How does FDA regulate combination products?

Combination products are assigned to a FDA center that will have primary jurisdiction for its premarket review and regulation. To resolve these types of questions, FDA’s regulations at 21 CFR Part 3 include an algorithm for determining center assignment.

What is a combination product and how are they regulated?

The current definition of a combination product, according to the Code of Federal Regulations (CFR), is a product that involves a medical device and/or a drug and/or a biologic — combining any two of these product categories, and sometimes even all three.

What is a drug device combination?

Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy.

Who regulates combination products?

FDA Office
The FDA Office of Combination Products (OCP) was established on Dec. 24, 2002, as required by SEC. 204 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The law gives the OCP broad responsibilities covering the regulatory life cycle of combination products.

What are the types of combination products?

The most common types of combination products are pulmonary inhalers (eg, dry powders or pressurized aerosols), injection systems (eg, pen injectors and auto-injectors), and infusion systems (eg, ambulatory syringe pumps delivering continuous subcutaneous drug delivery).

Who is responsible to classify medical devices?

Manufacturers are responsible for the correct qualification and classification of their products.

What is an example of a combination product?

Examples of combination products include prefilled syringes, pen injectors, auto-injectors, inhalers, transdermal pumps and patches, and kits containing drug administration devices or components (see Fig. Examples of combination products.

What are the drug categories?

7 Drug Categories

• (1) Central Nervous System (CNS) Depressants. CNS depressants slow down the operations of the brain and the body.
• (2) CNS Stimulants.
• (3) Hallucinogens.
• (4) Dissociative Anesthetics.
• (5) Narcotic Analgesics.
• (6) Inhalants.
• (7) Cannabis.

Are pre filled syringes combination products?

Glass syringes prefilled with drug or biological products are combination products under 21 CFR Part 3. Specifically, they meet the combination product definition under 21 CFR 3.2(e)(1). Combination products are assigned to a lead center based on the primary mode of action as defined in 21 CFR 3.2(m).

What is the combination of products and services?

The combination of a product and a service is a product-service hybrid. For example, the iPod and iTunes were a famous example of this approach. Yet, they were complementary hybrids – it was possible to use an iPod without iTunes and vice-versa.

What is the classification of medical devices?

General medical devices are divided into four risk categories Class I (lowest risk), Class IIa, Class IIb and Class III (highest risk). Factors such as the degree of invasiveness, the part of the body affected, duration of use, and whether or not the device is active help determine the classification.

How to regulate drug-device combination products?

There’s no definition of combination product in Europe so a product will either be regulated as a medicinal product or a medical device depending on its primary mode of action. So, the drug delivery systems is purely here to deliver the drug which will have the action on the patient. So primary intended purpose of this product is the drug action.

What does the Office of combination products do?

The Office of Combination Products develops regulations and guidance for combination products. The links at the left of this page provide more information about combination product regulations and guidance. Also provided is a link to the procedures that FDA follows for the intercenter review of products.

How are medical products classified by the FDA?

To classify medical products as drugs, devices, biological products or combination products and assign them to an FDA center for premarket review and regulation, where their classification or assignment is unclear or in dispute.

How are combination products defined in the EU?

Definition of combination products – EU Combination products are not defined, but is mentioned in the scope of the medical device regulation: • Device integrating a medicinal product • Medicinal product integrating a device • Devices intended to administer a medicinal product When presented as a single, integral unit, not reusable 15 15 Content