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Apsis Consulting Group · FDA regulatory strategy

Know your FDA pathway before you spend on it.

A principal-led regulatory consultancy for device founders and the investors behind them. We tell you the pathway, what it will take, and how long — so you can raise with confidence.

Find your starting point → See the work
Fixed feesPrincipal-led≈ 175 days from assessment to FDA decision · see how →
HoverTap a device · predicates trace back, postdicates trace forward · illustrative
01 · Why founders and investors call usApsis Consulting Group

Regulatory is the variable that prices your company.

Every other line in the model — burn rate, runway, the size of the next round — is informed by the pathway decision. We make that decision explicit early, while it is still cheap to change, and help you communicate it to a board.

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years of combined regulatory and quality experience across the principals

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devices and products supported across IVD, SaMD, AI/ML imaging, cardiovascular, respiratory, enteral and combination products

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startups guided from first prototype toward a defensible U.S. regulatory position

Apsis Consulting GroupApsis Consulting Group, LLC · Regulatory & Quality
Regulatory Determination

Pathway and Evidence Position

ACG-RD-0000
Rev A · Composite
Product
AI software estimating disease risk from routine laboratory values, clinician-facing
Device status
Device. Non-device CDS carve-out fails criterion (iv) under FD&C Act §520(o)(1)(E) — the clinician cannot independently review the basis for a single opaque risk score.
Classification
Class II. Candidate regulation identified; its one product code has never been cited as a predicate.
Pathway
510(k)  De Novo
Predicate absence to be confirmed at Pre-Submission.
U.S. evidence
Retrospective validation against biopsy-confirmed reference. IDE exemption under 21 CFR 812.2(c) to be confirmed with FDA.
Design constraints
Diagnostic-only indication · no embedded clinical recommendation · categorical output, no individual percentages.
Principal ConsultantApsis Consulting Group, LLC
SIGNED
2026-09-10
COMPOSITE EXAMPLE FOR ILLUSTRATION · NOT A CLIENT RECORD

The deliverable is a signed position · not a slide, not an opinion

02 · Start hereApsis Consulting Group

Where are you right now?

Pick the situation closest to yours. We'll show you the central question, the pathway we would take, and what you leave with.

One situation · one route · one written position

03 · The mapApsis Consulting Group

Every device question resolves to one of five exits.

Whichever situation you picked above, it ends at one of five exits: wellness, non-device CDS, exempt Class I, a 510(k) or De Novo, or a PMA. The decision points along the way are FDA's; the evidence each exit demands is where the money goes. We get you to the right exit with the least evidence that still holds.

no · wellnessno · cdsyes · deviceiiiiii STARTYour product FDA decision · §201(h)Is it a device?Intended use · claims · software Exit · no premarket reviewGeneral Wellness Exit · §520(o)(1)(E)Non-device CDS Device · classificationRegulation & product codePredicate scan · special controls Exit · 510(k)-exemptClass I Special controlsClass II Premarket approvalClass III Exit · 90 FDA-day goal510(k) Exit · 150 FDA-day goalDe Novo Exit · 180 FDA-day goalPMA no · wellnessno · cdsyes · deviceiiiiii STARTYour productFDA decision · §201(h)Is it a device?Intended use · claims · softwareExit · no premarketGeneral WellnessExit · §520(o)(1)(E)Non-device CDSDevice · classificationRegulation & product codePredicate scan · special controlsExit · exemptClass ISpecial controlsClass IIPremarket · PMAClass III90 FDA-day goal510(k)150 FDA-day goalDe Novo180 FDA-day goalPMA
HoverTap a node

Each exit carries a different evidence burden. Pick one to see what it takes and where Apsis comes in.

FDA decision pointPathway we buildExit without premarket review
Review goals are MDUFA performance goals, not elapsed time

The pathway decides the evidence · the evidence decides the timeline · the timeline decides the raise

04 · What we doApsis Consulting Group

Three practices. One principal. Advice you can act on.

Every engagement ends in practical advice and a documented plan. Each practice is drawn here the way we work it: the predicate search, the process brought under control, the pathway chosen against your runway. Fees are fixed per engagement.

01 · Practice

Regulatory strategy & FDA interaction

From "which pathway?" to written FDA feedback. For founders who need the answer before the raise, and for teams heading into a Pre-Sub.

