The U.S. Food and Drug Administration (FDA) recently announced the formation of an interagency task force with the Centers for Medicare and Medicaid Services (CMS) to address issues relating to the regulation of laboratory-developed tests (LDTs). The announcement follows the issuance of draft guidance by FDA in October 2014 that provides a basic framework for increased oversight of LDTs. The draft guidance, “Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories,” sets the groundwork for the FDA to step up its oversight of LDTs. AGG prepared a bulletin on the FDA’s LDT guidance available here.

In 1976, when the agency first began regulating LDTs, the tests were mostly non-commercial, generally used FDA-approved components, and the test methods were generally well-established and performed by specialists with advanced training. Agency officials have expressed concern that the rules governing LDTs have not kept pace with developments in LDTs, as the volume and types of LTDs have grown significantly, they are often used as a mechanism for market entry of novel tests, and they are now being developed for broad commercial use, among other things.

Both CMS and FDA have regulatory authority over LDTs: FDA oversees the quality end, and CMS regulates labs through the Clinical Laboratory Improvement Amendments (CLIA). Each agency plays an important role in ensuring quality laboratory testing. The FDA categorizes tests based on their complexity, reviews requests for waivers, and develops rules and guidance for CLIA complexity categorization. CMS is responsible for issuing laboratory certificates, collecting user fees and conducting inspections and enforcing regulatory compliance. In addition, CMS handles approvals of private accreditation organizations for performing inspections, approvals of state exemptions, monitoring laboratory performance on proficiency testing (PT) and approvals of PT programs.

The FDA has the authority to regulate all laboratory tests under the authority of the 1976 amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA), and while LDTs are and have been subject to the FDA’s regulatory authority, the agency generally has exercised enforcement discretion in its approach to LDTs. In its recent guidance, FDA has proposed a framework for regulatory oversight of LDTs that will impose registration and listing requirements, medical device reporting requirements, and the imposition of premarket review requirements and quality system regulation requirements for certain LDTs. The FDA and CMS will work together to expand the collaborative effort to streamline the oversight process and work to build in quality control systems for LDTs that have been classified as moderate or high-risk LDTs.

The task force will focus primarily on three areas:

  1. Identifying areas of similarity between the FDA quality system regulation and requirements under CLIA; 
  2. Clarifying responsibilities for laboratories that fall under the purview of both agencies; and 
  3. Leveraging joint resources to avoid duplication and maximize efficiency.

In its guidance, FDA is proposing the following:

  1. Collect basic information on all LDTs through a new notification process;
  2. Use advisory committees to obtain input as to risk and priority for regulation; 
  3. Develop a phased-in regulatory framework over nine years using a risk-based approach in categorizing the LDTS, with higher risk LTDs being subject to greater regulatory authority; and 
  4. Continue limited enforcement discretion for specific categories determined by FDA to be in the best interests of the public.

FDA plans to continue exercising enforcement discretion for LDTs in the following categories:

  1. LDTs used solely for forensic purposes;
  2. LDTs used in CLIA-certified, high-complexity histocompatibility labs for transplantation; 
  3. Low-risk medical devices, including low-risk LDTs; 
  4. LDTs used for rare diseases; 
  5. “Traditional” LTDs (i.e., those that were developed and in use in 1976 when the FDA first began its oversight); 
  6. LDTs for unmet needs, when no FDA cleared/approved alternative exists.

The task force intends to help simplify regulatory approaches to make it easier for companies to bring LDTs to market and keep them compliant with regulations. FDA is inviting public comment on the proposal, and comments may be sent to LDTFramework@fda.hhs.gov.

No implementation will begin prior to publication of final guidance documents, expected to be released in the summer of 2015.