FDA Issues Revised Final Guidance Regarding Administrative Procedures for CLIA Categorization

By Allyson B. Mullen –

On March 12, 2014, FDA issues a revised version of the Guidance Document “Administrative Procedures for CLIA Categorization” (the “2014 Guidance”).  FDA, Guidance for Industry and FDA Staff, Administrative Procedures for CLIA Categorization (March 2014).  The 2014 Guidance replaces the final guidance with the same name originally issued on May 7, 2008.  73 Fed. Reg. 25752 (May 7, 2008).  The 2014 Guidance has been revised to include information regarding FDA’s current administrative processes, including CDRH’s eCopy and the 510(k) Refuse to Accept policies.  2014 Guidance at 5.  In addition, the 2014 Guidance breaks down the procedures for determination of CLIA Categorization by in vitro diagnostic (IVD) devices under premarket review and other legally marketed IVD devices (e.g., tests exempt from premarket notification).  Id. at 5-6.  Perhaps most importantly, the 2014 Guidance provides timelines for FDA.  In the past, CLIA categorization tended to languish. 

For IVD devices undergoing premarket review (e.g., 510(k) or PMA), FDA will automatically create a CLIA tracking number (a CLIA Record “CR” number), which is separate from the premarket application number (e.g., 510(k) “K” or PMA “P” number).  Id. at 5. FDA will notify the sponsor of both the CLIA Record number and the premarket submission number.  The process by which FDA will determine test complexity will not change.  FDA aims to notify applicants of the CLIA categorization of the IVD device within two weeks following a positive marketing application decision (e.g., a substantial equivalence letter for a 510(k) or a PMA approval decision).  Id. at 5-6. 

For IVD devices that do not undergo premarket review, applicants should submit a request for CLIA categorization to the CDRH Document Control Center.  Id. at 6.  Although not required, FDA strongly encourages that applicants provide an eCopy of such CLIA categorization requests to expedite the review.  FDA will assign CLIA categorization requests a CLIA record number for tracking purposes.  FDA will attempt to notify sponsors of the CLIA categorization within thirty (30) days of the request.  Id. 

FDA maintains a searchable database of CLIA categorizations.  If an applicant changes the name of its tests or if the manufacturer or distributor changes, FDA recommends that a new request for CLIA categorization be submitted with the revised labeling to ensure that the record of the test in the public database is accurate.  Id.  Companies should be aware that this seemingly innocuous step could prompt a more substantive review.

If an applicant is submitting an application for a CLIA Waiver for a moderate complexity test, FDA strongly encourages providing an eCopy of such CLIA Waiver application to expedite the review.  CLIA Waiver applications are not accepted for devices that are under premarket review at the time of the submission, unless the application references a Pre-Submission during which agreement was reached for a Dual 510(k) and CLIA Waiver application strategy.  Such Dual submission should contain the full 510(k) and CLIA Waiver application in a single submission.  The Dual submissions will be subject to the 510(k) Refuse to Accept Policy.  The 2014 Guidance also sets forth current performance goals for CLIA Waiver applications:

    1 This performance goal applies to both the CLIA Waiver application and the 510(k).

Per the 2014 Guidance, a Substantive Interaction may include “a request for Additional Information (via letter or email), a notification that review will Proceed Interactively (via email), or notification of Waiver Granted (via formal letter).”  A MDUFA Decision may include “a notification of Waiver Granted (via formal letter), notification of Waiver Denial (via formal letter), or withdrawal by the sponsor.”  Id. at 7-8.

Lastly, for additional information regarding CLIA Waiver applications, the 2014 Guidance suggests referring to the Guidance Document “Recommendations for Clinical Laboratory Improvement Amendments of 1998 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.”  Further, applicants can seek feedback from FDA prior to submitting a CLIA Waiver application or conducting studies in support of such an application through the Pre-Submission program (see our earlier post on the Pre-Submission program).  Overall, we think this updated guidance document will be a useful reference for understanding the administrative process for seeking CLIA Categorization or Waiver, and understanding the new, more predictable timeframes.