Global Regulatory Pulse

FDA Issues New Draft Guidance Document for Pre-Submissions

In Consulting, FDA, Regulatory by Dennis Crane

In response to the goals set forth within the 2017 Medical Device User Fee Amendment (MDUFA IV), the U.S. Food & Drug Administration (FDA) issued on June 7, 2018, a new Draft Guidance for Pre-Submissions, intended to replace the September 29, 2017 Final Guidance.

Although the Draft Guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” is very similar in content to the prior version, the key differences impacting medical device manufacturers are:

  • Guidance has been significantly simplified, decreasing the document from 57 to 27 pages.
  • Additional clarity has been provided for when a Pre-Submission is recommended. In doing so, additional types of submissions have been included: Dual 510(k)s, CLIA Waiver of Application Submissions (Duals), Accessory Classification Requests, Feedback on Medical Device Development tools and recognition of publicly accessible genetic variant databases.
  • It has been clarified that other agencies may also be invited to Pre-Submission meetings; specific examples include: the Centers for Medicare and Medicaid Services (CMS), private payers and/or the National Institutes of Health (NIH) grant reviewers.
  • Additional guidance has been provided regarding the types of questions which can be addressed in a Pre-Submission, including general guidelines and many specific examples.
  • Detailed guidance has been added with regards to the desired format for minutes created by the company to document Pre-Submission meetings.
  • The criteria surrounding the acceptance of checklists has been significantly revised and simplified; clarified are items that may potentially lead to a refusal decision.
  • Timelines for specific actions and responses have been clarified.
    • One key difference within the Draft Guidance is that FDA has committed to prioritize Pre-Submission meetings which are submitted within 30 days of an FDA hold letter.
    • These Pre-Submissions will receive feedback within 21 days rather than the standard 70 days.

To access the FDA’s Pre-Submission Draft Guidance, please click here.

Comment Period Open through August 7, 2018
Comments pertaining to this new Draft Guidance are due by August 7, 2018, and may be electronically submitted to https://www.regulations.gov. Written comments may be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

How can NAMSA Help?

NAMSA is the industry leader in driving successful Pre-Submission meetings. Our teams of regulatory, statistical, quality, preclinical, and clinical research Associates have countless years of experience working for, and with, the FDA. Not only do we understand how to obtain the most meaningful feedback possible throughout the Pre-Sub process, but we also possess unmatched experience on how to utilize this data to accelerate regulatory submissions, and ultimately, product approvals.

If you are interested in speaking with us about FDA-related activities and regulatory strategies, please contact us at: communications@namsa.com or 1-419-666-9455.

Additional Resources
Access our most recent blog post on “Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings” here.

Also available are various on-demand webinars that address effective management of FDA-related activities; click here to access.

About the Author
Dennis Crane currently serves as NAMSA’s Director for North America Regulatory Consulting Services.  Mr. Crane has over 30 years’ experience in achieving U.S. FDA, EU and other international regulatory medical device approvals and registrations.  He has successfully managed multiple pre-submission meetings with FDA.  In addition, Mr. Crane has designed and executed numerous clinical studies both in the U.S. and internationally, designed and monitored preclinical research and oversaw creation and maintenance of labeling.