FDA’s 2016 Guidance Plans Include LDTs and Other Diagnostics Topics

In a series of three recent FDA Voice blog articles, the U.S. Food and Drug Administration (FDA) surveyed its accomplishments in 2015 and detailed its 2016 agenda. The FDA also separately issued its annual list of guidance documents that it plans to finalize in 2016. Both of these releases address issues of importance for clinical laboratories and the diagnostics industry.

The first FDA Voice blog focused on medical product innovation, noting “unprecedented innovation in the sectors we regulate” and the agency touted a 36% drop in the agency’s average time to decide on premarket approval applications since 2009. A word of advice was also shared, recommending drug and device makers engage in conversations with the FDA “at the early stages of development” to weed out products that are likely to fail. In that blog, Stephen M. Ostroff, M.D., acting commissioner of Food and Drugs addressed next generation sequencing tests and the agency’s efforts to facilitate development of new technologies and achieve more precise diagnosis using “state of the art diagnostics”—including the launch of its precisionFDA web platform that allows stakeholders to “come together” to further this technology.

In the annual report listing guidance documents to be issued in 2016, the agency predicts it will finalize its framework for regulatory oversight of laboratory developed tests (LDTs). LDT guidance was listed on the “A-list” as a prioritized guidance document intended to be published during 2016. The A-list also includes draft guidance regarding companion diagnostics co-development.

The B-list, for documents the agency intends to issue as “resources permit,” includes blood glucose monitoring test systems for prescription point-of-care use and self-monitoring blood glucose meters for over-the-counter use. Dual 510(k) and Clinical Laboratory Improvement Amendments Act (CLIA) Waiver by application also appears on the B-List.

Previously issued guidance documents the Agency lists for retrospective review in 2016 include:

• Review Criteria for In Vitro Diagnostic Devices that Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations

• Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate Nursery

• Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices

• Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable

Takeaway: The FDA once again reiterates its commitment to finalize LDT guidance this year.