request letter) and ends on the date
> FDA issues the AI letter.

b.  ***Informal AI request***

> An informal request for additional information [does not
> stop]{.underline} the FDA review clock because the 510(k) remains
> under review.
>
> Note: If FDA does not receive industry's response to all of the
> deficiencies in the informal AI request within the agreed upon time,
> FDA may issue a letter placing the 510(k) on "hold" to stop the clock.

### Effect on MDUFMA Goals

a.  ***Request AI by letter (formal AI request)***

> In accordance with the Goals Letter, to meet the MDUFMA decision
> goals, requests for AI should issue as early as possible in the review
> cycle so that the cumulative number of FDA review days does not exceed
> 90. In accordance with the Goals Letter, to be counted as meeting the
> MDUFMA cycle goals, FDA should issue the first AI request letter
> within 75 days from the date the original 510(k) submission is
> received or, for a second AI request, within 60 FDA days from the date
> of receipt of the submitter's response to all of the deficiencies
> identified in the first AI request.

b.  ***Informal AI request***

> This 510(k) action has no effect on the MDUFMA goals because this
> action does not affect the review clock.

## Advise the Submitter that the 510(k) is Not Required 

> FDA believes that it is the responsibility of a manufacturer to
> initially determine whether a 510(k) submission is required based on
> the act, device regulations, and guidance documents. The Division of
> Small Manufactures Assistance, International, and Consumer Assistance,
> the Program Operations Staff, the review division, and product
> classification resources on the CDRH website at
> <http://www.fda.gov/cdrh/devadvice/313.html> can help you ascertain
> whether your device is exempt by regulation. You may also obtain
> information regarding the regulatory status of your device or product
> by submitting a 513(g) request.[^12]

### a. Not-a-Device Decision

> A "not-a-device" letter informs the submitter that the product
> described in the 510(k) is not regulated as a device.

### Criteria

> FDA sends a "not-a-device" letter when FDA has determined that the
> product described in the 510(k) does not meet the definition of
> "device" in section 201(h) of the act.

### Effect on Review Clock

> The issuance of a "not-a-device" letter [shuts off]{.underline} the
> review clock and marks the end of FDA review. The FDA review time for
> this 510(k) decision is the cumulative FDA days from the date the
> 510(k) is received to the date the not-a-device letter issues.

### Effect on MDUFMA Goals

> The MDUFMA goals do not include a performance goal for this action, so
> "not-a-device" decisions will not be counted towards the goals.
> Nevertheless, FDA intends to process 510(k)s with an exempt decision
> within a timely manner.

### b. Exempt from 510(k) Decision

> An "exempt" letter informs the 510(k) submitter that the device
> described in the 510(k) is classified as exempt from the premarket
> notification requirements of section 510(k) of the act.

### Criteria

> FDA sends an "exempt" letter when FDA determines that the device
> described in the 510(k) is exempt by regulation from the premarket
> notification requirements of section 510(k) of the act. Exemptions are
> found in 21 CFR 807.20(c), 807.65 and 807.85, as well as individual
> classification regulations (21 CFR Parts 862-892).

### Effect on Review Clock

> The issuance of an "exempt" letter is a decision that [shuts
> off]{.underline} the review clock and marks the end of FDA review. The
> reported FDA review time for the 510(k) decision is the cumulative FDA
> days for all review cycles from the date the 510(k) is received to the
> date the exempt letter is issued.

### Effect on MDUFMA Goals

> The MDUFMA goals do not include a performance goal for this action, so
> "exempt" decisions will not be counted towards the goals.
> Nevertheless, FDA intends to process 510(k)s with an exempt decision
> within a timely manner.

## Issue a Notice of Withdrawal

> A notice of withdrawal informs the 510(k) submitter that FDA considers
> the 510(k) to be withdrawn (21 CFR 807.87(l)). The letter represents a
> final FDA decision to end its review of the 510(k) submission because
> the submitter failed to submit a timely response to an AI letter that
> placed the submission on hold.

### Criteria

> FDA may issue a notice of withdrawal for a 510(k) that is on hold for
> AI if the submitter fails to submit a timely response to all of the
> deficiencies identified in the AI letter. In accordance with 21 CFR
> 807.87(l), FDA may consider a 510(k) to be withdrawn if the submitter
> fails to provide additional information within 30 days of a request.
> In the past, FDA has not strictly enforced this timeframe and has
> allowed submitters additional time to respond to requests for AI. The
> agency intends to continue this practice of allowing additional time.
> In general, FDA intends to issue a notice of withdrawal in accordance
> with the following procedures:

-   If the submitter **does not** submit a written request for an
    extension to the Document Mail Center, as per 21 CFR 807.90,
    [and]{.underline} **does not** provide a response to all of the
    deficiencies in the AI request within 90 days of the request, FDA
    intends to consider the 510(k) to be withdrawn.

-   If the submitter **does** submit a written request for an extension
    and the request is received within 90 days of the date of the AI
    request, FDA intends to permit the 510(k) to remain on hold for up
    to 180 days from the date of the AI request. FDA intends to consider
    the 510(k) to be withdrawn if the agency does not receive a complete
    response to all of the deficiencies in the AI request within 180
    days of the date of the AI request.

