Source: https://www.federalregister.gov/documents/2015/08/26/2015-21036/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2018-03-24 06:22:36
Document Index: 479558637

Matched Legal Cases: ['art 803', 'art 803', '§\u2009803', '§\u2009803', '§\u2009803', '§\u2009803', 'art 803', '§\u2009803', '§\u2009803']

Fax written comments on the collection of information by September 25, 2015.
80 FR 51820
51820-51822 (3 pages)
2015-21036
Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting (21 CFR Part 803)—(OMB Control Number 0910-0437)—Revision
https://www.federalregister.gov/d/2015-21036 https://www.federalregister.gov/d/2015-21036
Section 519(a)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) Start Printed Page 51821(21 U.S.C. 360i(a)(1)) requires every manufacturer or importer to report whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices may have caused or contributed to a death or serious injury or has malfunctioned and that such device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Section 519(b)(1)(A) of the FD&C Act requires whenever a device user facility receives or otherwise becomes aware of information that reasonably suggests that a device has or may have caused or contributed to the death or serious illness, of a patient of the facility, the facility shall, as soon as practicable but not later than 10 working days after becoming aware of the information, report the information to the Secretary of HHS and, if the identity of the manufacturer is known, to the manufacturer of the device.
Section 519(b)(1)(B) of the FD&C Act requires whenever a device user facility receives or otherwise becomes aware of information that reasonably suggests that a device has or may have caused or contributed to the serious illness of, or serious injury to, a patient of the facility, shall, as soon as practicable but not later than 10 working days after becoming aware of the information, report the information to the manufacturer of the device or to the Secretary of HHS if the identity of the manufacturer is not known.
Part 803 requires user facilities to report to the device manufacturer and to FDA in case of a death, incidents where a medical device caused or contributed to a death or serious injury. Additionally, user facilities are required to annually submit the number and summary of adverse events reported during the calendar year using Form FDA 3419. 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 Code of Federal Regulations (CFR) section in table 1 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 1 hour to complete, with the exception of § 803.19. Section 803.19 is expected to take approximately 3 hours to complete, but is only required for reporting 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.
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 medical device reporting (MDR) requirements as part of their internal quality control system. There are an estimated 30,000 medical device distributors. Although they do not submit MDR reports, they must maintain records of complaints under § 803.18(d).
Therefore, FDA estimates the one-time burden to respondents for establishing or revising procedures under § 803.17 to be 6,006 hours (1,820 respondents × 3.3 hours). For those entities, a one-time burden of 3.3 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).
Under § 803.18, 1,820 respondents represent distributors, importers, and other respondents to this information collection. FDA estimates that it should take them approximately 1.5 hours to complete the recordkeeping requirement for this section. Total hours for this section equal 2,730 hours.
Part 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 (see third-party disclosure burden table), unless the manufacturers are unknown, then the reports are sent to FDA.
FDA estimates are based on our experience and interaction with the medical device community and burden analysis from the rulemaking. Section 803.19 is expected to take approximately 1 hour to complete, 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.
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. The Agency has estimated that on average, 1,820 user facilities, importers, and manufacturers would annually be required, under § 803.17, to establish new procedures, or revise existing procedures, in order to comply with this provision. We estimate that it will take each respondent 3.3 hours annually to establish new procedures, or revise existing procedures. We estimate that it will take each respondent 1.5 hours annually to maintain the records.
Under §§ 803.40 and 803.42, device importers report deaths and serious Start Printed Page 51822injuries to the manufacturers and FDA. Importers report malfunctions only to the manufacturers, unless they are unknown, then the reports are sent to FDA. We estimate that it will take respondents 0.35 hours annually to report the information.
In the Federal Register of May 07, 2015 (80 FR 26278), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. However, since the 60-day notice, we have updated the burden estimates to reflect revisions made by the final rule, “Medical Device Reporting: Electronic Submission Requirements,” which became effective August 14, 2015.
Exemptions—803.19 56 4 224 1 224
User Facility Reporting—803.30 and 803.32 520 7 3,640 0.35 1,274
User Facility Annual Reporting—803.33 3419 520 1 520 1 520
Manufacturer Reporting—803.50, through 803.53 1,240 204 252,960 0.10 25,296
Supplemental Reports—803.56 1,050 94 98,700 0.10 9,870
Total 37,185
MDR Procedures—803.17 1,820 1 1,820 3.3 6,006
MDR Files—803.18 1,820 1 1,820 1.5 2,730
Importer Reporting, Malfunctions—803.40 and 803.42 60 25 1,500 0.35 525
[FR Doc. 2015-21036 Filed 8-25-15; 8:45 am]