State filing guide
CLIA waiver application and requirements in Maryland.
Ask about my application — no payment todayMaryland requires a state permit or Letter of Exception as well as CLIA authorization.
Sources checked 2026-09-10 · next source check due 2026-10-10
State authorization required
These findings describe the linked sources. They do not establish that your facility qualifies for an exemption or that its application is ready. Facility type, ownership, personnel, locations and exact test systems can change the requirements.
What the official sources say
- Current COMAR 10.10.03.02 includes one or more CLIA-waived tests in the Letter of Exception route for eligible physician-office or point-of-care laboratories.
- Facility eligibility, director qualifications and state quality requirements still require review. Do not use the old excepted-test-list PDF as the current rule.
Fees and timing
Check the current agency fee notice and fee schedule. Government fees are separate from preparation-service fees. This source summary does not promise a processing or approval date.
Check my test menuWhat still needs confirmation for your facility
- 1Confirm the facility category, director and exact test menu against current COMAR before choosing a permit or Letter of Exception.
Frequently asked questions
What filing route does the cited Maryland guidance describe?
Maryland requires a state permit or Letter of Exception as well as CLIA authorization.
Which requirements are named in the cited Maryland materials?
Current COMAR 10.10.03.02 includes one or more CLIA-waived tests in the Letter of Exception route for eligible physician-office or point-of-care laboratories. Facility eligibility, director qualifications and state quality requirements still require review. Do not use the old excepted-test-list PDF as the current rule.
What do the sources establish about fees and timing in Maryland?
Check the current agency fee notice and fee schedule. Government fees are separate from preparation-service fees. This source summary does not promise a processing or approval date.
Does this page confirm CLIA approval or legal compliance in Maryland?
No. This is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device. Verify every requirement with CMS, the FDA, and your state agency before testing.
Other jurisdictions
Each jurisdiction publishes its own terminology, forms, channel, signatures, and fees.
All 52jurisdictions →Official sources behind this guide
Need help with your Maryland CLIA route?
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From test research to your Maryland application
An analyte label does not confirm a device. The exact test system and the clinic’s state route need separate review before a filing scope or price can be confirmed.