FDA Finalizes Guidance on Device Classification Procedures
Posted 12 April 2013 | By
The US Food and Drug Administration (FDA) has released a new guidance document finalizing its recommendations for the medical device industry on how to use Classification Product Codes (CPC), a critical aspect of the agency's system for keeping track of devices and making regulatory judgments about the approval processes for devices.
The CPC is widely used by FDA's device regulators, including those with the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
FDA's explains in the guidance, Medical Device Classification Product Codes, that the codes were originally created by the 1976 Medical Device Amendments-the legislation that granted FDA the authority to regulate medical devices-"to assist in accurate identification and tracking of current medical devices and to allow for tracking of and easy reference to predicate device types."
Those codes are still used to obtain "quality and reliable data" that helps regulators to perform analyses, and form the backbone of all its medical device databases. For regulatory purposes, they are used to indicate subgroups within product areas and classifications, and are frequently used to categorize unclassified or high-risk (Class III) medical devices, which may require stronger labeling or evidence requirements. In addition, FDA uses such codes to track adverse events, which can often times affect an entire class of products.
The CPC consists of a three-letter combination identifying the device type and its therapeutic purpose. "Classification product codes and information associated with these devices, such as names and attributes, are assigned by CDRH to support their regulation," FDA adds.
For example, a biopsy needle guide kit used as part of an ultrasonic pulsed echo imaging system is code OIJ, while a biopsy needle kit used in a gastroenterology-urology biopsy instrument is code FCG.
These codes are both assigned and maintained by the agency. However, the sponsor of the product application is charged with initially selecting the code, which is later verified by FDA for accuracy. The codes also largely determine which review panels (often used for novel devices utilizing a premarket application) will review the product.
Products that reference others, such as products undergoing the 510(k) premarket notification process, which requires that a device show its similarity to a predicate device, will in most cases assume the product code of that predicate. Some product codes may change or be entirely removed as medical technologies evolve, FDA said.
However, in the majority of cases, "A device will be assigned an existing classification product code when it has the same intended use, indications for use, and relies on technology that does not raise new safety and effectiveness questions."
Not substantially equivalent (NSE) devices should be assigned a different product code than the predicate device for which the 510(k) was originally seeking clearance, FDA explained.
For Investigational Device Exemptions (IDEs), CPCs "may be assigned" to a medical device if it falls into an established product code area, but this code is primarily used for FDA's own purposes and stands to differ from the one ultimately assigned to the product.
All companies may obtain FDA's assessment of their medical device under a 513(g) Request for Classification submission. The agency is required to respond to such a request with the agency's assessment of the device's generic classification, the class of device and which submission type is necessary to obtain approval.
FDA notes that it is also "common practice" for adverse event reports to indicate the product code of the device when submitting a 3500A adverse event report, otherwise known as medical device reports (MDRs).
"To improve the quality of MDRs, we recommend that reporters include the premarket submission number (if applicable) in section G5 of the 3500A form to further link the device to its original classification," FDA wrote.
The codes are also an integral part of the import, export and recall processes, and FDA's guidance makes recommendations as the CPCs respective inclusion in each.