Clinical Laboratory Federal & State Regulations
FDA Approved Waived & PPM Test Lists
- Waived Test List CLIA - Clinical Laboratory Improvement Amendments - Currently Waived Analytes (fda.gov)
- PPM Test List Provider-performed Microscopy Procedures (cms.gov)
- FDA Approved OTC COVID-19 Antigen Test List https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests?utm_medium=email&utm_source=govdelivery
- Waived Tests CPT Code List CLIA Waived Tests and CPT Codes
CLIA Regulations
Clinical Laboratory Federal laws & regulations About CLIA | CDC
CLIA State Agency Phone & Email Contacts
The CDC maintains a list of state agency contracts that is accessible to anyone who wishes to apply for a clinical laboratory testing certificate or to find out additional information about testing. The list is located at STATE SURVEY AGENCIES (CLIA CONTACT LIST) (cms.gov)
State Specific Regulations & State Agency Websites
- Alabama does not have any state specific regulations although they do have specific licensure application requirements at Facilities | Alabama Department of Public Health (ADPH) (alabamapublichealth.gov) and CLIA | Alabama Department of Public Health (ADPH) (alabamapublichealth.gov)
- Alaska does not have any state specific regulations. Their website for licensure application can be reached at https://health.alaska.gov/dph/Labs/Pages/clia/default.aspx
- American Samoa does not have any state specific regulations or its own CLIA office. To file for a CLIA license for American Samoa, contact the San Francisco CMS office directly at CLIA_SanFrancisco_Office@cms.hhs.gov or 415-744-3696
- Arizona does not have any state specific regulations. Their website for licensure application can be reached at ADHS - Laboratory Licensure & Certification - Clinical Laboratory Certification - Home (azdhs.gov)
- Arkansas does not have any state specific regulations that I could locate or a website.
- California has a website for their Laboratory Field Services which manages the CLIA licensure application process and monitors federal & California state regulations, located at Clinical Laboratory Improvement Amendments (CLIA) The state specific regulations can be located at Regulatory Information - Laboratory Field Services (ca.gov)
- Nevada regulations NAC: CHAPTER 652 - MEDICAL LABORATORIES (state.nv.us) licensure information Medical Laboratory Licensing (nv.gov) and application ALiS - Online Licensing System (aithent.com)