Tag Archives: FDA guidance

510k Submission Planning

510k Submission Planning

By Joy Greidanus
510k Submission Planning

510(k) submissions have been a hot topic of late! Before you start your 510k submission make sure you’re aware of the pitfalls. Being responsible for writing and submitting a 510(k) can seem overwhelming – especially when tied to a scheduled product launch or marketing campaign driven by revenue goals. One of the most influential factors to a successful 510(k) submission is strategic planning.

Continue reading →

FDA Logo

FDA Updates Guidance on ISO 10993-1 for Evaluation of Biocompatibility  

By MedTech Intelligence Staff
FDA Logo

The FDA has updated its guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in pre-market applications.

Continue reading →