Combination products, by their very nature, are harder for the FDA to regulate than singular products. The former can be any type of manufactured goods that falls under the specific FDA guidelines and includes some combination of drugs, biologics, and medical devices. Since the FDA has created a more streamlined way to regulate these products, attempting to obtain a jurisdictional designation for combination products is the first step manufacturers should take toward meeting this regulation.
Why is Jurisdictional Designation Necessary?
It is helpful for manufacturers to know which jurisdiction is taking over the regulation and research of its product. This allows manufacturers to understand more about the aspect of the particular product that is considered primary, the regulations it will need to stand up to, and a number of other pieces of information that will make it easier for manufacturers to comply with regulations.
There are three main jurisdictional designations for combination products. The part of the product the FDA deems primary is that which will determine which jurisdiction it falls under.
The three centers include:
- The Center for Drug Evaluation and Research (CDER), where the primary function is related to the drug included in the product
- The Center for Devices and Radiological Health (CDRH), where the primary function is related to the device included
- The Center for Biologics Evaluation and Research (CBER), where the primary function is related to the biologics included
The lead agency is the center that is chosen, while another may possibly be consulted in order to meet overall regulations. However, in some cases, it is difficult for the FDA to determine which (if any) function is primary. When this occurs, the product is assigned to whichever agency has the most experience dealing with similar products.
How Can You Obtain Your Product’s Jurisdictional Designation?
As stated by the FDA, it is the manufacturer’s responsibility to obtain the correct jurisdictional designation for their particular product.
The manufacturer must submit an official Request for Designation. This request must be 15 pages or fewer, and all the information it requires is listed as part of the FDA’s regulations on combination products. As part of the request, the manufacturer is also able to make a suggestion to the FDA about which center should be the lead agency for their product.
Once a manufacturer makes the Request for Designation, the FDA has 60 days to reply. If they do not do so in the allotted time, the product is immediately filed under the center of the manufacturer’s request. However, the FDA has not yet taken longer to respond than this 60 day allotment.
The First Step of the Process
Obtaining a combination product’s jurisdictional designation is an important first step in the process of meeting all regulatory requirements for said product. Doing so can help you determine how it may be viewed as well as regulated and possibly even marketed. If you have any questions about acquiring this information, contact us.