Q: We’ve run into a Design History File (DHF) problem. We’re considering buying an existing product to use in one of our medical devices. But the existing product never has been used for medical devices, so there’s no Design History File associated with it. What are your recommendations for this kind of situation?
A: A non-medical device, such as a TV, when combined with another medical device, becomes an accessory to that medical device. It doesn’t become a medical device itself – unless you alter its intended use to a medical application.
FDA’s DHF requirements are for the final medical device, including any accessory products. So your Design History File always should be based on the entire product you will market.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Sometimes you might discover that what you think is an accessory is actually a medical device with an existing classification.[/pullquote]
Sometimes you might discover that what you think is an accessory is actually a medical device with an existing classification – and perhaps the product was not previously marketed in the U.S. In that case, you’ll need to create a separate DHF for what you thought was an “accessory”. The exception would be if the product was designed prior to June 1, 1998, and no substantive design changes have occurred since then.
Your DHF can be based on both retrospective as well as concurrent data. Your design plan should state the medical device is being re-designed for the U.S. market and explain what that re-design entails — even if it’s only to perform verification analysis against design input requirements and a design validation to prove the device performs and functions as described in those requirements.
There are some seemingly non-medical device products that actually are classified as medical devices because they are common accessories and have been classified along with a primary device. In recent years, FDA has been separately classifying accessories (usually as Class I exempt devices, thus not requiring DHFs) within the overall classification. As an example, see some of the gastric-type endoscopes.
Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services, 18 years as an FDA investigator and co-developer of FDA’s Quality Systems Inspection Technique (QSIT), and lead instructor of EduQuest’s Design Control for Medical Devices training class.