Get your required CLIA application prepared for review, signature, and manual submission.
For most clinics, the official CMS-116 is required; some states also require—or use—their own application. WaivedLab prepares the forms from the facts you provide. You verify every field and sign before any authorized manual transmission.
From $395No payment todayInitial scope response target: 1 business day
Your filing package
Organized from intake to follow-up
One clear process, with you in control of every decision and signature.
We prepare
Official forms, test menu, and state checklist
You verify
Review every detail, then sign
Manual submission
A human sends through the confirmed agency channel
We track
Agency follow-up and fee reminders
Software never signs or autonomously submits. Agency approval and timing are never guaranteed.
Document preparation
We organize the filing and required steps.
You remain responsible
You choose, verify, review, and sign.
The agency decides
We cannot promise approval or timing.
Preliminary route builder
Check your route before requesting a quote.
Choose your workflow, state, tests, and exact devices. This screening does not determine eligibility or approval; it tells us whether the case is ready for a filing quote, manual confirmation, or independent expert review.
Your facts
Build the preliminary checklist
Educational screening only—not an eligibility, waived-status, compliance, or approval determination.
State route
No state assumed
Choose the clinic's actual testing location before we show state information.
Your next route
Complete the inputs, then build your checklist.
We will show exactly one outcome: filing quote, manual confirmation, expert review, or collection-only guidance.
Do not begin testing, purchase equipment, advertise a test, or treat a green flag as final waived status based on this website. Official agency records and the exact manufacturer instructions control.
How it works
A clear path from questions to a trackable filing
You do not need to become a CLIA paperwork expert. You do need to stay in control of the facts, decisions, and signatures.
- 01
Check your route
Tell us where your clinic operates, whether you test on site, and which tests you plan to offer.
- 02
Confirm scope and price
We confirm the filing pathway, what is included, and your flat service fee before work begins.
- 03
Review and sign
We prepare the forms and supporting packet. Your laboratory owner or director checks every detail and signs.
- 04
Confirm manual submission and track
The written scope confirms the required agency channel and sender. Any WaivedLab transmission is manual and requires separate written authorization.
Transparent pricing
Know which dollars go where
Your total cost has separate parts. We confirm the WaivedLab service fee before work starts; government and expert fees are not hidden inside it.
1 · WaivedLab service
$395
Federal application only
$795
Federal application plus a required state form—or a state-specific application
Flat document-preparation and manual filing-support fee. No payment on this page; scope and price are confirmed first. Routes with unresolved requirements receive manual scope confirmation before any price is shown.
2 · Government fees
$248
CMS-listed federal certificate fee, where applicable
Paid directly to CMS—not to WaivedLab. State fees vary, and some states use their own laboratory pathways instead of or in addition to the federal route.
Check the official CMS fee scheduleConfirm the amount on your CMS notice. Government fees are not WaivedLab revenue and are not included in our flat fee.
3 · Expert help, if needed
Separately scoped and priced
If your case needs professional laboratory, legal, medical, or compliance judgment, we pause and tell you. Any qualified professional is engaged separately.
No expert fee is assumed, bundled, or charged without a separate agreement.
Your confirmed total = WaivedLab service fee + applicable government fees + separately approved expert help, if any.
Check my routeWhat you receive
A complete, reviewable filing package
Not a generic PDF guide. Your deliverables are organized around the information and route you confirm.
Preview a fictional, redacted sample packetPrepared application
The official CMS-116 and any required state form—or the applicable state-specific application—prepared from your approved intake.
Test and device worksheet
Your planned test menu organized for exact device verification before filing.
State requirements checklist
Required state forms or applications, the manual filing channel, agency contacts, and applicable fee steps.
Review-and-sign packet
A clean package for your owner or director to verify and sign—WaivedLab never signs for you.
Submission record
When transmission is included and authorized, confirmation of what was sent, when, and to which agency.
Administrative follow-up
Agency correspondence tracking, fee reminders, and certificate-status follow-up.
Routine administrative work
What WaivedLab handles
- Collecting and organizing your filing information
- Preparing forms and state-specific checklists
- Assembling your review-and-sign packet
- Manual submission instructions and, when included, authorized transmission
- Tracking administrative agency follow-up
Professional judgment
When we stop and flag it
- Choosing your tests, devices, or clinical workflow
- Interpreting test complexity or manufacturer instructions
- Laboratory-director or personnel qualification questions
- Legal, medical, billing, or compliance advice
- A non-routine state or agency issue
We tell you what needs qualified input before the filing proceeds. WaivedLab does not claim that a particular consultant reviews every case or that an expert relationship already exists.
