SUPPORTING STATEMENT

**FOR**

**Medical Device Registration and Listing**

####### 21 CFR PARTS 807.22 & 807.31

**OMB No. 0910-0387**

**A. [JUSTIFICATION]{.underline}**

The Food and Drug Administration (FDA) is requesting an extension of
approval of the information collection requirements in 21 CFR Parts
807.22 through 807.31 and 807.40 (Attachment 1). This section describes
the procedures for domestic and foreign device establishments who must
register and submit a device list. FDA has modified FDA forms 2891,
2891(a), and 2892 by clarifying questions and improving the overall
format of the forms. FDA had observed that certain mistakes were
occurring frequently, and many of the revisions to the forms were
implemented as an effort to reduce these common types of errors. An
increase in the accuracy of the information submitted on the forms will
result in fewer communications cycles with industry and will reduce the
overall reporting and recordkeeping burden on FDA's stakeholders. In
addition, the redesign of Form 2892 will actually result in a reduction
of the number of device listing forms that a stakeholder will need to
submit.

1.  **[Circumstances Making the Collection of Information
    Necessary]{.underline}**

> Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
> (Attachment 2) requires that domestic establishments engaged in the
> manufacture, preparation, propagation, compounding, assembly, or
> processing of medical devices intended for human use and commercial
> distribution register their establishments and list the devices they
> manufacture with the Food and Drug Administration (FDA). This is
> accomplished by completing FDA Form 2891, "Registration of Device
> Establishments" and FDA Form 2892 "Medical Device Listing."
> (Attachment 3) The term "device" is defined in section 201(h) of the
> FD&C Act and includes all in vitro diagnostic products and in vitro
> diagnostic biological products not subject to licensing under section
> 351 of the Public Health Service Act (42 U.S.C. 262). The FDA
> Modernization Act of 1997 (FDAMA) added a requirement for foreign
> establishments to appoint a United States Agent and submit the
> information to FDA as part of its initial and updated registration
> information. Rather than create an additional form for the submission
> of this information, FDA has chosen to add the collection of this
> information to FDA Form 2891.
>
> The regulations for registration and listing are in 21 CFR Parts
> 807.22 through 807.31, and 807.40.

**[21 CFR 807.22(a) - REPORTING]{.underline}**

> Describes how and where to register establishments and list devices.
> This section explains that the establishment should first register on
> Form FDA-2891 (Registration of Device Establishment) and subsequent
> annual registration shall be accomplished on form FDA-2891a (Annual
> Registration of Device Establishment). FDA will furnish Form 2891a to
> establishments whose registration for that year was validated under 21
> CFR 807.35(a). The completed form shall be mailed to the FDA 30 days
> after receipt. Additional updating is required when changes occur in
> ownership, establishment name, official correspondent, or addresses.
> FDA must be notified in writing within 30 days of such changes. In the
> past, a letter had to be submitted which identified the establishment
> and described the changes. Establishments often fail to submit a
> piece(s) of required information when sending a letter informing FDA
> of changes. Because of problems receiving all of the necessary
> information, FDA has chosen to use Form 2891 as the method by which
> all changes will be submitted.
>
> **[21 CFR 807.22(b) - REPORTING]{.underline}**
>
> Specifies that the initial listing of devices and subsequent June and
> December updating shall be on form FDA-2892 (Medical Device Listing).
> Forms are obtainable upon request from FDA, and a separate form
> FDA-2892 shall be submitted to list multiple devices for each
> establishment registered with FDA. This change in process is expected
> to reduce the number of device listing forms submitted by a
> stakeholder. For example, currently if the establishment needs to list
> two different classified devices, they have to submit two forms. FDA's
> new process now only requires a single form that lists both devices.
> If variations in size, package shape, color, or composition exist, the
> device should be considered to be one device provided the variation
> does not change the function or intended use of the device.
>
> **[21 CFR 807.31(e) - REPORTING]{.underline}**
>
> States that each owner or operator must be prepared to submit to FDA,
> upon specific request, copies of all labeling and advertising,
> statements of basis that the device is not a restricted device or a
> drug, and the name of distributors for whom a device has been
> manufactured under a label other than its own.
>
> **[21 CFR 807.31 - RECORDKEEPING]{.underline}**
>
> Requires each owner or operator to maintain an historical file
> containing the labeling and advertisements in use on the date of
> initial listing and in use after October 10, 1978, but before the date
> of initial listing. In addition, they shall maintain in the historical
> file any labeling or advertisements in which materials change has been
> made anytime after the initial listing. These files must be maintained
> for a period of 3 years after the date of the last shipment of a
> discontinued device by an owner or operator and made available when
> requested by FDA.
>
> **[21 CFR 807.40 - REPORTING]{.underline}**
>
> Describes the role of the United States (US) Agent. The US Agent must
> reside or have a physical place of business in the Untied States.
> States that each foreign establishment must submit US agent
> information as part of its initial and updated registration process.
> In an effort to simplify this reporting requirement, the US Agent data
> is now a part of Form 2891 and 2891(a).

