APHL is sharing the perspective of public health laboratories with the Food and Drug Administration (FDA) and other organizations proposing frameworks to regulate laboratory-developed tests (LDTs). While APHL strongly supports accurate, quality testing, certain requirements, such as premarket review, could prevent public health laboratories from responding effectively to public health threats.
FDA’s Proposal to Regulate LDTs
In July 2014, FDA released draft guidance on the oversight of LDTs. The proposed framework would regulate LDTs in a risk-based approach, similar to the way medical devices are regulated. Due to growing concerns about tests lacking clinical validity, FDA is proposing premarket review requirements for LDTs and establishment of a quality system to assure that tests are safe and effective.
Laboratories that manufacture or utilize LDTs will be required to notify FDA of their LDT inventory six months after the date of the published final rule. This will allow FDA to classify LDTs into risk categories. The requirement to establish the test’s clinical validity through premarket review will depend on LDT placement within these categories. While every laboratory will be required to comply with notification and medical adverse reporting, only high risk Class III LDTs and moderate risk Class II LDTs will be subject to premarket review requirements. Class I LDTs will be allowed enforcement discretion with respect to premarket review.
APHL has submitted a
written comment to FDA giving constructive suggestions to ease the burden on public health laboratories while still maintaining quality and accurate testing standards. APHL members and staff also have participated in a public meeting and engaged FDA leadership in multiple forums, including the APHL 2015 Annual Meeting where Dr. Alberto Gutierrez, FDA’s director of the Office of In Vitro Diagnostics and Radiological Health, was a featured speaker.
In addition, APHL has responded to alternative proposals that aim to address issues with LDTs through modernization of the Clinical Laboratory Improvement Amendments (CLIA). Although the association is not endorsing a particular CLIA modernization proposal, it has contributed public health principles to several proposals and is currently drafting a position statement outlining principles to be included in any regulatory or legislative proposal.
For more information, contact Celia Hagan, senior specialist, Public Policy, 240.485.2758,