Manufacturers shall interact with FDA using Q-Submissions program. They can request clarification regarding medical device submissions.
The following feedback
mechanism are described in guidance
- Pre-Submissions
- Informational Meetings
- Study Risk Determinations
- Formal Early Collaboration Meetings
- Submission Issue Meetings
- Day 100 Meetings for PMA Applicants
Q-Submission requests
must be submitted through the Document Control Center (DCC). Two copies are
required (One copy must be an electronic copy or eCopy).
FDA shall share the acknowledgement
letter containing Q number to the applicant.
Q-Sub Type:
Pre-Submissions
- This type of submission used during product development and/or application preparation
- Voluntary program and no user fees required
- Feedbacks are received mainly through in-person meeting, teleconference or email
- Timeframe is 75 to 90 days and FDA will respond with in 21 days for urgent public health issues
Recommended
information
- Cover Letter
- CDRH Premarket Review Submission Cover Sheet (Form FDA 3514)
- Table of Contents
- Detailed Device Description
- Proposed Intended Use/Indications for Use
- Summary of Previous Discussions or Submissions Regarding the Same Device
- Overview of Product Development
- Specific Questions for FDA Feedback
- Preferred method to receive FDA Feedback
- Meeting Format, Preferred Dates and Times, Planned Attendees, and Audiovisual Equipment Needs, if meeting or teleconference is requested
Q-Sub Type:
Informational Meetings
- Manufacturer will
share the information to FDA without expecting any feedback.FDA is in listening mode.
- Timeframe: 90 days
Recommandated information:
- Cover Letter
- CDRH Premarket Review Submission Cover Sheet
- Brief Statement
- Proposed Agenda
- Preferred Meeting Format
- Dates and Times (minimum of three)
- Planned Attendees
- Audiovisual Equipment Needs, if any
Q-Sub Type: Study Risk
Determinations
- Used to determine a study risk determination for not exempt studies.
- FDA will provide a study determination letter and FDA’s determination is final
Recommended information:
- Cover Letter
- CDRH Premarket Review Submission Cover Sheet
- Detailed Device Description
- Study Protocol
- Description of how the device will be used
- Description of the population
- Sponsor’s name and contact person(s), including titles, address, phone number, fax number and email address
Q Sub
Type-Formal Early Collaboration Meetings
There are two types.
1.Determination
Meeting: Applicable for PMA or PDP applicant.
FDA shall determine
the type of valid scientific evidence that will be necessary to demonstrate
that the device is effective for its intended use.FDA shall assess whether
clinical studies are needed to establish effectiveness
2. Agreement Meeting:
Applicable for class III product or any implant.
This meeting is
conducted to reach agreement on the key parameters of the investigational plan,
including the clinical protocol
Q Sub
Type- Submission Issue Meetings
- This meeting is used to discuss the deficiencies identified during premarket applications
- Time frame:21 days
Recommended information:
- Cover Letter
- CDRH Premarket Review Submission Cover Sheet
- Reference to Premarket Submission Number
- Brief Statement (including purpose, scope, or objectives of meeting)
- Proposed Agenda Including Deficiencies for Discussion
- Focused Questions
- Preferred Meeting Format
- Preferred Dates and Times (minimum of three)
- Planned Attendees
- Audiovisual Equipment Needs, if any
Q Sub Type- Day 100 Meetings for PMA Applications
This
meeting is to review the status of PMA .
Click here to know more about Guidance on PMA
Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies – for
Use by CDRH and Industry
References :
Requests for Feedback
on Medical Device Submissions: The PreSubmission Program and Meetings with Food
and Drug Administration Staff: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGu
idance/GuidanceDocuments/UCM311176.pdf
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