Design Approval Requirements and Signatures: Navigating 21 CFR 820 and ISO 13485 Medical device manufacturers often struggle with a fundamental question: What signature requirements apply to design input and design output approvals? Understanding how 21 CFR 820 Design Controls and ISO 13485 address design approvals is essential for achieving both compliance and operational efficiency. This...Read More

Guidance Update: FDA revises Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The FDA released a revised draft of the Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program on 15 March, 2024. When finalized, this guidance will supersede both the current version of...Read More

New to medical device software?  Our partners Mike Russell and Ginny Kwan Gattinger will be presenting a Regulatory Affairs Professional Society (RAPS) webinar on Wednesday, May 17, 2023 at 1:00 pm EDT to discus the unique and amplified challenges with software development for SiMD and SaMD.  They will discuss approaches for addressing the challenges and...Read More

In September 2022, FDA Updated the Software Guidance Policy for Device Software Functions and Mobile Medical Applications.  Last revised in September 2019, the policy is intended to clarify FDA’s regulatory oversight on software functions, including those used on mobile platforms and general-purpose computing platforms as well as software in the function or control of a...Read More