### Effect on Review Clock

> Because the 510(k) is on hold at the time the agency issues a notice
> of withdrawal, an FDA notice of withdrawal does not affect the time
> clock. The FDA review time for this action will be measured as the
> number of days from the beginning of the FDA review until the request
> for AI. If there are multiple requests for AI, subsequent cycles will
> begin when FDA receives a complete response to the AI and end when the
> agency sends out an additional request.

### Effect on MDUFMA Goals

> The MDUFMA goals do not include a decision goal for this action.
> However, the agency will report its performance on the cycle goals for
> those applications whose review ends with a notice of withdrawal. In
> accordance with the Goals Letter, to be counted as meeting the cycle
> goals, FDA should issue the first AI letter within 75 days from the
> date the agency receives the original 510(k) submission or, for a
> second AI request, within 60 days from the date FDA receives the
> submitter's response to all deficiencies identified in the first AI
> request.

# Industry Actions

Industry actions after submitting a 510(k) are generally limited to
providing AI to FDA. Submitters should provide information requested by
FDA within the timeframes discussed below.

Industry actions include the following submissions to a pending 510(k):

-   a response to an FDA letter requesting AI

-   a response to an informal AI request

-   a request to withdraw the 510(k)

-   a request for an extension of time to respond to an FDA request for
    AI

All of the above industry actions, with the exception of the submission
of a response to an informal AI request, must be submitted by letter to
the appropriate Center within FDA, in accordance with 21 CFR
807.90.[^13]

The following sections describe the industry actions, explain the basis
for each industry action, and discuss the effect that each action has on
the review clock and on the MDUFMA performance goals.

## Industry Submits a Response to an FDA Letter Requesting Additional Information

> A response to an FDA AI letter is the submission of additional
> information, addressing identified deficiencies, that allows FDA to
> continue or complete the substantive review and make a decision on the
> 510(k).

### Basis for Submission

> The submitter should provide a [complete]{.underline} response to a
> letter from FDA requesting AI. The response should address
> [all]{.underline} of the deficiencies identified by the agency in its
> letter.

### Effect on Review Clock

> Industry's submission of a response to an FDA AI letter is an action
> that, upon receipt by FDA, [restarts the FDA review
> clock]{.underline}, i.e., a new 90-day review clock starts upon
> receipt of the AI.
>
> Note: If, however, FDA determines that the submitter has not addressed
> one or more of the deficiencies identified in the AI letter, the
> review cycle should be terminated until FDA receives a response
> addressing the remaining deficiencies. In such a case, FDA should
> inform the submitter by telephone, fax, or e-mail that the response is
> incomplete and, therefore, the [clock has not restarted.]{.underline}

### Effect on MDUFMA Goals

> In accordance with the Goals Letter, to be counted as meeting the
> MDUFMA decision goals, a final decision letter should issue within 90
> cumulative FDA days from the date the 510(k) is received. In
> accordance with the Goals Letters, to be counted as meeting the MDUFMA
> cycle goals, FDA should act on a submission containing a complete
> response to an FDA AI letter within 60 days of its receipt.

## Industry Submits a Response to an Informal Request for Additional Information 

> A response to an informal request for AI is the submission to FDA of
> additional information, addressing previously identified deficiencies,
> by letter, telephone, fax, or e-mail, that allows the agency to
> continue or complete the substantive review and make a decision on the
> 510(k).

### Basis for Submission

> The submitter should provide a response to all of the deficiencies
> after receiving FDA's informal request for AI.
>
> Note: As explained above in Section IV(C), FDA makes an informal
> request for AI when FDA believes the submitter can address all of the
> information requested within a reasonable period of time that will not
> adversely affect the review [and]{.underline} the reviewer receives
> the submitter's commitment to providing the AI by the agreed upon
> time.

### Effect on Review Clock

> Industry's submission of a response to an informal FDA request for AI
> is an action that [does not affect]{.underline} the review clock
> because the 510(k) remains under review while the request is pending.
>
> Note: If the agency does not receive industry's response to all of the
> deficiencies within the agreed upon time, FDA may issue a letter
> placing the 510(k) on "hold" and stop the review clock.

### Effect on MDUFMA Goals

> Industry's submission of a response to a FDA informal request for AI
> has no effect on the MDUFMA goals because this action does not affect
> the review clock.

## Industry Requests Withdrawal of the 510(k)

> A request to withdraw a 510(k) informs the agency of the submitter's
> intention to discontinue its pursuit of FDA review of the device at
> this time.[^14]

### Basis for the Request

> The 510(k) submitter may request withdrawal of the pending 510(k) at
> any time, and for any reason, after it is submitted for review but
> before FDA renders its final decision.

