Combination
Products
Combination Products
Combination Product is a product composed of two or more regulated components such as drug/device, biologic/device, drug/biologic, or drug/device/biologic which can either be produced as a single entity, co-packaged or maybe separately packaged but all components are required to achieve the intended use.
- Post marketing safety reporting (PMSR) requirements (also referred as combination product PMSR final rule) was issued by the FDA in December 2016 as codified in 21 CFR Part 4, Subpart B
- PMSR regulations for drugs, devices, and biological products share many similarities and each set of regulations establishes distinct reporting requirements, including reporting triggers and timeframes.
To comply with these regulatory requirements, understanding about the combination products and how FDA regulates them, combination product PMSR final rule and an overview of which entities are subject to the final rule, applicable post marketing safety reporting requirements including the entities not covered by this rule is very crucial.
Drug Device Combination Products:
Medicinal products and medical devices that are placed on the market together are referred to as combination products or drug device combination (DDC) products. If the principle intended action is achieved by the medicine, the entire product is regulated under Directive 2001/83/EC or Regulation (EC) No 726/2004. These can be of two types:
a. Co-packaged DDC: the medicinal product and the device are separate items contained in the same pack
b. Integral DDC: Medicinal product with an integral medical device (new requirements under article 117 of the EU-MDR)
Combined Advanced Therapy Medicinal Products (ATMPs) are the products that meet the following requirements:
- Must incorporate one or more medical devices as an integral part of the product
- Its cellular or tissue part must contain viable cells or tissues
- Non-viable cells or tissues must be liable to act upon the human body with action that can be considered as primary to that of the devices
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