#475: Rethinking FDA Guidance: Why Non-Binding Documents Define Your Regulatory Strategy

What this episode covers

Mike Drues, president of Vascular Sciences, explains that FDA guidance documents represent the agency's 'current thinking' rather than binding law, urging manufacturers to treat them as tactical starting points rather than immutable rules. He argues that while regulations (CFR) carry legal weight, guidance can be deviated from if justified, and recommends using the pre-submission process to address these deviations early. Drues highlights the limitations of the CDRH guidance database, noting it lacks revision history, and suggests using broader search tools like Google and direct engagement with the Office of Industry and Consumer Education (OICE) to track updates and in-development documents.