The FDA CDRH Pre-Submission, or Pre-sub, is a type of Q-Submission that provides manufacturers an opportunity to communicate with the FDA about their planned product submissions. A Pre-sub allows you to have a meeting with the FDA to discuss your plan.
Some benefits to the Pre-Sub:
- These meetings may be very beneficial when preparing a submission for a new device that does not clearly fall within an established regulatory pathway.
- These meetings may be very beneficial prior to initiating long term preclinical studies.
- These meetings may be beneficial when planning a study that does not require an IDE i.e. studies outside of US or exempt or non-significant risk (NSR) devices.
- These meetings may be beneficial before the submission to discuss non-clinical data and clinical study design
- These meetings may be beneficial before submission of a marketing application. As the manufacturer, you can apprise the FDA review team on specifics of the device and clinical study data if there have been changes since initiation of an IDE, obtain feedback on preferred data presentation, or gain insight into the potential hurdles for approval or clearance.
- and many more...
The following documents and information should be part of your FDA Pre-submission:
Cover letter that includes the following information:
- Designation of meeting request type aka Q-Sub type i.e. Pre-sub,
- Manufacturer name & contact information
- Product Name
- Regulatory History
- Planned Follow-on Submission
- Background Information
- Device Description
- Proposed Predicate Devices (if applicable)
- Intended Use/Indications for Use Statement
- Description of How the Device is Planned to be Used
- Risk Analysis
- Discussion of Relevant Prior Information
- Proposed Study Design
- Specific Questions
- Meeting Attendees
- Proposed Meeting Dates (unless written feedback is requested).
*Reference the latest FDA Guidance on Q-subs and Pre-submission requirements here. Note - the FDA frequently updates their websites and guidances. As of October 2019, the guidance is only a draft guidance and may change in the future.
Other pre-submission requirements
Here are some additional requirements as it relates to your FDA Pre-submission:
- 1 eCopy and 1 hard-copy are required to be submitted
- An electronic copy (eCopy) is defined as an exact duplicate of the paper submission, created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. Check out the latest guidance from FDA on eCopy requirements.
- An eCopy is accompanied by a paper copy of the signed cover letter and the complete paper submission.
- The cover letter signature may be a wet (i.e., ink) signature or a valid digital signature
Mail Pre-sub to the following address:
Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center – WO66-G609
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Here is an outline of the FDA Pre-submission process:
1. Sponsor submits to the Document Control Center (see mailing address above)
2. FDA conducts acceptance review (14 days)
3. Meeting/Teleconference requested:
a. FDA works with manufacturer to schedule the meeting/teleconference (21 days)
b. FDA provides preliminary feedback via email (at least one week prior to the meeting/teleconference)
4. FDA provides feedback (70 days)
5. After Meeting/Teleconference held:
a. Manufacturer provides draft minutes to Document Control Center (15 days)
b. FDA reviews/edits minutes (30 days)
Disclaimer - This post intended for informational purposes and does not constitute legal information or advice. The materials are provided in consultation with US federal law and may not encompass state or local law.