Regulatory Affairs

ARTICLES

China’s New Device Catalog Makes Significant Classification Changes

Medical device manufacturers with products in China should check their current product portfolios against a new device catalog released by China’s Food and Drug Administration to develop transitional plans if any of their devices will be reclassified. Read More

FDA to Launch PMA Pilot Program This Month

The FDA is preparing its new Premarket Approval Application Critical to Quality pilot program, created to give PMA applicants the option to speak with the FDA on development of CtQ controls for… Read More

FDA Guidance Aims to Improve Demographic Data for Devices

The FDA released guidance to help the medical device industry analyze and report clinical study data on age, racial and ethnic subgroups, noting there is… Read More

FDA Seeks Ideas for Regulations to Cut Under Trump Policy

The FDA is asking stakeholders for help identifying federal requirements that can be repealed or replaced under the Trump administration’s deregulatory push. Read More

FDA Seeks Entrepreneurs to Join Digital Health Team

CDRH is looking for entrepreneurs to help the agency create digital health regulations. Read More

FDA Releases Final Guidance on Interoperable Devices

The FDA unveiled final recommendations for how medical devices should be designed to interact with other devices and IT systems. Read More

EU Notified Body Extends Deadline for MEDDEV Rev. 4 Implementation

European notified body TÜV SÜD said it will extend the implementation date for the MEDDEV 2.7/1 Rev. 4 guideline on clinical evaluations for device manufacturers and notified bodies. Read More

Australia Issues Update on Medical Device Reform

Australia’s Therapeutic Goods Administration released a status report on regulatory reforms for medical devices, including upcoming changes. Read More

FDA to Accept IEC Standards in 510(k) Submissions for Diathermy Devices

The FDA issued draft guidance on compliance policies for 510(k) submissions for ultrasonic diathermy devices. Read More

FDA Issues Guidance on Real-World Evidence

The FDA finalized guidance on the use of real-world evidence to support the agency’s regulatory decisions on medical devices. Read More