FDA Announces Release of “Playbook for Threat Modeling Medical Devices”
Published: December 3, 2021
View
FDA Releases Draft Guidance: Content of Premarket Submissions for Device Software Functions
Published: November 3, 2021
View
FDA Breakthrough Devices and Safer Technologies Programs: Advantages for Patients and Medical Device Manufacturers
Published: June 7, 2021
View
What to Ask Before Submitting Your Medical Device for Approval
Published: June 7, 2021
View
Packaging Pitfalls Medical Device Manufacturers Cannot Ignore
Published: May 13, 2021
View
FDA Qualifies New Cybersecurity Medical Device Development Tool
Published: April 28, 2021
View
Effective March 15: CMS Rule Regarding Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’
Published: February 8, 2021
View
U.S. FDA Releases Artificial Intelligence and Machine Learning Action Plan
Published: January 18, 2021
View
U.S. FDA Introduces Safer Technologies Program to Promote Safe, Early Access to Innovative Medical Devices
Published: January 12, 2021
View
Preparing for a Pre-Submission Meeting En Route to Regulatory Approval
Published: November 3, 2020
View
FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin
Published: October 19, 2020
View
Key Considerations for Executing Clinical Trials for Dual 510(k) and CLIA Waiver Applications
Published: August 11, 2020
View
Stop Letting GLP Stunt Your Chemistry Studies
Published: June 11, 2020
View
FDA Releases Final Guidance on Bone Anchor Premarket Notification 510(k) Submissions
Published: March 5, 2020
View
The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval
Published: December 3, 2019
View
FDA Issues New Draft Guidance Document for Pre-Submissions
Published: June 11, 2018
View
