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For at-home wellness diagnostics companies
Wellness Regulatory Assessment
Calling a product wellness does not settle its FDA status.
Know how FDA’s current policy may apply before you market the product or commit to a regulatory path.
- $6,900 fixed fee
- Written assessment
- Two to four weeks
- Led by Dan Simpson, RAC
- $6,900 fixed fee
- Written assessment
- Two to four weeks
- Led by Dan Simpson, RAC
Request a call with our team
Tell us about your product and what you need to determine. We’ll follow up to schedule a 30-minute call.
The question
Does FDA’s general wellness policy apply to your product?
Understand how FDA’s current general wellness policy may apply to your product, the likely regulatory path, and whether FDA contact is warranted.
Some products marketed for wellness fall outside the policy. FDA also recognizes that certain noninvasive, low-risk products may present validated values, ranges, trends, baselines, or summaries when the intended use remains solely wellness.
The answer requires a review of the specific product.
The assessment
What the assessment covers
Dan Simpson, Director of Regulatory Affairs at DCN Dx, leads the review of your product information. In two to four weeks, you receive a written assessment covering:
- 01Whether the product appears to fall within FDA’s current general wellness policy
- 02If it appears to fall outside the policy, the likely device status, classification, and marketing pathway when the available information supports those conclusions
- 03Whether FDA contact is warranted and the most appropriate route, which may include informal FDA or CDRH communication, a Pre-Submission, a 513(g) Request for Information, or another approach
The process
How it works
- 01
Request a call.
Tell us about the product and what you need help determining. Our team will follow up to schedule a 30-minute call and confirm whether the Wellness Regulatory Assessment is the right fit for your product.
- 02
Confirm the scope.
DCN Dx confirms the product, materials, questions, deliverable, and timing in a short fixed-fee proposal.
- 03
Review the product.
Dan leads DCN Dx’s regulatory review of the intended use, claims, collection or sensing method, results, and relevant labeling, marketing, and software materials.
- 04
Receive your written assessment.
You receive the product-specific analysis and recommended next steps in two to four weeks.
About the team
Dan Simpson, RAC
Director of Regulatory Affairs, DCN Dx
Dan Simpson is Director of Regulatory Affairs at DCN Dx and a RAC-credentialed, ASQ-certified medical device auditor with more than 15 years in IVD and medical device regulatory and quality roles. Before DCN Dx he led regulatory affairs at ERI Group and spent 14 years running quality and regulatory affairs at Corgenix Medical Corporation. He works with IVD manufacturers on FDA 510(k), De Novo, and PMA submissions as well as IVDR conformity assessment, across point-of-care, OTC, companion diagnostics, and high-complexity assays. Dan leads the assessment.
- Credentials
- RAC-credentialed, ASQ-certified medical device auditor
- Experience
- More than 15 years in IVD and medical device regulatory and quality roles
- Submissions
- FDA 510(k), De Novo, and PMA submissions; 513(g) requests
Why DCN Dx
- 01
Former IVD sponsors
DCN Dx’s clinical research and regulatory team is made up of former IVD sponsors. They have sat in the sponsor’s seat, so they see problems coming that a generalist would not.
- 02
Product-specific review
The analysis considers the product’s intended use, risk, claims, collection or sensing method, results, and software functions.
- 03
Written assessment
The assessment states how FDA’s policy may apply, the facts supporting that view, and the recommended next step.
- 04
Additional support when needed
DCN Dx can separately scope regulatory, clinical, assay development, manufacturing, reader, or software work identified during the review.
Frequently Asked Questions
A written assessment of how FDA’s current general wellness policy may apply to the product, the likely route-to-market implications, and the most appropriate next step for FDA communication, if any.
Dan Simpson, RAC, Director of Regulatory Affairs, leads the assessment. DCN Dx’s clinical research and regulatory team is made up of former IVD sponsors who have carried their own diagnostics through FDA and EU IVDR review.
No. The assessment recommends whether and how to contact FDA. Preparing or supporting an informal inquiry, Pre-Submission, 513(g) request, or other FDA interaction is separate work.
No. The assessment is DCN Dx’s professional opinion based on the information reviewed. It is not an FDA determination, classification decision, clearance, approval, or final Agency action.
The assessment explains the likely regulatory implications and the next decisions to make. A full regulatory strategy, FDA interaction, submission, or clinical program can be scoped separately.
The written assessment is delivered in two to four weeks from kickoff and receipt of the materials needed for review.
No. A 513(g) request is one way to obtain FDA’s views on classification and applicable requirements, but it is not a classification decision, clearance, approval, or final Agency action. The assessment helps determine whether a 513(g), a Pre-Submission, informal communication, or no immediate FDA contact is the most useful next step.
If the assessment leads to a qualifying larger engagement with DCN Dx, the $6,900 fee will be credited toward that work. The proposal will define eligibility and timing.
Next step
Request a call with our team
Tell us about the product and what you need help determining.
Request a call with our team
Services for wellness diagnostics companies
When the assessment identifies additional work, DCN Dx can support regulatory strategy, product development, manufacturing, and clinical evidence.
CDMO
Assay development
Lateral flow assay development, transfer, scale-up, and manufacturing in Carlsbad.Learn more CDMOThe miniDxR reader
Customizable readers for quantitative and semi-quantitative lateral flow tests, with options for data transfer and branded industrial design.Learn more CROClinical trials
Study design, biostatistics, and trial execution from a CRO dedicated to diagnostics, including CLIA waiver and point-of-care studies.Learn more CRORegulatory affairs
510(k), De Novo, and PMA submissions, pre-submission strategy, and IVDR support.Learn moreWellness Related Resources
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