FDA's New Pre-Submission Guidance: Part II

November 13, 2013

Last week’s post gave you an overview of the FDA’s new Pre-Submission program and all it entails. Today brings a more magnified view – including the exact pieces that make up a Pre-Sub request, and specific examples of what the new guidance doesn’t do.

While each Pre-Submission request is tailored to a specific product and goal, there are some general guidelines that apply to all submissions. Below is an organized list of what most submissions should include; specific scenarios might require exceptions or additions to this list.

Ingredients of a Pre-Submission Guidance request:

  1. Cover Letter – Include:
    1. Reason for submission in reference line
    2. CDRH Premarket Review Submission Cover Sheet (CBER Pre-Subs too)
    3. Complete contact information
    4. Name of device
    5. Signature(s)
    6. Addressee
    7. CDRH - Branch or Branch Chief
    8. CBER – Office Director or Regulatory Project Manager
  2. Table of Contents (use tabs or dividers, and sequential page numbering)
  3. Device Description
    1. Pictures, drawings, processes/principles used to generate output, physical/biological characteristics, samples (where feasible), user interface, interactions, materials, manufacturing (brief), mechanism of action, scientific basis or expected clinical utility, comparison to planned predicate
    2. IVDs – detailed technical description (instruments, reagents, components, software, etc.)
  4. Proposed Intended Use – Indications for Use
    1. Identification of disease/condition device is indicated for
    2. Identification of target population
    3. Body part/tissue type applied to or interacting with
    4. Frequency of use
    5. Physiological use
    6. Statement whether prescription and/or over-the-counter use
  5. Previous Submissions or Discussions (include all information)
  6. Product Development Overview
  7. Specific Questions
  8. Mechanism for Feedback
  9. Other Logistical Information (CDRH only)
    1. Clear, concise, English or Other with English translation, 3 copies (1 electronic)
    2. Pre-Sub identifier assigned by DMC

Certain requests for information do not qualify for Pre-Submission requests because they do not demand feedback. Some examples of situations that don’t require Pre-Sub guidance:

  • General information requests (contact CDRH/DSMICA or CBER/MA&TTB)
  • Policy/procedures information requests
  • Information-only meetings or calls (i.e. not looking for feedback)
  • Requests for guidance clarification, except:
    • Device types not addressed in guidance
    • Nonclinical/clinical studies not addressed in guidance
    • Requests to use means alternative to guidance
    • Phone calls/emails that can be easily addressed by reviewers
    • Interactions requested during marketing application review
    • Substitutes for existing review processes
      • E.g. 510(k), PMA, IDE, HDE, BLA, Supplements, 513(g), de novo 510(k), appeal, 513(d), etc.

Feedback from the FDA can be provided in-person, via teleconference, via facsimile, or through email. If an in-person or teleconference meeting is decided upon, the FDA will send initial feedback via email several days prior. This provides a written copy of their response and if sufficient, the meeting or teleconference can be canceled.