Objectives of the Presentation
The presentation explains the final guidance document and provides an implementation approach
Why Should you Attend
- Learn the definition of an accessory and parent device from the guidance document - they are not in any regulations
- Understand how the definition applies to "software as a medical device" SaMD
- Understand the three prong approach to application of the accessory definition
- Learn how to determine the classification status of an accessory
- Understand the two methods of change applicable to a classified accessory
- Understand the use of the de novo process for an unclassified accessory
On December 30, 2016, FDA-CDRH+CBER issued the final guidance document to describe accessories and, in certain cases, provide a classification pathway. This is an important guidance document because it helps resolve an area of controversy and confusion. Under the Food, Drug, and Cosmetics Act (FD&CA) an accessory to a device is itself a device. The Unique Device Identification (UDI) rule, illustrates the confusion. The preamble includes a response to a request to define a device accessory. The response was, "No other medical device regulation has defined 'accessory' and the final rule does not include any requirement that specifically applies only to an accessory to a device and does not distinguish between accessories and other devices in any way". This left many device manufacturers unclear about which products require a UDI and how to complete the GUDID entries.
The final guidance document offers three major points for the discussion. First, it describes what FDA considers as an accessory, including a definition. The guidance document couples the definition of an accessory with a three-prong performance determination: support, supplement, or augment a parent device. This determination includes examples to help guide the determination as well as examples of products FDA does not consider as an accessory.
Second, it explains how to apply the device risk class system to accessories. Third, it covers issues of classification and reclassification with particular emphasis on using the de novo process for accessories not already classified.
The presentation explains the approach in the guidance document and gives you the tools needed to determine and document whether any of your products are an accessory.
Who will Benefit
Determining whether a product is an accessory requires a team to cover the various aspects in making the determination. Team members include:
- Product Marketing Specialists
- Regulatory Affairs Specialists
- Device Quality Specialists
- Design Engineering Managers
- Production Managers
- Product Documentation Specialists
- Risk Management Specialists
Participants receive a worksheet to help apply the definitions and determine if the accessory is classified. Participants also receive a copy of the guidance document.