Document ID: FDA-2011-N-0097-0001
Agency: fda
Document Type: Notice
Title: Medical Device Reporting: Malfunction Frequency
Posted Date: 2011-03-08T05:00Z

[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Notices]
[Pages 12743-12744]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0097]

Medical Device Reporting; Malfunction Reporting Frequency

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is clarifying that 
device manufacturers and importers of all devices, including class I 
and those class II devices that are not permanently implantable, life 
supporting, or life sustaining, must continue to submit malfunction 
reports in full compliance with FDA's Medical Device Reporting 
regulation, pending future FDA notice under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments by May 9, 2011.

ADDRESSES: Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Victoria Schmid, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 3236, Silver Spring, MD 20993-0002, 301-
796-6108.

I. Background

    Title II, section 227 of the Food and Drug Administration 
Amendments Act of 2007 (FDAAA) (Public Law 110-85), amended section 
519(a) of the FD&C Act (21 U.S.C. 360i(a)), relating to the reporting 
of malfunctions to FDA under part 803 (21 CFR part 803). The 
malfunction reporting requirements for class III devices and those 
class II devices that are permanently implantable, life supporting, or 
life sustaining were not altered by FDAAA. Under the amended section 
519(a), device manufacturers and importers are to continue to submit 
malfunction reports in accordance with part 803 for all class III 
devices and for those class II devices that are permanently 
implantable, life supporting, or life sustaining, unless the Secretary 
of Health and Human Services (the Secretary) (and, by delegation, FDA) 
grants an exemption, variance from, or an alternative to, a requirement 
under such regulations under Sec.  803.19 (section 519(a)(1)(B)(i) of 
the FD&C Act).
    However, FDAAA changed malfunction reporting requirements for class 
I devices and those class II devices that are not permanently 
implantable, life supporting, or life sustaining. Under section 519(a) 
of the FD&C Act, as amended by FDAAA, the Secretary (and, by 
delegation, FDA) is required to publish a notice in the Federal 
Register or send a letter to the person who is the manufacturer or 
importer of a class I device or a class II device that is not 
permanently implantable, life

[[Page 12744]]

supporting, or life sustaining, if FDA finds that such a device should 
be subject to part 803 in order to protect the public health (section 
519(a)(1)(B)(i)(III) of the FD&C Act). If such class I or class II 
devices are not the subject of an FDA notice or letter, the malfunction 
reports for these devices are to be submitted in accordance with the 
criteria established by the Secretary (and, by delegation, FDA), which 
criteria shall require the reports to be in summary form and made on a 
quarterly basis (section 519(a)(1)(B)(ii) of the FD&C Act).
    Under section 519(a) of the FD&C Act, as amended by FDAAA, there is 
no change to the obligation for an importer to submit malfunction 
reports to the manufacturer in accordance with part 803 for devices 
that it imports into the United States (section 519(a)(1)(B)(iii) of 
the FD&C Act).
    FDA intends to provide notice in the Federal Register that lists 
the types of devices that should be subject to part 803 in order to 
protect the public health, as required by section 519(a)(1)(B)(i)(III) 
of the FD&C Act). In addition, FDA intends to, by rulemaking, establish 
malfunction reporting criteria for devices subject to section 
519(a)(1)(B)(ii) of the FD&C Act. In the interim, in the interest of 
public health, FDA is publishing this notice under section 
519(a)(1)(B)(i)(III), to clarify that, to the extent there is any 
confusion as to current malfunction reporting requirements, all device 
manufacturers and importers of class I and those class II devices that 
are not permanently implantable, life supporting, or life sustaining, 
must continue to report in full compliance with part 803, pending 
further FDA notice under section 519(a)(1)(B)(i)(III), as to specific 
devices or device types subject to part 803, and the establishment of 
criteria in accordance with section 519(a)(1)(B)(ii). FDA considers it 
necessary to subject all such devices to part 803 in the interim, in 
order to protect the public health by ensuring that there is no gap in 
malfunction reporting for any device.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5146 Filed 3-7-11; 8:45 am]
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