PLA deadlines for CY2018 are on January 12, April 11, July 12, and October 9. The PLA application portal is here (I believe you must be signed in to the AMA website itself to access that.)
Key parts of the application are currently:
- PMA, 510K, or Non FDA?
- Link for how providers can order the test.
- Terminology for the code.
- Disease; chemistry (RNA, DNA), number of markers, methods (e.g. qPCR), number of functional domains if indicated; specimen type; algorithmic result (e.g. if prognostic0, report type (e.g. risk score).
- Are any CPT codes currently used to report the test?
- Are existing codes "integral to" the test (e.g. do not report duplicatively).
- For what diagnoses does the test have clinical utility?
- Provide a clinical vignette (short template provided; a sentence or two).
- Provide a brief description of the service (short template provided; a couple sentences).
- Attach documentation via file upload.
- CLSI lab protocol.
- FDA insert if relevant.
- Copies of positive and negative reports
(Note that I have summarized the questions; see the full AMA website for the full questions). Authors can prepare their application via online forms and store and revise until it's ready to submit.
