Excerpt from the Comments:
The proposed rule is essential to patient safety and recognizes the modern laboratory developed test (LDT) market.
Overall, U.S.PIRG supports this proposed rule to clarify and strengthen the agency’s enforcement role over laboratory-developed tests (LDTs). We have been advocating for changes in FDA oversight and enforcement of quality standards for the many LDTs used by health care professionals and sometimes by consumers themselves. We applaud the FDA for recognizing that health practices have changed over the four decades since the Medical Device Amendments of 1976 (the MDA) established FDA regulation of devices intended for human use. This proposed rule will clarify that LDTs are medical devices and will phase out FDA “enforcement discretion” – two important steps to regain FDA’s power to ensure safety and efficacy of all medical devices, including those developed and manufactured in laboratories.
Senior Director, Health Care Campaigns, U.S. PIRG Education Fund
Patricia directs the health care campaign work for U.S. PIRG and provides support to our state offices for state-based health initiatives. Her prior roles include senior policy advisor at NJ Health Care Quality Institute, associate state director at AARP New Jersey and consumer advocate at NJPIRG. She was appointed to the Ground Ambulance and Patient Billing Advisory Committee in 2022 and works with patient advocates across the U.S. Patricia enjoys walking along the Potomac River and sharing her love of books with friends and family around the world.