Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.” This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and identify the reporting requirements for both recalls and product enhancements. This draft guidance is not final nor is it in effect at this time.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 23, 2013.
Submit written requests for single copies of the draft guidance document entitled “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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.
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FOR FURTHER INFORMATION CONTACT:
Ron Brown, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2654, Silver Spring, MD 20993-0002, 301-796-6163.
Defects or performance failures of marketed medical devices can pose serious risks to public health. Recalls serve both to correct the defect in current and future devices and to notify users of potential risks and steps to minimize the impact of device failure or function. The recall process establishes a mechanism for firms that produce and market medical devices to take timely action to correct violative devices or remove them from the marketplace when correction or removal is necessary to protect the public health.
When a firm's recall process is operating effectively, the firm identifies a device defect or failure, determines a recall is appropriate, and triggers the initiation of the recall process. However, firms may have trouble identifying whether a change to a device meets the definition of a recall, the appropriate scope of a recall, and when FDA should be notified of a recall. These issues can result in delays in notifying the public about unsafe medical devices.
FDA also recognizes that continuous improvement activities, as part of an effective quality system, often have a favorable impact on medical device safety and are part of ongoing efforts to design and manufacture devices that meet the needs of the user and patient. When new iterations of a device involve improvements to device design, it does not necessarily mean that the existing device needs to be recalled. Such changes may be appropriately characterized instead as product enhancements.
In addition to determining whether a proposed change to a marketed device meets the definition of a device recall or Start Printed Page 12330a product enhancement, a firm must make a separate assessment on whether it is required to report the change to FDA.
The guidance is organized in a question-and-answer format, providing responses to questions that FDA believes are helpful in properly identifying medical device recalls and applying the reporting requirements.
II. Significance of Guidance
The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the difference between a recall and an enhancement to an existing premarket approval application (PMA) or 510(k). It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. To receive “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements,” you may either send an email request to firstname.lastname@example.org to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number 1819 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
The draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 7, subpart C have been approved under OMB control number 0910-0249; the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910-0437; and the collections of information in 21 CFR part 810 have been approved under OMB control number 0910-0432.
Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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, and will be posted to the docket at http://www.regulations.gov.
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Dated: February 15, 2013.
Assistant Commissioner for Policy.
[FR Doc. 2013-04060 Filed 2-21-13; 8:45 am]
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