When the FDA releases a guidance to the industry, such as the 2015 Guidance on Reprocessing Medical Devices, it is often applicable to devices subject to clearance and approval in the future. However, in the 2015 Guidance on Reprocessing Medical Devices, enforcement focuses on both new and predicate devices.
A validation for a medical device with instructions for use (IFU) with cleaning instructions must validate to worst-case conditions. As a risk mitigation strategy, it is important that a device manufacturer with a family of products with cleaning instructions validated prior to 2015 consider cleaning validation studies to update a design master file (DMF).
Within the regulations, there is a high level of scrutiny regarding the IFU and comprehension of the cleaning instructions. A validation addresses worst case for device cleaning and the comprehension of the instructions by a third party. Alternatively, ahead of a validation, an efficacy study is a solution WuXi AppTec offers to evaluate the reproducibility and reliability of the cleaning instructions.
Working with our technical and regulatory experts, we look to support the product development and validation of the device. Our experts leverage their industry experience and the more than 1500 products we have validated.
We are more than happy to explore the best solution for you and your device. Contact us today for more information at email@example.com or 651-675-2000.