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Guidance Issuing OfficeCenter for Devices and Radiological Health
During the review of a premarket submission, FDA’s practice has been to communicate with applicants through either a formal communication (such as a Major Deficiency Letter or an additional information request issued through a letter, or through phone, fax, or email, with a follow-up letter confirming the hold) or through the process of Interactive Review. The concept of Interactive Review was discussed in detail in the Commitment Letter from the Secretary of Health and Human Services (the Secretary) to Congress as part of the Medical Device User Fee Act (MDUFA) II of 2007 and the process was further described in the guidance “Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements.”
The Medical Device User Fee Amendments of 20123 (MDUFA III), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2012, including premarket notification submissions (510(k)s). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical device review process.
During discussions with representatives of the medical device industry in the development of the Agency’s recommendations for MDUFA III, the Agency proposed process improvements to provide further transparency for the review process, including new communication commitments. These additional communications are in the context of: acceptance review; substantive interactions; and, if applicable, missed MDUFA goals. These communications are outlined in the MDUFA III Commitment Letter and are further described in this guidance. In addition, this guidance updates the Agency’s approach to Interactive Review to reflect FDA’s commitments in the MDUFA III Commitment Letter and to incorporate an expanded use of this communication tool to increase the efficiency of the review process.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-D-0147.