Executive Regulatory StrategyYou will know which pathway applies, what it costs, and how long it takes.
Pre-Submission Package + FDA InteractionFDA tells you, in writing and in person, whether your plan works — before you spend on it.
De Novo SubmissionFiled, defensible, and shepherded through the agency's questions, with interaction rounds included.
All products in this practice
Regulatory Pathway ReviewOne hour with your team, then a written review in five business days: every applicable pathway with a confidence level, the evidence each demands, and a sequenced plan to board-ready diligence.
Regulatory Strategy Working SessionHalf a day, live, with your team, when you want the pathway decision worked in the room. You leave with the decision made and a costed plan for what comes next.
Comprehensive Regulatory StrategyAdds your technical-file review, EU qualification screen, phased timeline and an investor summary. A position you can raise on and defend in diligence.
One-Issue MemoOne bounded question, signed. A written determination you can hand to a board, an investor or an auditor.
Hover a node to trace it · codes and K-numbers illustrative
02 · Practice

Quality systems

Right-sized, audit-ready, and yours. Built so the first launch carries exactly the quality system it needs — and the second product has a foundation to grow on.

QMS Foundation + Class I Software ImplementationAn audit-ready quality system, live in your eQMS, with your team trained on it.
QMS Gap AssessmentClause-level scoring against ISO 13485:2016 and FDA QMSR, with a remediation plan and a work-split.
Internal Audit & Certification SupportLead-auditor audits, corrective-action closure, and auditee-side lead through registrar Stage 1 and Stage 2.
All products in this practice
Class II ExpansionExpanded DHF, design transfer, process validation and usability engineering on the same foundation.
QMS Support RetainerA quality lead on call for change control, supplier issues, management review, registration and listing — without a hire.
Hover a point · illustrative
03 · Practice

Investor & board diligence

An independent regulatory read, time-boxed to the deal clock and written for an investment committee.

Snapshot · Core · Deep DiligenceThree depths, from the four questions every term sheet depends on to submission and manufacturing readiness with downside scenarios costed.
Buy-side & Portfolio ReviewsHidden compliance debt, integration risk and post-close RA/QA workstreams surfaced before you sign.
Fractional Regulatory AdvisoryThree tiers, from a principal on call to a fractional head of regulatory.
Five pathways against your runway · hover a lane · illustrative

Fixed fee · named scope caps · every product ends in a document

Start here

Regulatory Pathway Review. One hour with your team; a written review in five business days.

We review the technology, the timeline you are on, and every pathway that could apply — wellness, Class I, 510(k), De Novo, PMA — and put it in writing: each option with a confidence level and why, the evidence each would demand, and a sequenced plan to board-ready regulatory diligence. Built on our work across 100+ devices and products.

One hour · one document · fixed fee$3,800Credited toward any follow-on engagement within 60 days
Book the review →Investors: the same review, framed for diligence, on the deal clock
05 · How long does it take to get cleared?Apsis Consulting Group

How long does it take to get cleared?

Start to finish for an illustrative Traditional 510(k) — from the first day of our Regulatory Assessment to FDA's decision. Two factors move the number; try them.

Start to FDA decision≈ 175 daysApsis phases 85 d · FDA clocks 90 d
Factor 1 · FDA review time
90 days
MDUFA goal is 90 FDA days · could be faster, often slower
Factor 2 · Pre-Submission
Add a Pre-Sub: + 90 days up front · FDA confirms the pathway before you build the submission
Apsis phase · duration fixed in the proposalFDA clock
Illustrative · a Pre-Sub costs ≈ 90 days up front and typically saves an Additional Information cycle later
How our engagement differs

Fixed durations. Pre-Sub first. The eSTAR written while FDA's answers are fresh.

The usual wayApsis
Hourly meter, invoiced through FDA's silenceOne fixed number per phase, agreed before work starts
Scope described in adjectivesNamed caps — features, predicates, revision rounds
Senior partner sells, junior bench deliversThe principal you scope with does the work and signs it
Pre-Sub filed, then wait and seeEvery likely FDA response modeled before filing; the eSTAR built while the answers are fresh
"Payment on delivery" — pending your sign-offPayment on transmission — an act we perform, dated by us

Fixed durations on our side · one slider for FDA · one decision for you

06 · Selected workApsis Consulting Group

What the case studies actually show.

Client identities are withheld under confidentiality obligations. Every figure below is drawn from engagement records. Open any file for the full account.

IVD SaMD · CE-marked → U.S.510(k) → De Novo
No predicate — converted into a defined De Novo path inside one review cycle.
No predicate 510(k)proposed predicate declined by fda new pathwayDe Novo also confirmed by fdaU.S. study IDE-exempt21 CFR 812.2(c)

CE-marked IVD. We developed a strategy, performed a gap assessment and the FDA Pre-Submission — and turned FDA's "no suitable predicate" into a defined route with the evidence plan rebuilt around it.

Read the file
Problem

Software device presented disease risk from blood biomarkers. The company needed to know whether EU evidence would carry in the U.S. and what a U.S. validation would have to look like.

What we did

Screened every product code, ran the non-device CDS four-criterion test, built the substantial-equivalence argument with a reference device, and filed with a U.S. clinical plan built on an extensive retrospective database.

