The FDA draft guidance included 30 device types, such as common urine and blood tests, alcohol breath tests, blood clotting protein tests and radiology device accessories, such as film cassettes, film processors and digitizers.
The agency said less stringent oversight of these devices would not compromise public health. But it intends to continue to enforce all other applicable requirements for the devices, including registration and listing and Good Manufacturing Practices.
Read the release on FDA exemptions.
Related Articles on FDA Oversight of Medical Devices:
Minnesota Lawmakers Blast FDA Medical Device Policy
FDA Pressed to Speed Up Device OKs Before Fee Reauthorization
Study: No Safety Benefit Recognized From Slower, Burdensome FDA Approval Process for Devices
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
