2011-5146. Medical Device Reporting; Malfunction Reporting Frequency

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 § 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 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.