FDA Regulatory Consultation — IVD Relabeler + Dietary Supplement Launch (1-Hour Scoping Call)

I'm a US-based founder launching a premium women's health and intimate wellness brand. I need a 1-hour paid consultation with an FDA regulatory specialist to map the regulatory pathway across four products. I'm seeking a specialist, not a generalist. WHAT I NEED FROM THE CALL A 1-hour consultation covering: - Relabeler pathway under 21 CFR 809.30; confirmation of obligations and timeline as initial distributor - Specific considerations for relabeling a PMA-approved product versus a 510(k)-cleared product - FDA establishment registration and device listing requirements for a relabeler / initial distributor - Quality System Regulation (21 CFR 820) obligations; what applies to a relabeler versus a manufacturer - Medical Device Reporting (21 CFR 803) procedures and adverse event handling system requirements - UDI / GUDID registration scope and timing - Labeling compliance; what must be preserved from the underlying manufacturer's clearance, what can be customized, and where the brand has flexibility - DSHEA framework requirements for the dietary supplement; claim language, required disclaimers, and how DSHEA obligations interact with the device obligations on the same brand - Realistic regulatory timeline for Phase 1 launch - Common mistakes you see early-stage brands make in this pathway WHAT I'M LOOKING FOR IN A CONSULTANT Required: - Specific IVD / in vitro diagnostic regulatory experience - Demonstrated 510(k) experience for diagnostic / rapid test products - Familiarity with the PMA framework (does not need to be a primary specialty, but you should be confident discussing PMA-approved product relabeling) - DSHEA / dietary supplement framework experience, OR willingness to refer me to a complementary specialist for that portion - US-based, current with FDA enforcement priorities - Comfortable working with launch-stage brands Strongly preferred: - RAC certification (or equivalent credential) - Former FDA experience (especially CDRH, ORA, or OIVD) - Specific relabeler / private-label engagement experience - Experience with at-home / OTC diagnostic launches AFTER THE CALL - A brief written summary of recommendations and any next-step engagement options (approx. 1–2 pages) - Clarity on whether ongoing engagement makes sense, and if so, in what structure (hourly, retainer, project-based) WHEN APPLYING, PLEASE INCLUDE 1. General availability over the next 2 weeks 2. Any clarifying questions you have for me I'm happy to sign a mutual NDA before sharing brand-specific details. Looking forward to your proposal!