Article 26 Nov 2025 FDA Issues First Draft Guidance In The Countdown To QMSR United States Healthcare
Article 05 Nov 2025 Current Opportunities And Challenges In RWE And Its Future With AI United States Healthcare
Article 05 Nov 2025 RWE And AI: Hand In Hand In The Future Of Regulatory Decision Making United States Healthcare
Article 27 Mar 2025 Medical Device Notification Warns Of Continued Data Integrity Concerns United States Healthcare
Article 11 Mar 2025 FDA Would Like To Join You In The Sandbox When Developing AI Enabled Devices United States Healthcare
Article 10 Feb 2025 AI May Make Your Device More Efficient, But Be Prepared To Spend More Time On Design Documentation United States Healthcare
Article 20 Dec 2024 FDA's Third Party Review Program Is Ready For The Next Pandemic, Not The LDT Final Rule United States Healthcare
Article 22 Nov 2024 New Draft Guidance Provides Detailed (And Burdensome) Recommendations For Chemical Assessments To Support Medical Device Biocompatibility United States Healthcare
Article 25 Mar 2024 Feeling The Heat (Or Cold) – New Draft Guidance Addresses Requirements For Devices That Produce Thermal Effects United States Healthcare
Article 19 Feb 2024 FDA Releases Final Guidance On Use Of Digital Health Technologies For Remote Data Acquisition In Clinical Investigations United States Healthcare
Article 07 Nov 2023 Wearables, Sensors, And Apps Part 1 – Updates On FDA's PDUFA VII Goals For The Use Of Digital Health Technologies In Drug And Biological Product Development United States Healthcare
Article 07 Nov 2023 A Question 30 Years In The Making: Would A Final LDT Rule Withstand Judicial Scrutiny? United States Healthcare
Article 03 Nov 2023 Wearables, Sensors, And Apps Part 2 – Development And Qualification Of Digital Health Technologies In Drug And Biological Product Development United States Healthcare