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

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

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

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

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

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

• 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).

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.

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.