Drug/device combinations, regulation

Leppard, S. Regulation of drug-device combination products in Europe. In Drug-Device Combination Products. Delivery Technologies and Applications-, Lewis, A., Ed. Woodhead Publishing Limited and CRC Press LLC Boca Raton, FL, 2010 pp. 464-495. 

A device (e.g., machine or equipment) marketed to the user, pharmacy, or licensed practitioner that produces a drug will be regulated as a device or combination product by CDER. This does not include equipment marketed to a registered drug manufacturer. 

A device containing a drug substance as a component with the primary purpose of the combination being to fulfill a device function is a combination product and will be regulated as a device by CDRH. 

A device that serves as a container for a drug or a device that is a drug delivery system attached to the drug container where the drug is present in the container is a combination product that will be regulated as a drug by CDER. 

A drug whose labeling or promotional materials makes reference to a specific device or generic class of devices ordinarily remains a drug regulated by CDER. It may, however, also be subject to the combination products regulation. 

A new trend in the delivery of medicines is to employ a device component. This may be an implantable pump for insulin, a metallic stent coated with a drug, or unit capable of rapidly vaporizing a discrete dose for inhalation. Such products are regulated by the FDA as "combination" products and may be reviewed by multiple Centers within the Agency, which may require additional levels of documentation to support the product design. 

Health Canada is the responsible Ministry for the enforcement of the Food and Drugs Act and for the formulation of and amendments to the Drugs Regulations. The former Drugs Directorate and the Medical Devices Bureau of the Health Protection Branch (HPB) have been combined to form a new agency, the Therapeutic Products Programme (TPP). 

Combination products A combination product is a product consisting of two or more regulated components (drug/biologic/device, etc.) that are combined as a single entity or is a product labeled for use with a separate device or biologic where both are required to achieve the intended use. 

The multichambered autoinjector is simply a device that will allow a nerve agent victim to administer both the atropine and the 2-PAM through a single needle. This medical device is also FDA-regulated and while each of the drugs contained in the device is approved separately, the combination delivery system requires additional FDA testing. Both of these products have spent at least a decade in development but are not expected to be fielded during the next several years. 

However, jurisdictional challenges (i.e. regulators turf battles) continue for various compounds and combination of drugs, biologies, and devices. For no biological reason, it has been agreed, for... 

---