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Manufacturer of a Covered Drug, Device, Biological, or Medical Supply
Understanding the Role of a Manufacturer of a Covered Drug, Device, Biological, or Medical Supply
Definition & Meaning
The term manufacturer of a covered drug, device, biological, or medical supply refers to any entity involved in the creation or preparation of these products. This includes activities such as production, compounding, and conversion. Additionally, entities that are under common ownership and provide support in marketing, promotion, sale, or distribution of these products are also considered manufacturers.
Table of content
Legal Use & context
This term is commonly used in healthcare and pharmaceutical law, particularly in regulations surrounding the manufacture and distribution of medical products. Legal practitioners may encounter this term in contexts involving compliance, liability, and regulatory oversight. Users may find legal forms related to manufacturing agreements, compliance certifications, and product liability claims helpful in navigating these legal areas.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
Example 1: A pharmaceutical company that manufactures a new medication is classified as a manufacturer of a covered drug.
Example 2: A medical device company that produces surgical instruments and also provides marketing support through a subsidiary is considered a manufacturer under this definition.
Relevant laws & statutes
According to 42 USCS § 1320a-7h (e)(9), the definition of a manufacturer of a covered drug, device, biological, or medical supply is established. This statute outlines the roles and responsibilities of manufacturers in the healthcare sector.
Comparison with related terms
Term
Definition
Key Differences
Distributor
An entity that sells or distributes products but does not manufacture them.
Distributors do not engage in production or preparation activities.
Supplier
An entity that provides products to manufacturers or distributors.
Suppliers focus on provision rather than production or marketing.
Common misunderstandings
What to do if this term applies to you
If you believe you are a manufacturer of a covered drug, device, biological, or medical supply, it is important to ensure compliance with relevant regulations. Consider consulting with a legal professional to understand your obligations. Additionally, you can explore US Legal Forms for templates that can assist in managing your compliance and manufacturing documentation.
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