Patient Preference Information (PPI) guidance on when and what methods to use to collect and submit patient preference information (PPI) for a device to FDA.
FDA final guidance titled Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.
Law firm, Hogan Lovells, analyzes the changes to the updated enforcement policy and provide key takeaways for entities responsible for communication regarding approved/cleared medical products.
An analysis from the Life Sciences legal team at Hogan Lovells.
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.
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.
Chris Fourment, MD, Senior Vice President, Clinical Strategy at Iterative Health, who specializes in structuring clinical trial programs, discusses the new FDA guidance on decentralized clinical trials, and how DCTs can help spur health and research equity.
Recognizing that additive manufacturing is an emerging technology, the agency is providing an outline of its current thinking about the technical aspects of AM processes.