**2. [Purpose and Use of the Information]{.underline}**

> This information collection is necessary for the FDA to assure that
> devices are not adulterated or misbranded and are otherwise safe and
> effective for human use. The information will aid FDA in protecting
> the public from potentially hazardous devices, as well as devices with
> confirmed hazards. FDA analyzes the information as it is submitted,
> checking for problems in individual reports, and analyzing accumulated
> data to determine trends. Results of these analyses are utilized to
> determine if an FDA action is necessary, and if so, what action is
> appropriate.
>
> FDA is required to inspect manufacturers of certain medical devices to
> ensure that the devices are manufactured in accordance with good
> manufacturing practices. This information is used to identify
> geographic distribution in order to effectively allocate FDA field
> resources for these inspections and to identify the class of the
> device that determines the inspection frequency. In addition, when
> complications occur with a particular device or component,
> manufacturers of similar or related devices can easily be identified.
> If the firms did not submit this information, they would not be
> inspected regularly and defective devices could remain on the market,
> presenting potential life-threatening situations to the public.

**3. [Use of Information Technology and Burden Reduction]{.underline}**

> There are no technical or legal obstacles to the collection of this
> information.
>
> FDA continues to evaluate current program efficiency and provide
> recommendations on possible streamlining of the program. These
> initiatives include not only programmatic changes, but processing and
> data submission enhancements as well.
>
> One of the projects is the ability for industry to submit all
> registration and listing data electronically via the Internet. The
> registration and listing process will be converted to a paperless
> process, both for initial and updated submissions, and will permit
> real‑time updates for the first time FDA will eliminate all paper
> forms (FDA forms 2891, 2891a, and 2892) and use the FDA Unified
> Registration and Listing System (FURLS). Although some firms may not
> subscribe to an Internet service provider, FDA believes ready access
> is available through multiple channels: local libraries, FDA district
> offices, and commercial services such as Kinko's. Other federal
> agencies, notably the Securities and Exchange Commission, the Federal
> Communications Commission, and the Internal Revenue Service have
> already instituted electronic filing requirements that specifically
> exclude parallel paper submissions. The proposed regulation will
> solicit comments on the need for a "hardship exemption" for firms that
> do not have a personal computer capable of connecting to the Internet
> or the alternative FDA WWW server.
>
> While this paperless process is being developed, FDA allows medical
> device establishments to use a PDF enabled version of the forms FDA
> 2891 and 2892. FDA internal data files on registration and listing
> have been converted to online systems to reduce the processing burden
> and to provide information in a more timely manner. FDA makes nearly
> all registration and listing data available to the public via the
> Internet. In addition, FDA provides a web based mechanism that allows
> the public to search for device classification names and other
> information. All of this information is updated monthly.

**4. [Efforts to Identify Duplication and Use of Similar
Information]{.underline}**

> The FDA is the only Federal agency responsible for the collection of
> such information, and the only agency charged with the responsibility
> of regulating medical devices and establishments. Therefore, no
> duplication of data exists.