### Effect on Review Clock

> Industry's submission of a request to withdraw a pending 510(k) is an
> action that [shuts off]{.underline} the review clock. If the 510(k) is
> under review at the time FDA receives the withdrawal request, the
> review clock should stop on that date. If the 510(k) is on hold at the
> time FDA receives the withdrawal request, the review clock should
> remain stopped as of the date the 510(k) was last placed on hold for
> AI. The reported FDA review time for the 510(k) is the cumulative FDA
> days for all review cycles from the date the submission is originally
> received to the date the withdrawal request is received, or the date
> the submission was last placed on hold, as applicable.

### Effect on MDUFMA Goals

> The MDUFMA goals do not include a decision goal for this action.
> However, the agency will report its performance on the cycle goals for
> applications whose review ends with a request for withdrawal. In
> accordance with the Goals Letter, to be counted as meeting the cycle
> goals, FDA should issue the first AI letter within 75 days from the
> date the agency receives the original 510(k) submission or, for a
> second AI request, within 60 days from the date of receipt of the
> submitter's response to all deficiencies identified in the first AI
> request.

## Industry Requests an Extension of Time to Respond to an FDA Letter Requesting Additional Information

> An industry request for an extension of time to respond to an AI
> letter informs the agency of the 510(k) submitter's wish to extend the
> response time identified in FDA's request.

### Basis for the Request

> In the past, FDA has not strictly enforced the 30 day timeframe
> identified in requests for AI and has allowed submitters additional
> time to respond to such requests. The agency intends to continue to
> allow additional time for responses. If the submitter needs more than
> 90 days to respond to the deficiencies in an AI letter, the submitter
> should send a letter requesting an extension to the Document Mail
> Center.
>
> Note: FDA intends to issue a notice of withdrawal if it does not
> receive a request for additional time.[^15] (Refer to section IV. E*.
> Issue a Notice of Withdrawal* for additional discussion of FDA actions
> regarding requests for extension.) Even in those situations where a
> submitter does request an extension, FDA does not intend to keep
> 510(k)s indefinitely on hold while awaiting the AI. Therefore, in
> general, FDA intends to issue a notice of withdrawal if the submitter,
> who has requested an extension, fails to provide a complete response
> within 180 days from the date of the AI request.

### Effect on Review Clock

> A request for an extension of time to respond to an AI request [does
> not affect]{.underline} the FDA review clock because the 510(k)
> remains on hold.

### Effect on MDUFMA Goals

> Industry's submission of a request for an extension has no effect on
> the MDUFMA goals because this action does not affect the review clock.

[^1]: This letter can be found at
    <http://www.fda.gov/cdrh/mdufma/pgoals.html>)

[^2]: The term "FDA days" refers to the amount of time a submission is
    under review by FDA and does not include the time when the clock has
    been stopped.

[^3]: The recorded receipt date of a 510(k) submission is the date the
    submission is received by FDA or the date US Bank notifies FDA that
    payment of all fees due has been received, whichever is later. For
    additional information, see
    <http://www.fda.gov/cdrh/devadvice/314a.html>

[^4]: Includes requests for a certification or disclosure statement as
    per 21 CFR 807.100(a)(4).

[^5]: A notice of withdrawal is sometimes referred to as a "deletion
    letter." The term "deletion" is used to differentiate a withdrawal
    under 21 CFR 807.87(l) from a request to withdraw a pending 510(k)
    by the submitter.

[^6]: See 21 CFR 807.92(a)(3) for the definition of "legally marketed
    device."

[^7]: See section 513(i) of the act.

[^8]: These two guidance documents are located at
    <http://www.fda.gov/cdrh/k863.html> and
    <http://www.fda.gov/cdrh/ode/guidance/857.html>, respectively.

[^9]: See section 513(i) of the act.

[^10]: This may include data that are inadequate or inconclusive.

[^11]: For CDRH, refer to Blue Book memorandum entitled *"Fax & E-mail
    Communication with Industry about Premarket Files Under Review,"*
    located at <http://www.fda.gov/cdrh/ode/a02-01.html>; for CBER,
    request a secure e-mail account through the Regulatory Project
    Manager.

[^12]: For products regulated by CDRH, requests for classification
    information under section 513(g) of the act should be submitted to
    the attention of the 513(g) Coordinator, Food and Drug
    Administration, Center for Devices and Radiological Health, 510(k)
    Document Mail Center (HFZ-401), 9200 Corporate Boulevard, Rockville,
    MD 20850. For products regulated by CBER, 513(g) requests should be
    submitted to the CBER Ombudsman, Center for Biologics Evaluations
    and Research, Suite 200 North, HFM-4, 1401 Rockville Pike,
    Rockville, MD 20852-1448.

[^13]: See *"Fax & E-mail Communication with Industry about Premarket
    Files Under Review,"* <http://www.fda.gov/cdrh/ode/a02-01.html> for
    additional information about time frames and responsibilities.

[^14]: See *"Fax & E-mail Communication with Industry about Premarket
    Files Under Review,"* <http://www.fda.gov/cdrh/ode/a02-01.html> for
    information on 510(k) withdrawal procedures.

[^15]: In accordance with 21 CFR 807.87(l), FDA may consider a 510(k) to
    be withdrawn if the submitter fails to provide additional
    information within 30 days of a request. As explained in Section IV.
    E., FDA generally permits submitters additional time to respond to
    such requests.