Regulatory Affairs

FDA Guidance Outlines Rules for Site Change Supplements

Final guidance issued by the FDA on Friday outlines what devicemakers should know about manufacturing site changes and when they should submit supplements. Read More

FDA Issues Final Rule on Reclassification of Devices

The FDA issued a final rule streamlining its classification procedures for medical devices and allowing for changing classifications by administrative orders rather than the rulemaking process. Read More

Gottlieb Pledges Further Details About Precertification Program

FDA Commissioner Scott Gottlieb said the agency plans to release more details in the coming weeks about its precertification program for digital health technology, including details of the agency’s testing plan for products in 2019. Read More

FDA Finalizes Guidance on User Fees and Refunds for Device BLAs, PMAs

The FDA issued final guidance on user fees and refunds for device biologics license and premarket approval applications with just minor changes from the October 2017 draft. Read More

FDA Unveils Guidance on Diagnostic X-Ray Equipment

The FDA issued draft guidance to clarify radiation control regulations for diagnostic x-ray systems and their major components, including recordkeeping, reporting, manufacturing, importing and installation requirements for “electronic products.” Read More

House Committee Introduces Five-Year Medical Device Tax Delay

A tax relief package introduced in the House Ways and Means Committee last week would delay the medical device excise tax another five years. Read More

Canada Issues Guidance on Premarket Requirements for Cybersecurity

Health Canada released guidance for devicemakers on how to comply with premarket cybersecurity requirements. Read More

FDA Releases Proposed Rule on De Novo Pathway for Novel Devices

The FDA published a proposed rule that would further streamline the agency’s De Novo classification process. Read More

Medtronic Agrees to $51 Million Payout to Settle Three Claims

Medtronic agreed to make payments totaling $51 million to settle claims by the Department of Justice against Covidien and ev3, two firms it acquired in 2015. Read More

FDA Looks to Devices to Combat Opioid Crisis

CDRH has selected eight medical devices and digital health technologies as potential solutions to help combat the growing opioid crisis in the United States. Read More