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The goal of this survey is to assess at a high level your laboratory's FDA LDT foundation to deliver a high level gap assessment to be used for planning purposes only.

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* 1. How many LDTs does your laboratory currently offer?
Pls list number total individual LDT tests offered. (estimate).

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* 2. What is your laboratory's 2023 annual test volume for LDTs?

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* 3. Please list the top 3 LDTs your laboratory offers by name, annual volume .

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* 4. Does your laboratory have a QMS ISO 13485 in place?

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* 5. Are any of your LDTs NYS approved?

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* 6. If yes, pls list NYS approved LDT's

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* 7. Have you completed a Clinical Validation FDA Gap Assessment ?

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* 8. Are you using any "research use only" reagents in any of your LDT's?

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* 9. What do you feel are your immediate FDA ruling needs.? You can check more than one.

Momentum Consulting is happy to discuss your results "live" and develop an LDT transition action plan with one of our subject matter experts. Pls book a zoom call using the link below:
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