**SUPPORTING STATEMENT FOR**

**MEDICAL DEVICES; MEDICAL DEVICE REPORTING:**

**MANUFACTURER REPORTING; IMPORTER REPORTING,**

**USER FACILITY REPORTING, DISTRIBUTOR REPORTING**

**0910-0437**

**A. JUSTIFICATION**

**1. [Circumstances Necessitating Information Collection]{.underline}**

> Section 519(a)(b)&(c) of the Federal Food Drug and Cosmetic Act (Tab
> A) requires user facilities, manufacturers, and importers of medical
> devices to report adverse events involving medical devices to the Food
> and Drug Administration (FDA). On December 11, 1995, FDA published a
> notice of rule making amending 21 CFR 803 implementing section 519 of
> the Act. The regulation (Tab B) was amended to conform with the
> changes reflected in the 1997 FDA Modernization Act (FDAMA).
>
> 21 CFR 803.20 - Reporting
>
> Medical device user facilities, importers, and manufacturers are
> required to submit individual medical device adverse event reports on
> the FDA MedWatch 3500A, approved under OMB No. 0910-0291.
>
> 21 CFR 803.19 - Reporting
>
> Under this rule section 803.19 was modified to allow manufacturers,
> importers, or user facilities of medical devices to request an
> exemption or variance from the Medical Device Reporting requirements
> (MDR), 21CFR803.30, 803.40, 803.50.
>
> 21 CFR 803.30 - Reporting
>
> Under this rule user facilities are required to submit MDR reports
> when a device causes or contributes to a death or serious injury.
>
> 21 CFR 803.33 - Reporting
>
> Under this rule user facilities are required to annually submit the
> number and summary of events reported during the previous calendar
> year. (Tab C)
>
> 21 CFR 803.40 - Reporting
>
> Under this rule importers of medical devices are required to submit
> MDR death and serious injury reports to the manufacturer and the FDA.
> Importers send malfunction reports to the manufacturers of the problem
> devices, unless they are unknown, then the reports are submitted to
> FDA.
>
> 21 CFR 803.50 & 803.53 - Reporting
>
> Under this rule manufacturers of medical devices are required to
> submit MDR death, serious injury, and malfunction reports.
>
> 21 CFR 803.55 - Reporting
>
> This section requires manufacturers to submit certain baseline
> information with their first MDR report and update the information
> annually. The information is collected on FDA Form 3417. (Tab D)
>
> 21 CFR 803.18 (c) & (d) - Recordkeeping
>
> Under this rule, section 803.18 (c), user facilities are required to
> retain for two years copies of medical device adverse event reports
> submitted to FDA under this rule. Manufacturers and importers of
> medical devices are required to retain for two years after the date of
> event, or the expected life of the device which ever is greater,
> copies of medical device adverse event reports submitted to FDA under
> this rule.
>
> Under section 803.18 (d) distributors of medical devices are required
> to establish complaint records and to retain them for two years after
> the date of event, or the expected life of the device which ever is
> greater. FDAMA removed the requirement that medical device
> distributors submit MDR reports to FDA.

**2 [By Whom and for What Purpose the Information is to be
Used]{.underline}**

> Information from these reports will be used to evaluate risks
> associated with medical devices and to enable FDA to take appropriate
> regulatory measures to protect the public health.

**3. [Consideration of Information Technology]{.underline}**

> The final rule, 21CFR803.14, allows alternative appropriate
> technology. Reports can be electronically submitted with prior written
> consent from FDA. FDA has implemented a program for electronic
> submission of reports. It is currently evaluating the feasibility of
> expanding the program.

**4. [Efforts to Identify Duplication and Similar Information Already
Available]{.underline}**

> The FDA is the only Federal agency responsible for the collection of
> such information, and charged with the responsibility of regulating
> medical devices and establishments. Therefore, duplication with other
> data sources is nonexistent.

**5. [Small Businesses]{.underline}**

> The requirements set forth in the MDR 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 the regulation 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
> MDR regulation and protection of the public health.
>
> FDA aids small business by providing guidance and information through
> the Center for Devices and Radiological Health's Division of Small
> Manufacturers International and Consumer Assistance (DSMICA). The
> Division produces workshops, on-site evaluations and other technical
> and non-financial assistance to small manufacturers. In the workshops
> publications and educational materials, which include medical device
> reporting requirements, are generously distributed. DSMICA also
> maintains a toll-free \"800\" telephone number which firms may use to
> obtain regulatory compliance information. CDRH also has a postmarket
> and MDR reporting information site with detailed guidance and
> instructions on the Internet.

**6. [Consequences of Less Frequent Information Collection and Technical
or Legal Obstacles.]{.underline}**

> FDA has allowed manufacturers to report less frequently for certain
> well understood products and events.

**7. [Consistency with the Guidelines in 5 CFR 1320.5]{.underline}**

> This regulation is consistent with principles in 5 CFR 1320.5.

