FDA Compliance: Comprehensive Guidance for Medical Devices and Dietary Supplements
The U.S. Food and Drug Administration (FDA) oversees a wide array of medical devices, spanning from latex gloves (Class I) to artificial hearts (Class III). The agency scrutinizes these devices to ensure their safety and effectiveness before permitting their sale or use by the public, through a rigorous approval review and registration process that verifies and documents device safety and efficacy.
The documentation necessary to establish the baseline safety and effectiveness of a medical device depends on its intended use, indicated use, and associated risks. Most low-risk Class I devices are exempt from pre-market notification, while most Class II devices require pre-market notification, and the majority of high-risk Class III devices necessitate comprehensive documentation and pre-market approval. All medical devices are subject to listing, labeling, quality, and reporting obligations.
Companies and individuals engaged in manufacturing, repackaging, relabeling, or importing medical devices for sale in the United States must comply with disclosure, reporting, and control requirements set forth by the Center for Devices and Radiological Health (CDRH).
Our FDA Compliance Practice for Medical Devices includes:
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Labeling advice and opinions: Ensuring compliance with FDA labeling requirements.
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Establishment registration and reporting: Navigating the FDA's registration and reporting processes.
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Advising device manufacturers on FDA regulation compliance: Providing expert guidance on adhering to FDA rules and regulations.
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Inspections and recalls: Assisting with FDA inspections and managing recalls if necessary.
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Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplement companies are responsible for ensuring the safety of their products and substantiating any representations or claims with adequate evidence to demonstrate that they are neither false nor misleading. Consequently, dietary supplements do not require FDA approval before marketing, except for new dietary ingredients, which mandate pre-market review of safety data and other pertinent information.
FDA regulations dictate that specific information must be included on dietary supplement labels, such as a descriptive product name, the manufacturer's name and business address, a complete list of ingredients, and net product contents. Additionally, most dietary supplements must feature nutrition labeling in the form of a "Supplement Facts" panel, which identifies each dietary ingredient contained in the product.
Our FDA Compliance Practice for Dietary Supplements includes:
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Labeling advice and opinions: Ensuring compliance with FDA labeling requirements for dietary supplements.
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Establishment registration and reporting: Navigating the FDA's registration and reporting processes for dietary supplements.
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Advising manufacturers on FDA regulation compliance: Providing expert guidance on adhering to FDA rules and regulations for dietary supplements.
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Inspections and recalls: Assisting with FDA inspections and managing recalls for dietary supplements when necessary.