Choose the right kind of help
DIY, WaivedLab, or a consultant?
WaivedLab sits between doing everything yourself and hiring a specialist for professional judgment.
DIY filing
Best when you know the process
You research the route, prepare every form, manage signatures, submit, and track the agencies yourself.
- No preparation-service fee
- Your time and error risk stay with you
WaivedLab
Best for routine filing support
We prepare and organize the administrative work. You verify, decide, and sign; the sender and manual agency channel are confirmed in writing. Any WaivedLab transmission requires separate written authorization.
- Flat fee confirmed before work
- Organized packet and follow-up
Qualified consultant
Best when judgment is required
A qualified professional advises on test systems, personnel, laboratory direction, complex workflows, or other specialized questions.
- Professional analysis for your facts
- Scope and fee are separate
FAQ
Questions clinics ask before filing
The short version: confirm your exact workflow, state, tests, and devices before treating any route as final.
Ask another questionDo I need a CLIA certificate if my clinic only collects specimens?+
Possibly not. If your clinic only collects specimens and an outside laboratory performs and reports every test, the collection site may not need its own CLIA certificate. If any device at your location produces a patient result, the analysis is different. Confirm the exact workflow before filing.
What does the WaivedLab fee include?+
It covers document preparation, your state-specific requirements checklist, a review-and-sign packet, manual submission instructions and, when included in the written scope, authorized transmission and administrative follow-up. Government fees, testing devices, and separately engaged professional advice are not included.
Are government fees included in the flat fee?+
No. Government fees are paid directly to CMS or the applicable state agency. For the standard federal route, CMS currently bills the certificate fee separately. State fees vary, and some states operate their own laboratory programs.
Who reviews and signs the application?+
Your laboratory owner or director reviews the completed packet, confirms that the information is accurate, and signs it. WaivedLab never signs on your behalf. The written scope confirms who sends the signed packet through the required manual channel; any WaivedLab transmission requires separate written authorization.
When would I need a laboratory consultant?+
You may need qualified professional input when a question involves test complexity, device selection, personnel qualifications, laboratory direction, clinical workflow, or another judgment beyond document preparation. If that happens, we pause and explain the issue before any separate engagement.
How long does the process take?+
WaivedLab aims to provide an initial scope response within one business day. For standard cases, our preparation target is to deliver the application packet for your review and signature within five business days after you accept the written scope and we have all required information and documents. Client response time is separate. Agency processing is separate and never guaranteed. Complex or incomplete cases receive a route-specific timeline before payment.
Does software or AI submit the application automatically?+
No. Software may organize your intake and populate draft fields on the official form, but it does not sign, make professional judgments, or autonomously submit an application. You verify every field and sign. The completed packet is then sent manually through the confirmed agency channel by the sender identified in the written scope.
Does selecting a test mean that every device for it is CLIA-waived?+
No. Waived status can depend on the exact manufacturer, model, intended use, specimen type, and instructions. The exact test system must be verified before filing or purchasing equipment.
Can I begin testing while the application is pending?+
Do not begin testing based only on a submitted application or this website. Confirm that all required federal and state permissions are active before testing, advertising tests, or billing for them.
Clear responsibilities
We prepare the filing. You control the laboratory decisions.
WaivedLab
- Prepares and organizes documents
- Builds your review-and-sign packet
- Confirms the manual channel and authorized sender
- Transmits only when included and separately authorized
- Tracks administrative follow-up
Your clinic
- Chooses tests, devices, and workflow
- Provides complete and accurate information
- Reviews and signs every form
- Pays applicable government fees
CMS or the state agency
- Determines the applicable requirements
- Reviews the filing
- Controls processing time
- Issues, denies, or requests changes
Important: WaivedLab is a document-preparation service and educational resource, not a law firm, medical provider, laboratory director, or compliance adviser. We do not choose your test menu or clinical model. Approval and timing are not guaranteed. Do not begin testing, advertise a test, bill for testing, or buy equipment based only on this website. Verify your exact test system and active permissions with CMS, FDA, your state agency, manufacturer instructions, and qualified professionals as appropriate.
Start with clarity
Find out which route and flat fee fit your clinic.
Complete the two-minute check. No payment today; our initial scope-response target is one business day.