**8. [Consultation Outside the Agency]{.underline}**

> The Medical Device Reporting (MDR) regulation promulgated pursuant to
> the Safe Medical Devices Act of 1990 and the Medical Device Amendment
> of 1992 were finalized on December 11, 1995. Since that time, the
> agency has been in constant consultation with regulated industry
> regarding the MDR requirements. The amendments to the MDR
> requirements, required by FDAMA, reflect and respond to the concerns
> of industry.
>
> In accordance with 5 CFR 1320.8(d), on October 1, 2002, a 60-day
> notice for public comment was published in the Federal Register (67 FR
> 61638). FDA received no comments.

**9. [Payments or Gifts to Respondents]{.underline}**

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

**10. [Confidentiality of Information]{.underline}**

> Information contained in the information collections are available as
> described by 21 CFR 803.9, as amended. FDA may disclose the identity
> of a device user facility [only]{.underline} in connection with an
> action concerning a failure to report or false or fraudulent
> reporting, in a communication to the manufacturer of the device, or to
> the employees of the Department of Health and Human Services, the
> Department of Justice, and duly authorized committees and
> subcommittees of Congress.

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

> The information collection does not include questions concerning sex,
> behavior, attitudes, religious beliefs, or private matters.

**12. [Estimates of Burden Hours and Explanation]{.underline}**

> The following is a summary of the estimated annual burden hours for
> medical device manufacturers, importers, and user facilities to
> report, as well as distributors to maintain records, in compliance
> with the provisions imposed by this rule:
>
> FDA estimates the burden of this collection of information as follows:
>
> **Table 1\--Estimated Annual Reporting Burden^1^**

+--------+------------+--------------+------------+----------+------+
|        | No. of     | Annual       | Total      | Hours    | T    |
|        | R          | Frequency of | Annual     | per      | otal |
|        | espondents | Response     | Responses  | Response | H    |
|        |            |              |            |          | ours |
+--------+------------+--------------+------------+----------+------+
| >      | > 35       | > 4          | > 140      | > 3      | >    |
| 803.19 |            |              |            |          |  420 |
+--------+------------+--------------+------------+----------+------+
| >      | > 1000     | > 3          | > 3000     | > 1      | >    |
| 803.30 |            |              |            |          | 3000 |
+--------+------------+--------------+------------+----------+------+
| >      | > 1000     | > 1          | > 1000     | > 1      | >    |
| 803.33 |            |              |            |          | 1000 |
| >      |            |              |            |          |      |
| > FDA  |            |              |            |          |      |
| > Form |            |              |            |          |      |
| > 3419 |            |              |            |          |      |
+--------+------------+--------------+------------+----------+------+
| >      | > 50       | > 10         | > 500      | > 1      | >    |
| 803.40 |            |              |            |          |  500 |
+--------+------------+--------------+------------+----------+------+
| >      | > 1500     | > 34         | > 51000    | > 1      | > 5  |
| 803.50 |            |              |            |          | 1000 |
+--------+------------+--------------+------------+----------+------+
| >      | > 700      | > 5          | > 3500     | > 1      | >    |
| 803.55 |            |              |            |          | 3500 |
| >      |            |              |            |          |      |
| > FDA  |            |              |            |          |      |
| > Form |            |              |            |          |      |
| > 3417 |            |              |            |          |      |
+--------+------------+--------------+------------+----------+------+
| >      |            |              |            |          | > 5  |
|  Total |            |              |            |          | 9420 |
+--------+------------+--------------+------------+----------+------+

> ^1^ There are no capital costs or operating and maintenance costs
> associated with this collection of information.
>
> **Table 2\--Estimated Annual Recordkeeping Burden^1^**

+----------------+---------+------------+---------+----------+-------+
| > 21 CFR       | > No.   | > Annual   | > Total | > Hours  | >     |
| > Section      | > of    | >          | >       | > per    | Total |
|                | >       |  Frequency |  Annual | > Reco   | >     |
|                |  Record | > of       | >       | rdkeeper | Hours |
|                | >       | > Record   | Records |          |       |
|                | keepers | > keeping  |         |          |       |
+----------------+---------+------------+---------+----------+-------+
| > 803.17       | > 1800  | > 1        | > 1800  | > 3.3    | >     |
|                |         |            |         |          |  5940 |
+----------------+---------+------------+---------+----------+-------+
| > 803.18 (c) & | > 37550 | > 1        | > 37550 | > 1.5    | >     |
| > (d)          |         |            |         |          | 56325 |
+----------------+---------+------------+---------+----------+-------+
| > Total        |         |            |         |          | >     |
|                |         |            |         |          | 62265 |
+----------------+---------+------------+---------+----------+-------+

