Regulatory Services
A well-prepared FDA meeting resolves regulatory uncertainties that, left unaddressed, would cause submission deficiencies and delays. A poorly prepared meeting wastes the opportunity — and FDA's goodwill. The meeting package is the document that determines whether you get useful answers or vague commitments.
Prepare Your FDA MeetingMeeting Strategy
FDA offers several types of pre-submission meeting formats for medical device manufacturers. The Pre-Submission (Q-Sub) is the most broadly used mechanism — it allows sponsors to request FDA feedback on proposed study designs, testing plans, submission content, and other regulatory questions before a formal submission is filed. Q-Sub meetings can be requested as in-person, teleconference, or written response only, depending on the complexity of the questions and the timeline. FDA's guidance on the Q-Sub program describes the content requirements for a Q-Sub package and the expected 90-day response timeline.
Pre-IDE meetings are requested before filing an Investigational Device Exemption application — they allow FDA to provide input on the proposed clinical study design, risk analysis, and device description before the IDE is submitted. Pre-PMA meetings are requested before filing a Pre-Market Approval application, typically to align on the proposed PMA format, the clinical evidence strategy, and any outstanding issues from pre-submission interactions. Type A, B, and C meeting designations apply to combination product programs and drug/biologic meetings — for pure device programs, Q-Sub is the standard mechanism.
FDA meeting packages must include a device description, the current stage of development, specific questions with accompanying background information, and the sponsor's proposed answers to each question. The proposed answers are critical — FDA reviewers do not answer questions cold. They review the sponsor's proposed answer and either agree, disagree, or provide a modified position. A meeting package that includes well-reasoned proposed answers with supporting data references gives FDA something to react to. A meeting package that just asks questions without proposed answers tends to produce hedged, non-committal FDA responses.
Question formulation is the highest-value element of meeting preparation. Questions that are too broad ("What studies do we need?") produce general answers. Questions that are specific and bounded ("Does FDA agree that ASTM F2132 peel strength testing at the specifications described in the attached protocol table satisfies the bench performance requirements for this device type?") produce actionable commitments. We draft meeting questions and proposed answers in the format that maximizes the likelihood of specific, useful FDA responses.
FDA meetings are not negotiations — they are structured information exchanges where both parties have obligations. The sponsor's obligation is to present information clearly and listen to FDA's responses. FDA's obligation is to provide the most informed feedback possible given the information provided. Understanding the difference between FDA's binding commitments and informal guidance during a meeting is essential for interpreting meeting outcomes correctly. We participate in FDA meetings on clients' behalf and provide real-time interpretation of FDA responses.
Post-meeting follow-up includes reviewing FDA's official meeting minutes, identifying any discrepancies between the verbal meeting and the written record, and documenting the agreed-upon path forward in the regulatory strategy. Meeting minutes sent by FDA are not automatically accurate — they must be reviewed and, if inaccurate, corrected through formal dispute resolution within the comment period FDA provides.
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The value of an FDA meeting is entirely in the preparation. We build meeting packages designed to elicit the specific, binding FDA responses that remove uncertainty from your regulatory program.