The U.S. Food & Drug Administration may relax premarket notification requirements for certain in vitro diagnostic and radiology devices, according to a draft guidance issued by the agency this week.
The draft guidance lists 30 different device types that the FDA intends to exclude from 510(k) requirements, including common urine and blood tests, alcohol breath tests, blood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 safety and effectiveness of these devices have been well demonstrated over the years,” said Dr. Jeffrey Shuren director of the FDA’s Center for Devices & Radiological Health. “By addressing the risk level of these devices, the agency is taking a smart regulatory approach that eases unnecessary requirements for manufacturers, while making sure the public has safe and effective devices.”
Health Benefit Consultants, Share Your Expert Insights in Our Survey
MassDevice Staff Website The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
The agency intends to reclassify the devices and amend certain classification regulations to make the exemption official.
In the meantime, the FDA will use its discretion on whether to enforce 510(k) requirements for these devices, given that “they do not exceed the limitations on exemption specified in the device classification regulations.”
“FDA intends to continue to enforce all other applicable requirements, including, but not limited to, registration and listing and Good Manufacturing Practices as set forth in the Quality System regulations,” agency officials said in the release.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The guidance comes on the heels of the agency’s softened tone in regard to proposed 510(k) changes that has had the med-tech industry in a tizzy.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
