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
Devices News
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The FDA issued draft guidance to clarify radiation control regulations for diagnostic x-ray systems and their major components, including recordkeeping, reporting, manufacturing, importing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 pr... Read More
TGA Offers Guidance on Regulating Software as a Medical Device
Australia’s Therapeutic Goods Administration is reviewing how it regulates software as a medical device (SaMD) and has issued guidance on its latest thinking. 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
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