**5. [Impact on Small Business or Other Small Entities]{.underline}**

> The requirements set forth in this regulation do not fall
> disproportionately upon small businesses. The threshold assessment
> conducted for this regulation shows that no more than 22 percent of
> the anticipated annual impact of these regulations should be
> attributed to small business establishments. The FDA continues to
> pursue ways and means of reducing the reporting burden for both small
> and large medical device manufacturers and will continue to employ the
> latest technology for receipt of reports, consistent with the intent
> of the regulation and protection of the public health.
>
> FDA aids small business in dealing with the requirements of the
> regulation by providing guidance and information through the Division
> of Small Manufacturers, International and Consumer Assistance
> (DSMICA), and through the Device Registration and Listing Branch
> within the Center for Devices and Radiological Health. DSMICA provides
> workshops and other technical and non-financial assistance to small
> manufacturers. The workshops make available publications and
> educational materials, which include medical device establishment and
> listing requirements. The Division also maintains a toll-free "800"
> telephone number which firms may use to obtain regulatory compliance
> information.
>
> These efforts help to assure that the burden on small manufacturers is
> minimized.

**6. [Consequences of Collecting the Information Less
Frequently]{.underline}**

> The Federal Food, Drug, and Cosmetic Act requires that a firm: (1)
> initially register once; (2) update the registration annually; (3)
> initially list a device when it is placed into commercial
> distribution; and (4) update the listing whenever there is a change or
> discontinued device. A less frequent collection of information would
> not be responsive to the requirements of the FD&C Act or provide
> current information relative to device establishments and the listing
> and/or discontinuance of various medical device products they market.

**7. [Special Circumstances Relating to the Guidelines of 5 CFR
1320.5.]{.underline}**

> This information collection is consistent with the guidelines
> prescribed in 5 CFR 1320.5.

**8. [Comments in Response to the Federal Register Notice and Efforts to
Consult Outside Agency]{.underline}**

> In accordance with 5 CFR 1320.8(d), October 29, 2004 (69 FR 63156), a
> 60-day notice for public comment (Attachment 4) was published in the
> Federal Register. No comments were received from the public.

FDA continually seeks input from industry representatives as well as
trade associations concerning registration and listing policies and
procedures. Over the last three years FDA has sent annual letters
explaining how to avoid making the most common errors when completing
the forms and informing establishments of any proposed regulatory
changes. In addition, the Registration and Listing website is updated
routinely and FDA staff give presentations about pertinent topics at
workshops with industry. FDA maintains an email account where questions,
comments and concerns can be submitted. Replies are usually sent out
within 2 working days of receipt. Comments can also be submitted to FDA
via their web site.

**9. [Explanation of Any Payment or Gift to Respondents]{.underline}**

> No payment or gifts shall be provided to respondents under this
> regulation.

**10. [Assurance of Confidentiality Provided to
Respondent]{.underline}**

> Confidentiality of information submitted to FDA is governed by the
> provisions of 21 CFR 807.95. All registration and some listing data
> collected is available upon request under the Federal Freedom of
> Information Act, subject to FDA's implementing regulations, 21 CFR
> Part 20, Public Information. In addition, all information filed by a
> registrant is available for public inspection as required by 21 CFR
> 807.37.

**11. [Justification for Sensitive Questions.]{.underline}**

> This information collection does not include questions pertaining to
> sexual behavior, attitude, religious beliefs, or any other matters
> that are commonly considered private or sensitive in nature.

**12. [Estimate of Hour Burden Including Annualized Hourly
Costs]{.underline}**

> The following is the estimated annual burden hours for medical device
> establishments to report in compliance with the provisions imposed by
> this regulation.
>
> The annual reporting cost to respondents for registering
> establishments and listing devices is \$472,500. This figured was
> derived by multiplying the total reporting burden hours from Table 1B
> by an hourly rate of \$50. This hourly rate is based on a 2,080 annual
> work hours and at an annual salary rate of \$104,000. This health care
> professional salary rate includes salary, benefits, overhead,
> technical staff, support staff, etc. This annual rate was determined
> by the Agency's current estimates of staff expenses.
>
> FDA bases the estimates on FY03 data from current systems and on
> conversations with industry and trade association representatives, and
> from internal review of the documents listed in the below table.

