Pre-Sub Meeting

Allie

Registered
Hi all,

Looking to submit a pre-sub meeting request soon. This will be an introductory meeting to inform the FDA of our product and plans, and ask a few questions.
A few questions...

1) Does the FDA like to see the physical device? Should we send the device along with our request?
2) Should we include the User Guide in our Pre-Sub to help familiarize the reviewers with our device?


All feedback is appreciated. Thank you!
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Anything you would show a customer how to use it and what it does is helpful

Include as much information for them to respond to your questions. They are generally hesitant to make hard answers but provide them your strategy and ask if they agree on your pathway in general. Do they agree on the classification and the 510(k) or De Novo pathway for this.
 

EmiliaBedelia

Quite Involved in Discussions
I would not send the physical device simply for logistics reasons. You can send videos, photos, schematics, etc but to me, sending the device itself is probably more trouble than it's worth. If you have a teleconference with the FDA you can demo on video.

You should definitely send the User Guide/Instructions for Use.
 

Parul Chansoria

Regulatory and Quality Expert
Hi @Allie when deciding what information to submit in your pre-sub, think first about what questions you want to be addressed in the pre-sub and then walk backward from there.

E.g.,
  1. If you want to ask a question on applicable testing, then provide a table on all the testing you are planning to do for the device with rationale for each testing. Definitely this list should be constructed based on regulatory considerations.
  2. If you want FDA’s input on your clinical study design then try to provide a protocol, if not then provide at least a summary on what you are planning for clinical validation.
Information to include - Its always good to provide user manual, indications for use, device description, key features of the device and the mechanism in which device achieves its indications for use.

Physical device - Sending physical device is not needed. You can prepare a presentation with device 3D images, if the device is very unique, and can show them on call.

Questions - The manner in which you construct your question is very important, as that can make things more difficult or ease up things for your company, so have a solid regulatory strategy (made by thinking about all pros and cons), prior to the pre-sub. This strategy can be then revised:read: based on the FDA’s feedback obtained via the pre-sub
 
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