Author: Dorothy Wilkerson - Regulatory Affairs Manager

In order to help Suppliers and their Customers (Medical Device Manufacturers) categorize a medical product, it is important to distinguish the potential product categories and then collect integral information to properly categorize and understand any necessary next steps. 

Globally, there are some differences in the category types recognized by the various regulatory bodies.  Below is a list of the potential medical products categories and their global relevancy: 

• Medical Component/Raw Material (Global) 

• Contracted Finished Device (United States Only) 

• Medical Device (Global) 

In order to determine the product category, the following types of information must be collected: 

• The product’s labeling/literature. 

• The intended use applications claimed for the medical product, if any. 

• Fate of the medical product at the medical device manufacturer (Customer). Questions include but are not limited to: 

• Is the customer performing any further transformation/processing steps on the medical product? 

• Examples of transformation/further processing steps include: Cutting a tubing to length, Piercing, Punching, Bonding, Assembling, Joining, Cutting, Sewing, Soldering, Welding, Chamfering, Ink Marking, Engraving, Laser Trimming, Collar Sealing, etc. The following transformation/processing steps are not considered by the US FDA as transformation/processing steps that prevent the product from being potentially considered as a finished device: washing; disinfection; depyrogenation; packaging; labeling; sterilization; kitting. 

• Is the Customer incorporating the medical product into its medical device before the medical device is packaged/labeled/sterilized? 

• Is the Customer assembling the medical product to its medical device before the medical device is packaged/labeled/sterilized? 

All Suppliers of medical products should have some level of established quality management system procedures in place. However, any supplier that is manufacturing a product that would be categorized as a contracted finished device, on behalf of their customer, have additional quality and regulatory requirements that must be followed in the United States. 

Per US FDA Title 21 CFR Part 807: 

Supplier of Contracted Finished Devices, whether the Supplier is located in the US or outside the US must: 

• Register the Establishment with the FDA 

• List the device with the FDA 

• Will need the Customer (Medical Device Manufacturer) to provide information in order to show that the finished device may be marketed/sold. This includes the device’s 510(K) or PMA#, its Proprietary name, and the countries where it will be marketed/sold. 

• Pay FDA Fees 

• Comply with 21 CFR 820 Requirements 

• Execute a Contract or Quality Agreement with Contract Manufacturing Language with the Customer