> ^1^ There are no capital costs or operating and maintenance costs
> associated with this collection of information.
>
> Respondents to this collection of information are businesses or other
> for profit and non-profit organizations including user facilities,
> manufacturers, and importers of medical devices.
>
> The burden cost below is based on an average wage rate of \$25 per
> hour, which represents a rate of low-to-medium salaried employees. FDA
> estimates, based on its experience and interaction with industry, that
> the group of workers represented by this wage rate will be doing most
> of the reporting and recordkeeping functions described in this
> information collection.
>
> The burdens are explained as follows:
>
> **Reporting Requirements**
>
> 21 CFR 803 requires user facilities to report incidents where a
> medical device caused or contributed a death or serious injury to the
> device manufacturer and to FDA in the case of a death. Manufacturers
> of medical devices are required to report to FDA when they become
> aware of information indicating that one of their devices may have
> caused or contributed to death or serious injury or has malfunctioned
> in such a way that should the malfunction recur it would be likely to
> cause or contribute to a death or serious injury. Device importers
> report deaths and serious injuries to the manufacturers and FDA.
> Importers report malfunctions only to the manufacturers, unless they
> are unknown, then the reports are sent to FDA.
>
> The number of respondents for each CFR section in the reporting table
> above is based upon the number of respondents entered into FDA's
> internal databases. FDA estimates, based on its experience and
> interaction with the medical device community, that all reporting CFR
> sections are expected to take one hour to complete with the exception
> of 21 CFR 803.19. Section 803.19 is expected to take approximately 3
> hours to complete because it is a new program and each respondent
> summarizes event data on a quarterly basis, but is only required to
> report the summarized data quarterly to FDA. By summarizing events,
> the total time used to report for this section is reduced because the
> respondents do not submit a full report for each event they report in
> a quarterly summary report.
>
> []{.mark}
>
> The total amount estimated for reporting, therefore, based on the
> figures above, is estimated to be \$1,485,500 (59,420 x \$25).
>
> **Recordkeeping Requirements**
>
> The agency believes that the majority of manufacturers, user
> facilities, and importers have already established written procedures
> to document complaints and information to meet the MDR requirements as
> part of their internal quality control system. There are an estimated
> 35,000 medical device distributors. Although they do not submit MDR
> reports, they must maintain records of complaints, under 803.18(d).
>
> The agency has estimated that on average, 1,800 user facilities,
> importers, and manufacturers would annually be required to establish
> new procedures, or revise existing procedures, in order to comply with
> this provision.
>
> Therefore, FDA estimates the one-time cost to respondents for
> establishing or revising procedures to be \$450,000, or \$250 per
> entity (1,800 respondents x 10 hours x \$25). For those entities, a
> one‑time burden of 10 hours is estimated for establishing written MDR
> procedures. The remaining manufacturers, user facilities, and
> importers, not required to revise their written procedures to comply
> with this provision, are excluded from the burden because the
> recordkeeping activities needed to comply with this provision are
> considered \`\`usual and customary\'\' under 5 CFR 1320.3(b)(2).
>
> The annual cost for recordkeeping to respondents is as follows. Under
> Section 803.17, FDA estimates 1800 respondents will spend
> approximately 3.3 hours to complete the requirements for this section.
> The number of respondents was estimated by consolidating the total of
> all new reporting entities together. The 3.3 hours was estimated by
> FDA, as this section deals with a respondent creating new MDR
> procedures, and is a one-time function. Total hours for this section
> is approximately 5940 hours.
>
> []{.mark}
>
> Under section 803.18, 37,550 respondents represent distributors,
> importers, and other respondents to this information collection. FDA
> estimates that it should take them approximately one and one-half
> hours to complete the recordkeeping requirement for this section.
> Total hours for this section equal 62,265 hours.
>
> []{.mark}
>
> Therefore the total recordkeeping costs, at \$25 per hour, associated
> with this collection are estimated at \$1,556,625.

**13. [Annual Costs to Respondents]{.underline}**

> Because this rule imposes no new additional responsibilities on
> respondents, no capital or operational expenses are expected as a
> result of this rule.

**14. [Government Costs:]{.underline}**

> Because this rule does not require the processing of any additional
> reports by the government, no additional costs to the government will
> be incurred as a result of this rule.

**15. [Changes in Burden]{.underline}**

> Since this collection was last approved by OMB, user facilities
> converted to annual reporting. In theory, this should have reduced,
> rather than increased burden hours for this collection. However, the
> total amount of burden hours have increased by 30,379 hours because of
> at least two changes since the last time this collection was approved.
>
> First, program changes were made so that device distributors no longer
> submit reports of adverse events to manufacturers or FDA. Although
> reports no longer need to be submitted to FDA, device distributors
> must still maintain records of complaints.
>
> Second, after careful review in preparation for this submission, it
> was noted that the burden formerly associated with distributors'
> reports was not previously transferred from the reporting to the
> recordkeeping burden section. As stated above, although distributors
> do not report, they must continue to maintain records of any
> complaint.

**16. [Statistical Reporting]{.underline}**

> No publication of information for statistical use is planned.

**17. [Exemption for Display of Effective Date]{.underline}**

> FDA is not seeking an exemption of display of effective date.

**18. [Exception to Certification Statement]{.underline}**

> There are no exceptions to the certification statement identified in
> Item 19 of OMB Form 83-I.
>
> **[List of Attachments:]{.underline}**
>
> Tab A- Section 519 of the Act
>
> Tab B - 21 CFR 803
>
> Tab C - User Facility Annual Report form FDA 3419
>
> Tab D - Baseline Report FDA Form 3417