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Medical Devices; Laboratory Developed Tests
Federal Register · Rule · May 6, 2024
See 88 FR 68006 at 68023-24. … (Response 24) FDA disagrees with this comment.
89 FR 37286Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 17, 2015
See also Response 24 regarding comments on “one general physical location.” … (See Response 22, Response 23, Response 24, and Response 25.)
80 FR 55908Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 8, 2001
) $698/ $2,004 (5%) (d) Packaging—Validation $1,296 (95%) $1,296 (95%) $544 (95%) $544 (100%) $544 (100%) (f) Return to inventory—Procedures - - $299/ $471 (23%) $0/$399 … The estimated patient cost per cycle ranges from $8,000 to $10,000 (Refs. 24 to 26).
66 FR 1508Health and Human Services DepartmentFood and Drug Administration
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