Stay Connected:
ITMC Systems:US FDA Pre-sub (Q-Sub) Consulting for Medical Devices

US FDA Pre-sub (Q-Sub) Consulting for Medical Devices

ITMC Systems is a dedicated consulting firm offering expert guidance and support in US FDA Pre-submission (Pre-sub or Q-Sub) consulting services for medical device manufacturers. With an experienced team of regulatory professionals and former FDA experts, we are committed to assisting clients in navigating the Pre-sub process with precision and maximizing their chances of success.

Services we offer

Pre-submission Strategy Development:

  • Comprehensive assessment of your device and regulatory objectives.
  • Customized Pre-sub strategies to address FDA questions and concerns.

Pre-submission Package Preparation

  • Assistance in compiling a thorough Pre-submission package.
  • Expert review of documentation to ensure clarity and completeness.

Meeting Request and Communication

  • Preparation of formal meeting requests and communication with the FDA.
  • Timely responses to FDA inquiries throughout the Pre-sub process.

Meeting Preparation

  • Guidance in developing briefing documents and meeting agendas.
  • Strategy for presenting information effectively during FDA meetings.

Meeting Representation

  • Expert representation during FDA Pre-sub meetings.
  • Addressing FDA questions, concerns, and clarifications on your behalf.

Feedback Analysis and Action Plan

  • Thorough analysis of FDA feedback and recommendations.
  • Development of actionable plans to address FDA suggestions.

Pre-Sub meeting submission consulting

  • Assist in developing the specific questions to the FDA for which their feedback is requested.
  • Assist in preparing Pre-Sub documentation and provide feedback on items such as intended use statement, draft product labels and Instructions for Use, etc.
  • Compile the Pre-Sub meeting request package and submit to the FDA to request a Pre-Sub meeting in-person at the FDA headquarters or by conference call.
  • Assist in the preparation for the meeting, including providing feedback on presentation materials and practicing for anticipated questions by the FDA.
  • Participation in the Pre-Sub in-person meeting or conference call with the FDA. The ITMC consultant will be available for consultation and support throughout the meeting and may address the FDA on the client's behalf (particularly useful if a language barrier is an issue) at the client's request.
  • Provision of a second consultant to take notes during the Pre-Sub meeting or conference call (this is via phone conference connection only).

How and when to start the FDA Q-Submission process

You must formally request a Pre-Sub meeting with the FDA. The contents of your Q-Sub submission for requesting a meeting should include a cover letter, a thorough description of your medical device along with its proposed intended use, the mechanism of action on the body, its technological characteristics, your planned testing strategy, and specific questions on which you are requesting input from the FDA.

You must submit your Pre-Sub meeting request before submitting your 510(k) or premarket application (PMA) review process, or before beginning a clinical study on which you are seeking feedback. There are other 'Q-Sub' meeting types that allow you to meet with the FDA for different purposes (e.g., Submission Issues meeting during the review process). However these are not as common.

How the FDA pre-sub process can help you achieve US market clearance for your device

FDA Pre-Sub consulting is available for sponsors and manufacturers to obtain regulatory feedback on various medical device- or IVD-related applications, including Investigational Device Exemptions (IDE) necessary for high risk medical device clinical investigations, premarket notification (510(k)) submissions, and clinical or non-clinical study protocols.

Topics that may be addressed using the Pre-Sub process include, but are not limited to, the following:

  • Specific preclinical performance testing required to support pre-market clearance or approval application.
  • The appropriate regulatory path for a novel device, such as the 510(k) route or a de novo application.
  • The formal designation of a device clinical study as either "significant risk" (SR) or "non-significant risk" (NSR).

The FDA Pre-Sub program can prove especially valuable for devices utilizing novel technologies, or those with indications that qualify them as "first of a kind" devices.

Why Choose Us

At ITMC Systems, we understand the importance of a well-prepared Pre-submission interaction with the FDA. Let us be your partner in achieving clarity and direction for your medical device development journey. Contact us today to get started.

  • Specialized expertise in Pre-submission consulting for medical devices across various categories.
  • Former FDA professionals and seasoned regulatory consultants on our team.
  • Proven success in helping clients achieve productive Pre-sub interactions with the FDA.
  • Customized strategies tailored to your device and regulatory goals.
  • Transparent communication, adherence to timelines, and client-focused approach.

Our Clients

Request Free Consultation