The estimate of burden for this collection of information is shown in
the following tables:

**Table 1A. \--Estimated [Year 1]{.underline} Annual Reporting Burden**

**FOR INFORMATION PURPOSES ONLY**

+---------+---------+---------+---------+---------+---------+---------+
| 21 CFR  | FDA     | Number  | Annual  | Total   | Hours   | Total   |
| Section | Form    | of      |         | Annual  | Per     | Hours   |
|         |         |         | Fr      |         |         |         |
|         |         | Resp    | equency | Re      | R       |         |
|         |         | ondents | of      | sponses | esponse |         |
|         |         |         |         |         |         |         |
|         |         |         | R       |         |         |         |
|         |         |         | esponse |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 2,900   | 1       | 2,900   | .25     | 725     |
| 7.22(a) | 2891    |         |         |         |         |         |
| &       |         |         |         |         |         |         |
|         | Regis   |         |         |         |         |         |
| 807.40  | tration |         |         |         |         |         |
|         | of      |         |         |         |         |         |
|         | Device  |         |         |         |         |         |
|         | Es      |         |         |         |         |         |
|         | tablish |         |         |         |         |         |
|         | ment--- |         |         |         |         |         |
|         | initial |         |         |         |         |         |
|         | and     |         |         |         |         |         |
|         | updates |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 4,400   | 1       | 4,400   | .50     | 2,200   |
| 7.22(b) | 2892    |         |         |         |         |         |
|         | Medical |         |         |         |         |         |
|         | Device  |         |         |         |         |         |
|         | Listing |         |         |         |         |         |
|         | --      |         |         |         |         |         |
|         | initial |         |         |         |         |         |
|         | and     |         |         |         |         |         |
|         | updates |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 25,100  | 1       | 25,100  | .25     | 6,275   |
| 7.22(a) | 2891    |         |         |         |         |         |
| &       | (a)     |         |         |         |         |         |
| 807.40  | Annual  |         |         |         |         |         |
|         | Regis   |         |         |         |         |         |
|         | tration |         |         |         |         |         |
|         | of      |         |         |         |         |         |
|         | Device  |         |         |         |         |         |
|         | Establi |         |         |         |         |         |
|         | shments |         |         |         |         |         |
|         | --      |         |         |         |         |         |
|         | regis   |         |         |         |         |         |
|         | tration |         |         |         |         |         |
|         | update  |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      |         | 200     | 1       | 200     | .50     | 100     |
| 7.31(e) |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| Total   |         |         |         |         |         | 9,300   |
| Year 1  |         |         |         |         |         |         |
|         |         |         |         |         |         |         |
| Burden  |         |         |         |         |         |         |
| Hours   |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+

There are no capital costs or operating and maintenance costs associated
with this collection of information.

**Table 1B. \--Estimated Subsequent Years Annual Reporting Burden**

+---------+---------+---------+---------+---------+---------+---------+
| 21 CFR  | FDA     | Number  | Annual  | Total   | Hours   | Total   |
| Section | Form    | of      |         | Annual  | Per     | Hours   |
|         |         |         | Fr      |         |         |         |
|         |         | Resp    | equency | Re      | R       |         |
|         |         | ondents | of      | sponses | esponse |         |
|         |         |         |         |         |         |         |
|         |         |         | R       |         |         |         |
|         |         |         | esponse |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 3,100   | 1       | 3,100   | .25     | 775     |
| 7.22(a) | 2891    |         |         |         |         |         |
| &       |         |         |         |         |         |         |
|         | Regis   |         |         |         |         |         |
| 807.40  | tration |         |         |         |         |         |
|         | of      |         |         |         |         |         |
|         | Device  |         |         |         |         |         |
|         | Es      |         |         |         |         |         |
|         | tablish |         |         |         |         |         |
|         | ment--- |         |         |         |         |         |
|         | initial |         |         |         |         |         |
|         | and     |         |         |         |         |         |
|         | updates |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 4,600   | 1       | 4,600   | .50     | 2,300   |
| 7.22(b) | 2892    |         |         |         |         |         |
|         | Device  |         |         |         |         |         |
|         | Listing |         |         |         |         |         |
|         | --      |         |         |         |         |         |
|         | initial |         |         |         |         |         |
|         | and     |         |         |         |         |         |
|         | updates |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Annual  | 25,100  | 1       | 25,100  | .25     | 6,275   |
| 7.22(a) | Regis   |         |         |         |         |         |
| &       | tration |         |         |         |         |         |
|         | of      |         |         |         |         |         |
| 807.40  | Device  |         |         |         |         |         |
|         | Establi |         |         |         |         |         |
|         | shments |         |         |         |         |         |
|         | --      |         |         |         |         |         |
|         | regis   |         |         |         |         |         |
|         | tration |         |         |         |         |         |
|         | update  |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      |         | 200     | 1       | 200     | .50     | 100     |
| 7.31(e) |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| Total   |         |         |         |         |         | 9,450   |
| Year    |         |         |         |         |         |         |
| 2&3     |         |         |         |         |         |         |
|         |         |         |         |         |         |         |
| Burden  |         |         |         |         |         |         |
| Hours   |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+

There are no capital costs or operating and maintenance costs associated
with this collection of information.

