The US Food and Drug Administration (FDA) has proposed classifying three types of medical device products into its Class II regulatory controls scheme, subjecting them to special controls meant to ensure their efficacy, safety and quality.
Background
In the US, medical devices are regulated by FDA's Center for Devices and Radiological Health (CDRH) and subject to three general classifications: Class I (for low-risk devices), Class II (moderate risk) and Class III (high risk). While Class III devices almost always require the submission of a premarket application (PMA) and require prior approval, and Class I devices generally only require a company to notify FDA that a device is being marketed, Class II devices represent something of a compromise.
If FDA has set standards for a Class II device, sponsors must submit a premarket notification (usually referred to as a 510(k) application) certifying that the device meets both general controls to ensure device safety and efficacy andspecial controls meant to address the unique concerns of a specific type of device.
In return, FDA is able to grant marketing clearance to a device relatively quickly, avoiding the time-consuming PMA process, which generally takes a case-by-case approach to evaluating devices and requires the submission of clinical data.
New Class II Devices
This week, FDA released Federal Register notices indicating that three devices will soon be subject to Class II controls: Dengue Virus Serological Reagents, Pancreatic Drainage Stent and Delivery Systems, and Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens.
Only one of the device types, the nucleic acid-based systems, had previously been classified, and was formerly subject to Class III controls. FDA said its Microbiology Devices Panel had determined that the special controls were sufficient to provide "reasonable assurance of the safety and effectiveness" of the devices, and that Class III controls were no longer necessary after nearly 20 years on the market. FDA has already released a guidance document on the special controls for the device.
A second type of device, the dengue virus serological reagents, was originally slated for Class III as well, but FDA reversed its October 2010 decision after an appeal from InBios International, which had been seeking classification for its DENV Detect IgM Capture ELISA product through the De Novo process. FDA said that upon further reflection, it agreed that special controls are sufficient to mitigate the device's risks, which include false positive and false negative results. Those Class II controls are explained in a new guidance document.
A third device type, pancreatic drainage stent and delivery system, will also be subject to Class II controls after a similar appeal by Xlumena Inc over FDA's decision to classify its AXIOS Stent and Delivery System into Class III. Xlumena's appeal was successful, and FDA said Class II controls would be sufficient to protect the public. The Class II controls will be posted at 21 CFR 876.5015, FDA said.