FDA Compliance

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Effective March 15: CMS Rule Regarding Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’

Published: February 8, 2021

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U.S. FDA Releases Artificial Intelligence and Machine Learning Action Plan

Published: January 18, 2021

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U.S. FDA Introduces Safer Technologies Program to Promote Safe, Early Access to Innovative Medical Devices

Published: January 12, 2021

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Two people discussing documents at a wooden table with a laptop and calculator.

Preparing for a Pre-Submission Meeting En Route to Regulatory Approval

Published: November 3, 2020

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FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin

Published: October 19, 2020

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Key Considerations for Executing Clinical Trials for Dual 510(k) and CLIA Waiver Applications

Published: August 11, 2020

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Clinical research specialist at microscope, symbolizing advanced medical testing expertise.

Stop Letting GLP Stunt Your Chemistry Studies

Published: June 11, 2020

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FDA Releases Final Guidance on Bone Anchor Premarket Notification 510(k) Submissions

Published: March 5, 2020

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The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval

Published: December 3, 2019

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FDA Issues New Draft Guidance Document for Pre-Submissions

Published: June 11, 2018

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Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings

Published: January 23, 2018

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The Importance of Human Factors & Usability Engineering in Medical Devices

Published: October 9, 2017

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Utilizing Biological Risk Assessments and Chemical Characterization to Reduce Medical Device Development Timelines

Published: September 27, 2017

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