On July 31, 2014, FDA provided Congress advance copies of two proposed guidance documents regarding Laboratory Developed Tests (LDTs), which the Agency had planned to issue 60 days later.  The first is titled FDA Notification and Medical Device Reporting for Laboratory Developed Tests; the second is Framework for Regulatory Oversight of Laboratory Developed Tests.  (A copy of the two proposed guidance documents can be found at the following link.)

FDA was required to provide advance notice to Congress for these guidance documents under Section 1143 of the Food and Drug Administration Safety and Innovation Act of 2012.  Both documents generally reiterate the risk-based approach to regulation of LDTs that FDA articulated in previous communications.  However, the Agency has now provided specific compliance deadlines for this class of products.

As background, since the passage of the 1976 Medical Device Amendments, FDA has generally exercised enforcement discretion and thus not actively regulated LDTs, a class of in vitro diagnostics (IVDs) that are often manufactured, validated, and used within a single laboratory.  In the proposed guidance documents, the Agency announced that it will phase-in the regulatory requirements for these products over the next four to nine years, depending on the type of LDT.

Some of the key provisions in the two proposed guidance documents include the following:

FDA reasserted that it has equal jurisdiction over both IVDs made by device companies and those made by labs.  In particular, the Agency wrote:  “[a]n IVD . . . meets the device definition irrespective of where and by whom it is manufactured.” FDA also explicitly stated that LDTs developed at academic medical centers will not be treated any differently, although this is listed as a factor for consideration for certain types (“Traditional LDTs,” for example). For LDTs already on the market when the guidance is finalized, grace periods for premarket submissions will be allowed, but not for new LDTs introduced after that time. FDA elected to forego requiring registration and listing in exchange for notification and Medical Device Reporting.  Presumably, this also means that there will be no routine inspections of labs that comply with notification requirements, at least for the near term. FDA will allow CLIA-certified labs currently marketing tests that do not meet the definition of an LDT to fall within the same risk-based framework as “true” LDTs.

The two proposed guidance documents represent a significant step toward FDA regulating LTDs actively.  As proposed, FDA’s phased, risk-based approach will increase the need for labs, medical device companies, and pharmaceutical companies to plan their development programs strategically from an early stage.  For example, FDA indicated that it intends to exercise enforcement discretion with respect to premarket review and Quality System Regulation requirements for LDTs for unmet needs, but not for devices that act like companion diagnostics.  Consequently, to take advantage of that enforcement discretion, a lab will need to research and forecast whether a medical device is likely to be cleared or approved for its LDT’s use.  The lab will also have to anticipate whether an LDT that the lab has developed or is developing may subsequently be at risk for FDA enforcement because a drug that can be used safely and effectively only in conjunction with the lab’s test is later approved.  Similarly, a pharmaceutical company developing a drug that potentially might be safe and effective only in a population identifiable by an IVD may not safely assume that a lab will quickly and inexpensively develop that IVD.  How the company characterizes and develops the drug may dictate whether the drug’s approval will depend on FDA approval or clearance of a companion diagnostic.

For more information about the proposed guidance documents or about crafting and submitting effective comments to FDA on those documents, please contact the authors or the Hogan Lovells lawyer with whom you work.