####### 

####### Using FY03 data, FDA estimates that recordkeeping (Table 2 below) costs for respondents is \$923,400. This figure was determined by multiplying the total number of hours estimated for recordkeeping (32,400) by \$28.50. Historical submissions, trend analysis and estimates for annual cost of living increases at 3% determined the hourly rate.

####### 

####### Table 2 -- Estimated Annual Recordkeeping Burden

  ----------- --------------- -------------- ----------- -------------- -----------
  21 CFR      Number of       Annual         Total       Hours per      Total Hours
  Section     Recordkeepers   Frequency per  Annual      Recordkeeper   
                              Recordkeeper   Records                    

  807.31      16,200          4              64,800      .50            32,400

  Total                                                                 32,400
  Burden                                                                
  Hours                                                                 
  ----------- --------------- -------------- ----------- -------------- -----------

**13. [Estimate of the Other Total Annual Cost Burden to Respondent or
Recordkeepers]{.underline}**

> There are no additional costs associated with this information
> collection.

**14. [Annualized Cost to the Federal Government]{.underline}**

> FDA anticipates that the federal government will incur the following
> costs:

**[Staff Costs]{.underline}**

Total annual cost to the Federal Government = \$1,528,775

Full time Equivalents = 6

Annual Cost per FTE=\$104,000

Annual Cost = \$624,400

Contract Costs = \$ 904,775 - We currently pay for the temporary
secretarial assistance and the services of an 8A contractor to process
all registration and listing submissions.

**15. [Explanation for Program Changes or Adjustments]{.underline}**

> The explanation for adjustments from the previous approval is:

-   The number of respondents has changed. We report numbers based on
    the current findings from our automated database which provides us
    with submission numbers and rates. Based on FY03 data, the number of
    active registered establishments has increased. The explanation for
    this increase is that 1) better communication with industry
    regarding the need for firms to register and 2) due to changes in
    the regulations foreign firms must now register. This change was not
    taken into consideration when the previous supporting statement was
    developed. The number of listing forms submitted to FDA is shown to
    increase only slightly. There would have been a more dramatic
    increase in the number of forms if FDA had not revamped the form.
    The new form allows for the submission of listing information by
    establishment rather than by product code. It is projected that
    there will be 35 percent fewer forms submitted using this new
    format. This change in the form will make reporting listing
    information more efficient for industry and easier for FDA to
    process. Burden for this information collection does decrease by
    24,611 hours, which is the previous burden of 66,461 hours minus the
    current burden of 41,850 hours.

**16. [Plans for Tabulation and Publication and Project Time
Schedule]{.underline}**

> FDA does not intend to publish the results of this information
> collection.

**17. [Reason(s) Display of OMB Expiration Date is
Inappropriate]{.underline}**

> Currently, CDRH is not requesting an exemption for display of the OMB
> expiration date.

**18. [Exceptions to Certification for Paperwork Reduction Act
Submissions]{.underline}**

> Currently, CDRH is not requesting an exemption to Certification for
> the Paperwork Reduction Act Submissions.

**19. [Certification for Paperwork Reduction Act
Submissions]{.underline}**

No exceptions have been identified.

**B. [Collection of Information Employing Statistical
Methods]{.underline}**

> There are no statistical methods being employed in this collection of
> information.

**LIST OF ATTACHMENTS:**

Attachment 1 - Code of Federal Regulations (21 CFR 807, Subpart B, Parts
807.20 through 807.31, and 807.40)

Attachment 2 - Federal Food, Drug, and Cosmetic Act, Section 510

Attachment 3 - Medical Device Registration and Listing Forms FDA 2891,
2891a, and 2892

Attachment 4 - Federal Register 60 day Notice