Get the free Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and ...

This document provides guidance on the mechanisms available for applicants to request feedback from the FDA regarding medical device submissions, specifically through the Pre-Submission program and

How to fill out requests for feedback on

How to fill out Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff

1. Begin by reviewing the guidelines provided by the FDA for the Pre-Submission Program.
2. Gather all necessary documentation regarding the medical device intended for submission.
3. Clearly outline the objectives of the pre-submission, including specific questions you have for the FDA.
4. Complete the Pre-Submission Request form with accurate details about the device, including its intended use and target patient population.
5. Provide any preliminary data or findings that support your questions and objectives.
6. Submit the completed form electronically through the FDA's electronic submission gateway.
7. Prepare for the meeting with relevant data and questions, ensuring to address the FDA's feedback during the discussion.
8. After the meeting, follow up with any additional information requested by the FDA in a timely manner.

Who needs Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff?

1. Developers and manufacturers of medical devices seeking early feedback from the FDA.
2. Companies seeking to ensure compliance with regulatory standards before formal submission.
3. Organizations that are navigating complex regulatory pathways and need guidance from FDA staff.
4. Startups and new entrants to the medical device market looking for clarity on their submission strategy.

People Also Ask about

Does the FDA charge for Q-submission fees?

What is the FDA Q-submission fee? The FDA does not charge any fee for any Q-submission meeting.

What is a Q-submission?

FDA Q-Submission (Pre-IDE) meetings are formal meetings or official written correspondence between the FDA and investigators who seek FDA feedback on IDE applications (and other types of device submissions, such as humanitarian device exemptions (HDE) and De Novo requests) or study risk determinations.

What is the eCopy program for medical device submissions?

An eCopy is a digital version of your submission that contains the same content and format as the paper version. An eCopy allows the FDA to process and review the submission more efficiently, as well as facilitate electronic archiving and retrieval of information.

What is the Q submission program?

The Q-Submission (Q-Sub) Program provides medical device. manufacturers with the opportunity to engage in discussions. with FDA review teams during the product development process. There are several types of Q-Submissions, including: • Pre-Submissions (Pre-Subs)

How much does the FDA pre sub meeting cost?

There is no FDA fee, however, preparing a Pre-Sub package takes significant effort. There is also a 60 - 75 day delay from when you submit your Pre-Sub and when you receive feedback.

What is a submission issue request?

Submission Issue Requests (SIRs) - A SIR is a request for FDA feedback on a proposed approach to address issues conveyed in an IDE Letter.

What types of communication during the review of medical device submissions?

During the review of a premarket submission, FDA's practice has been to communicate with applicants through either a formal communication (such as a Major Deficiency Letter or an additional information request issued through a letter, or through phone, fax, or email, with a follow-up letter confirming the hold) or

What is the QSub process?

The qsub command will submit the script to the server defined by the destination argument. If the destination is a routing queue, the job may be routed by the server to a new destination. If the -q option is not specified, the qsub command will submit the script to the default server.

What is the difference between pre-sub and Q-sub?

The submission to the FDA is given a 'Q' identification number, and is often referred to as a Q-Sub. Thus, when referring to a Q-Sub vs. a Pre-Sub, they are the same thing. Such a request can often make the overall submission process easier, whether your marketing submission is a 510(k), de novo request, or PMA.

What is recommended when a sponsor requests a meeting with the FDA?

If sponsors or applicants are considering a request for a Type A meeting, before submitting the request they should contact the review division in either CBER or CDER to discuss the appropriateness of the request. Type A meetings should be scheduled to occur within 30 days of FDA receipt of a written meeting request.

For pdfFiller’s FAQs

What is Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff?

Requests for Feedback on Medical Device Submissions is part of the FDA's Pre-Submission program that allows device manufacturers to obtain feedback from FDA staff about their planned submissions, including clarification on regulatory requirements and expectations.

Who is required to file Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff?

Any medical device manufacturer, including startups and established companies, seeking to gain early feedback on their device submissions is encouraged to file Requests for Feedback through the Pre-Submission program.

How to fill out Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff?

To fill out the Requests for Feedback, manufacturers should provide a clear description of the device, the intended use, the regulatory pathway, specific questions for FDA, and any relevant data or information supporting their submission.

What is the purpose of Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff?

The purpose is to facilitate communication between manufacturers and the FDA, ensuring that developers understand the requirements for their submissions, identify potential issues early on, and promote successful review and approval processes.

What information must be reported on Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff?

Information to be reported includes details about the device, the intended use, specific questions to the FDA, preliminary data on safety and effectiveness, and any prior communications with the FDA regarding the device.