State filing guide
CLIA waiver application and requirements in Massachusetts.
Ask about my application — no payment todayMassachusetts retains CMS-116 plus its on-site test list by email; exclusively waived laboratories remain exempt from state clinical-laboratory licensing.
Sources checked 2026-10-31 · next source check due 2026-11-30
Additional application documents
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.
Get the Massachusetts CLIA waiver checklist by email
The federal CMS-116 steps, what Massachusetts's official sources say, what to confirm for your facility, and the official links, in one email you can keep. Free.
What the official sources say
- DPH requires CMS-116 plus the Laboratory Tests Performed On-Site List, emailed to CLIALab@mass.gov. Its current linked supplement is printed LIST OF LABORATORY TEST PERFORMED ON-SITE, revised October 2015; use the original two-page form and counting instructions without modification.
- The October 24, 2022 notice remains linked by the current DPH laws index: exclusively waived laboratories need no state clinical-laboratory license, but must receive the federal Certificate of Waiver before testing and retain CLIA, infectious-disease reporting and M.G.L. c. 111D § 8 duties. No separate clinical-laboratory-license application is added for this exempt route; the on-site supplement is still required.
- Clinical Laboratory Program, Division of Health Care Facility Licensure and Certification, Massachusetts Department of Public Health: 67 Forest Street, Marlborough, MA 01752; phone (617) 660-5385; fax (617) 753-8240 in the September 2026 CMS directory. The published fax/address do not establish initial-filing acceptance by those channels.
- The live CMS-116 download is (03/24), OMB 0938-0581, PRA expiration 03/31/2027. CMS listing metadata is inconsistent, and a separate November 2026 guide illustrates (04/2026); retain the current linked form and obtain Eric/DPH edition confirmation rather than replacing it. Rechecked 2026-11-09: the direct CMS download now serves Form CMS-116 (04/2026), OMB 0938-0581, expiration 04/30/2029, matching the November 2026 guide; the edition discrepancy observed on October 31 is resolved.
- DPH still says to send fees to the coupon address; current federal paperless instructions instead require Pay.gov after the emailed coupon. No fixed Massachusetts initial-processing or certificate-issuance interval was found in the reviewed sources.
Fees and timing
Federal Certificate of Waiver: $248 for two years, effective January 27, 2024. Client pays CMS through Pay.gov after the electronic fee notification; no payment with CMS-116. The waived-only exemption removes the state clinical-laboratory-license application and its fee; no separate CLIA application surcharge was identified in reviewed DPH sources, not a blanket exemption from other facility obligations. No approval date promised; government fees remain separate from preparation-service fees.
Check my test menuWhat still needs confirmation for your facility
- 1Confirm the currently accepted CMS-116 edition with Eric/DPH because CMS publishes inconsistent form-edition metadata; retain both existing packet forms pending confirmation.
- 2Confirm initial unassigned CLIA/facility-number handling on the current on-site list and reconcile its instrument/kit, complexity and annual-volume fields using the official counting rules.
- 3Before transmission, the authorized human confirms signed-file acceptance at CLIALab@mass.gov and exact menu-specific reporting duties; do not infer fax/mail filing or a processing guarantee.
Frequently asked questions
What filing route does the cited Massachusetts guidance describe?
Massachusetts retains CMS-116 plus its on-site test list by email; exclusively waived laboratories remain exempt from state clinical-laboratory licensing.
Which requirements are named in the cited Massachusetts materials?
DPH requires CMS-116 plus the Laboratory Tests Performed On-Site List, emailed to CLIALab@mass.gov. Its current linked supplement is printed LIST OF LABORATORY TEST PERFORMED ON-SITE, revised October 2015; use the original two-page form and counting instructions without modification. The October 24, 2022 notice remains linked by the current DPH laws index: exclusively waived laboratories need no state clinical-laboratory license, but must receive the federal Certificate of Waiver before testing and retain CLIA, infectious-disease reporting and M.G.L. c. 111D § 8 duties. No separate clinical-laboratory-license application is added for this exempt route; the on-site supplement is still required. Clinical Laboratory Program, Division of Health Care Facility Licensure and Certification, Massachusetts Department of Public Health: 67 Forest Street, Marlborough, MA 01752; phone (617) 660-5385; fax (617) 753-8240 in the September 2026 CMS directory. The published fax/address do not establish initial-filing acceptance by those channels. The live CMS-116 download is (03/24), OMB 0938-0581, PRA expiration 03/31/2027. CMS listing metadata is inconsistent, and a separate November 2026 guide illustrates (04/2026); retain the current linked form and obtain Eric/DPH edition confirmation rather than replacing it. Rechecked 2026-11-09: the direct CMS download now serves Form CMS-116 (04/2026), OMB 0938-0581, expiration 04/30/2029, matching the November 2026 guide; the edition discrepancy observed on October 31 is resolved. DPH still says to send fees to the coupon address; current federal paperless instructions instead require Pay.gov after the emailed coupon. No fixed Massachusetts initial-processing or certificate-issuance interval was found in the reviewed sources.
What do the sources establish about fees and timing in Massachusetts?
Federal Certificate of Waiver: $248 for two years, effective January 27, 2024. Client pays CMS through Pay.gov after the electronic fee notification; no payment with CMS-116. The waived-only exemption removes the state clinical-laboratory-license application and its fee; no separate CLIA application surcharge was identified in reviewed DPH sources, not a blanket exemption from other facility obligations. No approval date promised; government fees remain separate from preparation-service fees.
Does this page confirm CLIA approval or legal compliance in Massachusetts?
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
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