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In the feasibility clinical phase (e.g., conducting initial clinical research outside the U.S.)?

April 26, 2017clinical clinical research conducting feasibility initial outside phase

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In the feasibility clinical phase (e.g., conducting initial clinical research outside the U.S.)?

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Yes, the company is required to submit a license application to obtain approval to manufacture medical devices or drugs for human use, regardless if product will be used in California, the U.S. or exported. California Health and Safety Code (HSC) Sections 109920 defines device and specifically states “Intended for use in…humans or any other animal.” HSC Section 109925 uses similar terminology to define drugs.