1. Acceptance and order of documents
By using the website, you agree to these Terms for that use. Submitting the checker or inquiry does not require you to buy the service and does not authorize a filing. A service engagement begins only when you accept a written WaivedLab quote or scope and satisfy any stated payment condition.
If an accepted written quote conflicts with these Terms, the quote controls only for its specific scope, price, schedule, and stated cancellation terms. These Terms control everything else unless both parties agree otherwise in writing.
2. Service scope
WaivedLab provides administrative document preparation and human-controlled submission support for CLIA Certificate of Waiver and applicable state pathways. The accepted quote identifies the location, filing route, and deliverables included.
Depending on that scope, work may include preparing application fields from your intake, organizing test-system details, assembling a state checklist, identifying signature points, identifying the required manual submission channel and sender, transmitting an authorized filing when expressly included, and tracking agency follow-up. Work not listed in the accepted scope is not included.
There is no universal state add-on. If a jurisdiction has a state-specific filing requirement, WaivedLab manually confirms the current program or form, filing channel, signatures, known government fees, and case scope before issuing a final written quote. A website page or checker result does not by itself establish that scope or price.
3. Your information and decisions
You are responsible for complete and accurate clinic, ownership, location, personnel, test-menu, device, and workflow information. You must promptly disclose changes that could affect the packet.
You—not WaivedLab—select the services your clinic offers and the tests and devices it uses. You are responsible for confirming device-specific waived status, instructions for use, personnel obligations, and current requirements with qualified advisers and the applicable official sources.
4. Quotes, payment, and added work
The initial checker and inquiry are free. No payment-card information is collected on this website. Before paid work begins, WaivedLab will send a written quote that states the service fee, included work, payment instructions, and any known exclusions.
WaivedLab will not charge for added work without your approval. A change in clinic facts, filing route, test menu, device, state requirement, or requested turnaround may require a revised quote when it materially changes the accepted scope. Ordinary clarification and correction work for the initial application is governed by Section 10 and is not added work. Unless the quote says otherwise, prices are in U.S. dollars and payment is due before document preparation begins.
Later operational changes—including a new director, address, testing location, owner, test menu, device, phone number, or laboratory email—are separate update or refiling services. WaivedLab confirms the current jurisdiction-specific process and obtains your approval of a new written quote before beginning them.
5. Cancellation and refunds
You may cancel by emailing hello@waivedlab.com. There is no cancellation charge before you accept a quote. After acceptance, any cancellation and refund terms stated in that quote control.
If an accepted quote does not state different terms, WaivedLab will refund service fees paid for work not yet performed. Work already performed—including research, a prepared draft, a completed packet, or an authorized submission—is not refundable and will be reasonably allocated if only part of the scope is complete. A fully prepared packet or submitted filing may be considered completed work for refund allocation. That classification does not turn an included initial-application correction under Section 10 into separately chargeable work.
This section does not limit the correction process in Section 10 or any non-waivable right provided by applicable law.
6. Government and third-party fees
Federal, state, local, mailing, testing-device, legal, and independent-expert costs are separate from the WaivedLab service fee unless the accepted quote expressly says otherwise. You ordinarily pay agency fees directly to the agency.
Agency and third-party fees may be nonrefundable under their own rules. WaivedLab does not control those rules and cannot issue a refund of money it did not receive.
7. Review, signature, and authorization
You must review the completed packet for accuracy and sign all required forms. WaivedLab does not sign for an owner, director, applicant, or other responsible person.
The accepted scope identifies whether WaivedLab or another authorized sender must send the signed packet through the required email, mail, portal, or other manual agency channel. Software does not sign or autonomously submit an application.
A website inquiry, accepted quote, payment, or signed form does not by itself authorize WaivedLab to transmit a filing. If WaivedLab is the confirmed sender, we transmit only after you approve the completed packet and provide separate written authorization identifying the filing. You may withdraw authorization in writing before transmission. It cannot be withdrawn after the filing has already been transmitted.
