FDA Reopens Oversight of Laboratory-Developed Tests Comment Period; Will Accept Comments Until September 15

By Jamie K. Wolszon –

FDA announced on August 19, 2010 in the Federal Register that the agency is reopening the comment period for comments related to FDA oversight of laboratory-developed tests ("LDTs"), and will now accept comments until September 15.  The comment period had closed August 15. 

LDTs are diagnostic tests developed and performed by a single laboratory.  They are widely used; virtually all genetic tests are LDTs, as are many tests for rare conditions and companion diagnostics.

Starting in 1992, FDA asserted that all LDTs are devices subject to regulation under the Federal Food, Drug, and Cosmetic Act.  Since then, the agency said it was exercising its enforcement discretion and not regulating LDTs.  Thus, the primary federal regulation of laboratories has been under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA").

Until recently, FDA has departed from this position of enforcement discretion in relatively few instances.  For example, FDA advanced its controversial and now-defunct proposal to regulate a subset of LDTs, known as In Vitro Diagnostic Multivariate Index Assays (“IVDMIAs”).  (IVDMIAs are tests where the results of multiple markers are combined to generate an “index score.”)  

We previously reported that FDA announced in June that it was revisiting its years-long policy of exercising enforcement discretion over LDTs, and considering adopting a risk-based framework.  The agency announced that it was holding the July 19-20 workshop as a first step to gather comment on the regulation of LDTs. 

As we previously reported, FDA officials at the July 19-20 workshop indicated that they planned to end the enforcement discretion approach, and more actively regulate LDTs, but that they had not decided on the details of a regulatory scheme.

FDA is reopening the comment period to “update comments and receive any new information,” according to the August 19, 2010 Federal Register notice.  Explaining its decision to reopen the comment period, FDA stated:  “Following publication of the June 17, 2010, notice, FDA received a request to allow interested persons additional time to comment.  The requester asserted that the initial time period was insufficient to respond fully to FDA’s specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues.”

The additional time also will provide interested parties with time to consider two preliminary reports regarding the 510(k) process and the use of science in the Center for Devices and Radiological Health (CDRH).  We previously reported that in early August, FDA unveiled preliminary reports from the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making.  To the extent that FDA decides to require a 510(k) for any LDT, changes to the 510(k) process can significantly affect the future regulation of LDTs.  The reopened comment period will provide an opportunity for interested parties to comment in more detail on FDA regulation of LDTs, and incorporate the preliminary recommendations regarding 510(k)s into those comments.