Provided by: Compliance4all

FDA Regulation of Combination Products

Police and Law Enforcement

Compliance4all
Attend this 60 minutes presentation to gain a fundamental understanding of FDAa ™s regulation of Combination Products.
Related Jobs or Careers: Regulatory professionals working in the field of combination products
This is primarily webinar training
Course Level:advanced
Duration:60 minutes
Training Presented in:English
Training Provided by Compliance4all
FDA Regulation of Combination Products
Overview:
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
Under 21 CFR 3. 2 (e), a combination product is defined to include:
A product comprised of two or more regulated components (i. e., drug/ device, biologic/ device, drug/ biologic, or drug/ device/ biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e. g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose); or
Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
A combination product is assigned to an Agency Center or alternative organizational component that will have primary jurisdiction for its premarket review and regulation. Under section 503(g)(1) of the Act, assignment to a center with primary jurisdiction, or a lead center, is based on a determination of the "primary mode of action" (PMOA) of the combination product.
A combination product is assigned to an Agency Center or alternative organizational component that will have primary jurisdiction for its premarket review and regulation. Under section 503(g)(1) of the Act, assignment to a center with primary jurisdiction, or a lead center, is based on a determination of the "primary mode of action" (PMOA) of the combination product.
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