Tuesday, August 19, 2014

"Experimental" View of FDA LDT Categories and Timelines

Note: I am not certain whether all these categories and timelines are what the FDA intends in its guidance document... but here's an alternative presentation of most of the data as I understand it as of August 2014.

Time Zero:
Final Guidance (FG) Published

·   Forensic Tests (Never)
·   High Complexity HLA Diagnostics for Tissue Typing/Transplant (Never)
FG + 6 months
· “Notification” for All LDTs, but:
· “Registration and Listing” if Entity has IVDs –OR- if the entity has declined to use the simpler Notification option

· This date applies to: (1) LDTs previously on the market or (2) marketed before the 6 month date
· LDTs entering market: Notify FDA before clinical use.

FG + 12 months
· PMA for High Priority Enforcement: 
ü  Same intended use as an IVD companion diagnostic;
ü  Same intended use as any PMA Class III IVD;
ü  LDTs for safety/efficacy blood products (e.g. HIV tests)
·   No action except notification for:
ü  Class I LDTs,
ü  Traditional 1976 LDTs (Are you one?  If: Solely ASR components; One hospital/health system; Interpreted by laboratory professional);
ü  LDTs for rare diseases, but only within health systems;
ü  Unmet Need LDTs (Are you one?  No IVD, so keep monitoring that status; One Hospital/Health system; FDA waives the ASR rule)

·         Also at this date: Safe harbor for tests which are in the several high risk categories AND entered the market before the 1 year deadline AND the approval paperwork is under FDA review
·         NB:  No action but notification for those tests in the lower priority categories in later rows
FG + 1-5 years
· Development of priority list, likely to include:
ü  Devices that act like companion diagnostics, even if no IVD,
ü  Screening tests for serious diseases,
ü  Tests for high risk infectious disease,
ü  Other “priorities” TBD
ü  Likely the fact that FDA views LDTs [with RUO or manufactured components like chips or plates or designed by commercial labs or licensed by academia to companies] as “not true LDTs” will mean they are in earlier review categories, also
·   ?? Suppose you are a “screening test for serious disease” (enforce, left column) but also “unmet need” (don’t enforce, right column)…or other mixed rule categories.
FY 6+ years
· Roll out clearance/approval reviews to Class II (510k) LDTs
·   Unclear if and when exemption for “ASRs tests for hospitals for their own patients” stops applying

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