On August 4, 2015, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health released a new guidance document intended to provide applicants with clear and consistent guidance in the submission and initial intake evaluation process of 510(k) submissions. It explains the procedures and criteria that FDA will use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and whether it will be accepted for substantive review.

The new guidance, entitled “Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff,” is intended to supersede previously issued guidances on this issue; specifically, “Food and Drug Administration’s Refuse to Accept Policy for 510(k)s,” dated December 31, 2012, “Premarket Notification (510(k)) Refuse to Accept Policy,” dated June 30, 1993, and “510(k) Refuse to Accept Procedures (K94-1) blue book memo,” dated May 20, 1994 (unavailable). FDA expects the newly-issued guidance to streamline the initial acceptance review process and will apply to 510(k) applications that are designated as either traditional, special or abbreviated.

The process will operate as follows: effective October 1, 2015, 510(k) submissions to FDA will be subject to a structured initial intake acceptance review process (RTA review). The RTA consists of the following six questions that FDA will consider in determining the appropriateness of the submission:

  1. Is the product a device (per section 201(h) of the Federal Food, Drug, and Cosmetic Act Act) or a combination product (per 21 C.F.R. § 3.2(e)) with a device constituent part subject to review in a 510(k)?
  2. Is the submission with the appropriate center?
  3. If a Request for Designation (RFD) is submitted for the device or combination product with a device constituent part and assigned to your center, identify the RFD # and confirm the following:
  • Is the device or combination product the same (e.g., design, formulation) as that presented in the RFD submission?
  • Are the indications for use for the device or combination product identified in the 510(k) the same as those identified in the RFD submission?
  • Is this device type eligible for a 510(k) submission?
  • Is there a pending PMA for the same device with the same indications for use?
  • If clinical studies have been submitted, is the submitter the subject of the Application Integrity Policy?

The FDA has 15 days to complete the RTA review process to determine if the 510(k) submission is administratively complete, time that is included in the overall 90-day decision goal. If the submission is deemed to be missing critical elements and ineligible for substantive review, the Agency will reject it and return it for resubmission to the product sponsor. If the 510(k) is acceptable, it will continue on to substantive review, with the RTA review period counted into the 90-day decision goal. An important element of the newly-issued guidance is that now, during the RTA review, FDA staff have the discretion to contact the submitter to request missing information. Formerly, FDA staff were required to obtain management concurrence before the application was rejected as incomplete. FDA said in its guidance that “Interaction during the RTA review is dependent on FDA staff’s determination that outstanding issues are appropriate for interactive review and that adequate time is available for the submitter to provide supporting information and for FDA staff to assess responses.” 

FDA staff will review 510(k) submissions using an “Acceptance Checklist.” Each Acceptance Checklist consists of a series of questions (a “yes, no or N/A” style questionnaire) to determine the completeness of the application and whether it can progress to substantive review. The submission will be subject to questions pertaining to content, organizational style, whether certain statutory and regulatory requirements have been met, the application’s jurisdictional appropriateness, among others. FDA states in the guidance that the “overall goal of this guidance is to clarify for submitters and reviewers the content needed to allow FDA to conduct a substantive review, thereby enhancing the quality of received 510(k) submissions and improving overall review time.” 

The guidance document contains specific checklists for traditional, special or abbreviated 510(k) submissions that should be used as a step-by-step guide by submitters. The checklists will be used by reviewers to ensure a consistent review process to determine if a 501(k) submission is complete enough to undergo substantive review, and if not, to provide clarity to the submitter with regard to the additional information required to meet review eligibility requirements.

FDA states that focusing its resources on complete 510(k) submissions will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible, and will assist the Agency in meeting its performance goals based on the timeliness of reviews. Initial reactions from stakeholders indicate that the new guidance would contribute to better understanding of the 510(k) approval process. 

Electronic comments and suggestions on the guidance document may be sent at any time to the Division of Dockets Management, Food and Drug Administration, at http://www.regulations.gov. Comments may not be acted upon by the Agency until the document is revised or updated.

The guidance document, which becomes effective on October 1, 2015, is available here