Understanding Combination Product: Legal Definitions and Implications

Q: How are combination products regulated?

They are regulated by the FDA under specific guidelines outlined in Title 21 of the CFR.

Q: Can I use a combination product without consulting a lawyer?

While some aspects can be managed independently, consulting a legal professional is advisable for compliance and regulatory issues.

Definition & Meaning

A combination product is a type of product that includes two or more regulated components, such as drugs, devices, or biologics. These components can be combined in various ways to function as a single entity. The definition encompasses several forms:

Products that are physically or chemically mixed, such as a drug-device combination.
Separate products packaged together, like a device and a biologic.
Individually packaged products intended to be used together, where both are necessary for the intended effect.
Investigational products that are packaged separately but are meant to be used in conjunction with another investigational product.

Table of content

Legal Use & context

Combination products are relevant in various legal contexts, particularly in regulatory compliance and product approval processes. They fall under the jurisdiction of the Food and Drug Administration (FDA) and are subject to specific regulations that govern their safety and efficacy. Legal professionals may encounter combination products in areas such as:

Healthcare law
Pharmaceutical law
Regulatory compliance

Users can manage certain aspects of combination product compliance and documentation using legal templates available through US Legal Forms.

Key legal elements

Real-world examples

Here are a couple of examples of abatement:

Here are a couple of examples of combination products:

A pre-filled syringe that contains a biologic drug and a delivery device (hypothetical example).
A wound dressing that incorporates a drug to promote healing and serves as a physical barrier (hypothetical example).

Relevant laws & statutes

The primary regulation governing combination products is found in Title 21 of the Code of Federal Regulations (CFR), specifically:

21 CFR Part 3 - Definitions and Procedures for Combination Products

Comparison with related terms

Term	Description	Difference
Drug	A substance used to diagnose, cure, or prevent disease.	Combination products include drugs but also involve devices or biologics.
Device	An instrument or apparatus for medical purposes.	Combination products may integrate devices with drugs or biologics.
Biologic	A product derived from living organisms for medical use.	Combination products can include biologics alongside drugs or devices.

Common misunderstandings

What to do if this term applies to you

If you are involved with a combination product, consider the following steps:

Review the relevant regulations to ensure compliance with FDA requirements.
Consult legal professionals for guidance on navigating the complexities of combination products.
Explore US Legal Forms for templates that can assist in documenting and managing compliance.

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Quick facts

Attribute	Details
Regulating Body	Food and Drug Administration (FDA)
Key Regulation	21 CFR Part 3
Examples	Pre-filled syringes, drug-eluting stents

Key takeaways

Frequently asked questions

What is a combination product?

A combination product is a product that combines two or more regulated components, such as drugs, devices, or biologics.