When WaivedLab transmits an authorized filing, we record what was sent, when, through which channel, and to which agency, and provide the available transmission evidence. A sent-email record, portal confirmation, mailing tracking, or similar evidence shows transmission; it is not an agency acknowledgment or approval. Some agencies do not issue a separate receipt.
8. Expert escalation
WaivedLab does not provide legal, medical, billing, laboratory-director, test-selection, or professional compliance advice. If the work raises a question requiring professional judgment, WaivedLab may pause the affected work and ask you to obtain independent advice before preparation or submission continues.
You choose and retain any independent professional under a separate scope and fee. Unless a written agreement expressly says otherwise, that professional is not WaivedLab's employee, agent, subcontractor, or representative, and WaivedLab is not responsible for the professional's advice.
A professional review is not promised merely because WaivedLab accepts a case. If a professional reviewer is included or arranged for a particular filing, the written scope identifies that reviewer's role, the applicable fee or inclusion, and any authorized information sharing before work begins. WaivedLab does not promise a named reviewer unless that commitment appears in the accepted scope.
An assigned qualified reviewer may contact you directly for case-specific clarification only if you expressly authorize that contact. Direct-contact consent is optional and separate from permission to disclose case information, separate from any professional engagement, and separate from submission authorization. You may withhold it or revoke it in writing at any time for future contact.
9. No agency guarantee
CMS, state agencies, and other authorities—not WaivedLab—decide eligibility, completeness, fees, processing time, inspection requirements, and approval. WaivedLab does not guarantee that a test system is waived, that a clinic qualifies, that an agency will accept or approve a filing, or that it will act by a particular date. You must not begin testing based only on a WaivedLab draft, submission confirmation, estimate, or website page.
10. Corrections
Tell us as soon as you find a possible error or receive an agency request. Reasonable clarifications, corrected fields, supporting items, and related resubmission work needed to complete the initial application within the accepted filing route are included without an added WaivedLab service fee. This includes an ordinary agency correction request and any transcription, formatting, or assembly error made by WaivedLab.
You must review and sign any revised form that requires your signature. If WaivedLab is the confirmed sender, a materially revised packet must also be covered by written submission authorization before WaivedLab transmits it.
A changed or newly disclosed fact that materially changes the filing route, a new test system or location, a change of director or owner, a later operational change, a new filing program, or work outside the accepted initial scope may require a new quote. WaivedLab will explain the distinction and obtain written approval before charging for added work. Government fee consequences will be explained in writing, but agency refund decisions remain outside WaivedLab's control.
11. Service timing
WaivedLab's initial scope-response target is one business day. For an accepted standard case, the preparation target is a review-ready application packet within five business days after the written scope is accepted, payment is received, all required information and documents are complete, the filing route is confirmed, and the assigned WaivedLab administrative reviewer has accepted the case.
Client review, correction, signature, and authorization time is separate. A state-specific, complex, or incomplete case receives a case-specific schedule before payment. Agency processing, acknowledgment, and approval time is outside WaivedLab's control and is never part of the five-business-day preparation target.
12. Website information
Website guides and checker results are general educational and routing information, not a case determination or professional advice. Requirements change. Official CMS, FDA, state-agency, manufacturer, and other authoritative materials control over a conflicting website summary.
13. Privacy and communications
Our Privacy Notice explains how inquiry and service information is handled. You agree that WaivedLab may contact you at the details you provide about your inquiry, quote, packet, authorization, submission, and related support. Do not send protected health information through the checker or initial inquiry.
14. Questions and notices
Send questions, cancellation requests, authorization changes, and correction notices to hello@waivedlab.com. WaivedLab is operated by Covo Franco Digital LLC, a Wyoming limited liability company, with its registered address at 30 N Gould St Ste N, Sheridan, WY 82801. Notices and requests may be sent to hello@waivedlab.com.
Need to compare these Terms with a quote? Email us before accepting it. We will clarify the scope, fee, and authorization checkpoint in writing.