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Regulatory Consultation


Understanding US (FDA) regulation is important for following a streamlined path to market for many life science products. During a Regulatory Consult, innovators talk with professionals who may have worked at the FDA, led preclinical or clinical development campaigns, and who understand how to find, interpret, and integrate important regulatory information into their planned work activities. An incomplete list of topics regularly discussed during these consults includes understanding the most likely regulatory approval/clearance required for your product, reviewing public information relevant to your product, and planning for interactions with the FDA.

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To complement our consult program, we developed a suite of plain-language resources describing common regulatory development questions and activities. Grouped by product type, we hope these documents, case studies, and short videos are helpful to your product-development work.

regulatory devices
Medical Devices
Information and case studies describing FDA regulation of therapeutic devices and digital health products
regulatory drugs
Information and case studies describing FDA regulation of small molecule and biologically derived therapeutics
regulatory diagnostics
Information and case studies describing the CMS and FDA-based regulatory requirements for laboratory developed and FDA regulated diagnostic tests