The Food and Drug Administration (FDA) recently launched a new webpage that provides status updates on the agency’s 515 Program Initiative.1 The 515 Program is a process, pursuant to Section 515 of the Federal Food, Drug and Cosmetic Act, for reclassifying certain Class III device types to Class I or Class II.2 The new webpage lists each device type pending reclassification and notes which step in the reclassification process the agency has reached for that device. The page also lists the most recent Federal Register notice for each device type.

Device Classification and FDA’s 515 Program Initiative

Class I and II devices are generally considered to be lower risk than Class III devices and require clearance through the FDA’s premarket notification process.3 Class III devices, however, are typically higher risk or first-of-a-kind and require approval through a premarket approval application (PMA), which is a more onerous process than the premarket notification process. When the FDA’s device regulation program began, the agency regulated more than 100 Class III devices through the premarket notification process, with the intent that the FDA would eventually reclassify those devices (to Class I or II), or sustain the Class III classification and require PMAs; however, as of 2009, twenty-six medical device types remained in the transitional state, awaiting final classification. The FDA implemented the 515 Program Initiative in 2009 to facilitate final reclassification of the remaining Class III device types.

The recently launched webpage allows interested parties to check on the reclassification status of the pending device types. Specifically, the reclassification process involves five steps:

  1. Collect Existing Information: First, the FDA gathers information about the device type available in the public domain. Typically, the FDA collects information by issuing a Federal Register notice calling for the public to submit any known relevant information on the medical device type under consideration. The FDA may also choose to solicit information by convening an advisory panel meeting of scientific experts who will discuss evidence on the device type’s safety and effectiveness. Members of the public also have the opportunity to present information at advisory panel meetings. The FDA notes on its website that it reserves advisory panels for only the “most complex” cases where public discussion would assist the agency in its decision.4  
  2. Assess Risks and Benefits: Second, the FDA conducts a scientific analysis of the available safety and effectiveness information for the device type. The agency forms an expert team to conduct the analysis, usually consisting of an engineer, physician, life scientist and/or other specialists who will evaluate whether the device remain in Class III or should be reclassified to Class I or II.  
  3. Propose Classification: After its initial analysis, the FDA will issue a Federal Register notice proposing the regulation of the device type into Class I, II or III (also know as a proposed rule). The proposed rule will also invite public comment on the suggested classification.  
  4. Receive and Review Comments: The FDA will review the public comments that were submitted in response to the proposed rule. The agency may choose at this stage to make changes to the classification based on the comments that are submitted.  
  5. Render Final Decision: The FDA will issue a final decision, or final rule, on reclassification for the device type in the Federal Register.5  

What This Means

The new webpage is helpful for medical device manufacturers whose products currently fall under Class III but are subject to potential reclassification.6 Device manufacturers in this situation might eventually have to submit PMAs for their products if the FDA determines that the device type should remain in Class III. The new webpage serves as a helpful planning tool, because it shows manufacturers where they stand in the process. In addition, manufacturers who track the process may choose to take advantage of public comment opportunities that will be available once the agency issues a proposed rule on reclassification.