SUPLEMENTARY INFORMATION:

I. Background

The purpose of the 510(k) acceptance review is to make a threshold determination whether a submission is administratively complete, which determines whether it should be accepted for substantive review to reach a determination regarding substantial equivalence under section 513(i) of the FD&C Act, 21 U.S.C. 360c(i). To find a device substantially equivalent under section 513(i) of the FD&C Act, FDA must find that it has the same intended use as the predicate device, and either: (1) Has the same technological characteristics as the predicate device, or (2) has different technological characteristics, as defined at section 513(i)(1)(B), and (3) the submission contains information, including appropriate clinical or scientific data if necessary, that demonstrates the device is as safe and effective as the predicate and does not raise different questions of safety and effectiveness from the predicate.

The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a 510(k) submission is administratively complete and should be accepted for substantive review. This guidance document provides updated information to two existing guidance documents entitled “Center for Devices and Radiological Health's Premarket Notification (510(k)) Refuse to Accept Policy” issued on June 30, 1993 and “510(k) Refuse to Accept Procedures, 510(k) Memorandum K94-1” issued on May 20, 1994. Upon issuance as a final guidance document, this guidance will replace those documents.

To further focus the Agency's review resources on complete applications, which will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible, we have modified the 1993 and 1994 guidances. For example, we have modified the 510(k) Refuse to Accept (RTA) policy to include an early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days of receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s). In order to enhance the consistency of our acceptance decisions and to help submitters better understand the types of information FDA needs to conduct a substantive review, this guidance, including the checklists included in the appendices, clarifies the necessary elements and contents of a complete 510(k) submission. These elements are applicable to all devices reviewed through the 510(k) notification process in CDRH and CBER and have been compiled into checklists for use by FDA review staff.

In the Federal Register of August 13, 2012 (77 FR 48159), FDA announced the availability of the draft guidance document. Interested persons were invited to comment by September 27, 2012. Eleven sets of comments were received with multiple recommendations pertaining to the administrative processes and policies regarding 510(k) acceptance decisions.

A number of commenters expressed concern that the checklist questions related to performance data implied that FDA staff would need to conduct a level of substantive review in order to complete the checklist. FDA has revised the language in these questions and added further instructions to FDA staff to more specifically state that only the presence of the information is required for acceptance, and that the adequacy of the information should only be assessed after acceptance and as part of the substantive review.

Similar comments were received regarding questions in the checklists that identified an “analysis” or “discussion” as a criterion for acceptance. Commenters were concerned that FDA staff would be assessing the adequacy of the “analysis” or “discussion” in order to complete the checklist. These questions have also been modified to explain more clearly that the acceptance criterion requires only that the “analysis” or “discussion” be present; the adequacy of this information should be assessed during the substantive review.

FDA received comments regarding relevant prior submissions and how prior FDA feedback relevant to determining substantial equivalence has been addressed in the submission under ( printed page 101) review. It was suggested that FDA identify a particular location within the submission for this information, noting that such information could be found in multiple locations. The guidance has been revised to suggest more specific locations within the submission where this information can be provided for the ease of compiling a 510(k) and to facilitate FDA staff's acceptance review.

Other comments provided editorial suggestions for clarity and for consistency with other FDA guidance documents. In response to these comments, FDA revised the guidance document to clarify the processes and policies as appropriate. This guidance supersedes the guidances “Center for Devices and Radiological Health's Premarket Notification (510(k)) Refuse to Accept Policy” issued on June 30, 1993 and “510(k) Refuse to Accept Procedures, 510(k) Memorandum K94-1” issued on May 20, 1994.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on the refuse to accept policy for 510(k)s. 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 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 “Refuse to Accept Policy for 510(k)s,” you may either send an email request to dsmica@fda.hhs.gov 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 1793 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This guidance refers to currently 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 807, subpart E, have been approved under OMB control number 0910-0120.

V. Comments

Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES ) or electronic comments to http://www.regulations.gov. 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.