"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.

EVENT	TIME (FG +)	WHO IS IN	WHO IS NOT IN
1	Time Zero: Final Guidance (FG) Published		·   Forensic Tests (Never) ·   High Complexity HLA Diagnostics for Tissue Typing/Transplant (Never)
2	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.
3	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
4	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.
5	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