Synopsis : The benefits of Independent Verification and Validation (IV&V) of medical device software are many. The purpose of this paper is to discuss the value of Independent Verification and
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #13: Incomplete Software Requirements Documentation You provided Software Requirements Specification (SRS) documentation in
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #14: Inadequate Risk Management Information You provided Risk Management File documentation in your
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #15: Inadequate Information on the Confidentiality Controls used to Protect the Device You
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #16: Missing Cybersecurity Risk Assessment Documentation Based on the information provided in your
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #17: Lack of Documenting the Final Version Number of the Software and Firmware
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #18: Off-The-Shelf Software In your software description, you provided information about the OTS
Here’s this week’s example of an Additional Information Request (AI Request): FDA Additional Information Request – Example #19: Missing Adequate Information on the Availability Controls used to Protect the Device
Here’s this week’s example of an Additional Information Request (AI Request): Based on the information provided in your submission, your device meets the definition of a cyber device under Section
Here’s this week’s example of an Additional Information Request (AI Request): Your submission documentation indicates that you are using YYY as the operating system (OS) for the device. This OS
Here’s this week’s example of an Additional Information Request (AI Request): Based on the information provided, it is not clear how the device detects, monitors, logs, and/or alerts users of