Outcome

FDA found no suitable predicate — and the engagement converted that into a defined De Novo pathway inside one review cycle. Indications, output and validation plan were rebuilt accordingly. De Novo Pre-Sub and execution followed.

Quality system · kit manufacturerISO 13485 · 21 CFR 820
5,368 units, zero defects — and an audit verdict moved from "no" to "yes."
Zero defects audit 1"no" 5 carsclosed in 5 wks sop set · quality agreementregistrar stage 1 · stage 2 audit 2 · +9 mo"meets" 5,368 / 0units / defects

Twenty FDA device listings across three entities, a national-lab customer's corrective action request, and a deficient quality system that would not pass inspection. Nine months later: it did.

Read the file
Problem

A specimen-collection kit manufacturer had received a supplier corrective action request from its laboratory customer and needed to reach ISO 13485:2016 certification.

What we did

262-row clause-level gap analysis; rebuilt the quality manual and full SOP set; authored the inter-entity quality agreement; two full-standard internal audits as lead auditor; five corrective actions to closure; auditee-side lead through registrar Stage 1 and Stage 2 audits.

Outcome

Internal audit verdict moved from "non-compliant" to "meets" in nine months. All five first-audit CAPAs closed within five weeks. 100% specification compliance across 5,368 units. Certification program carried forward.

Cardiovascular · novel sensingStrategy → Pre-Submission
Every FDA objection anticipated in writing before the meeting.
Anticipated proposedaccepted at meeting 30 subjects 85 3 fda responses modeled per question · 66-criterion rubric · resolved in one cycle

A continuous blood-pressure monitor using a novel sensing modality. We modeled three FDA responses to every question; the sponsor arrived with resolutions and closed the clinical validation in one cycle.

Read the file
Problem

The sponsor needed FDA agreement on predicate suitability for a novel technology and clarity for their upcoming clinical validation.

What we did

Screened 31 product codes and roughly 1,000 devices; applied FDA's four-factor predicate test; authored the full Pre-Submission including the validation protocol and SAP; scored it against a 66-criterion rubric with pre-drafted actions for each likely response.

Outcome

FDA concurred on non-clinical testing without discussion and provided clear, minor adjustments to the clinical validation plan and the requested concessions.

Enteral access · no clean predicateStrategy → Pre-Submission
69 days to a five-person CDRH panel — and a bounded clinical ask.
69 days before pre-subafter fda feedback open-ended clinical study · unfundable∞ 60–90 day evaluation · 2–3 tube replacements five-person cdrh panel incl. division director · day 69

A new feeding-tube mechanism with no obvious predicate. FDA converted an open-ended clinical demand into a clear 60–90 day evaluation: the difference between a fundable program and an indefinite one.

Read the file
Problem

A novel feeding system had no obvious predicate, and a variant carried weight-management positioning that would import a clinical burden of a different order.

What we did

Screened all 17 weight-loss product codes against pivotal-study precedent; proposed classification; assembled a 27-document predicate library and SE table; authored the Pre-Submission to get clear concordance from FDA.

Outcome

A five-person CDRH panel including the division director gave positive feedback within 69 days. FDA recommended a predicate and bounded the clinical validation to a 60–90 day evaluation with extrapolation to longer-term use.

AI CADx · global manufacturerStrategy → Pre-Submission → 510(k)
Breakthrough pays on PMA. Not on 510(k).
Pays on PMA 510(k)de novopma ≈ ½ month gained < 3 months > 6 months median time-to-decision, designated vs. not · plus incremental cost and cms/cpt implications

Is Breakthrough Device Designation worth pursuing for an AI diagnostic? Answered with arithmetic: median time gained by pathway, incremental designation cost, and the reimbursement implications — a finding that redirects spending rather than endorsing a program.

Read the file
Problem

A manufacturer wanted a defensible cost-benefit answer on pursuing designation — a question usually answered by enthusiasm.

What we did

Comparative time-to-decision analysis of designated vs. non-designated devices by submission type; cost model for the incremental designation burden; reimbursement analysis across the CMS transitional coverage pathway and CPT Category I vs. III implications.

Outcome

Median time gained: roughly half a month for 510(k), under three months for De Novo, over six months for PMA. Designation earns its cost on the PMA path and generally does not on 510(k).

Digital neurology · ML softwareStrategy → Class I launch
One product-code decision separated exempt from a full 510(k).
Exempt code a · 510(k)-exempt · limited claims dozens of registered devices code b · 510(k) required · diagnostic claims three cleared devices with matching intended use lock the algorithmadaptive voids exemption

Speech-based cognitive assessment software. We isolated the classification basis and the constraint that makes the exempt path hold: a static, pre-trained model.

Read the file
Problem

ML analysis of verbal-fluency tasks for early cognitive decline needed the quickest defensible U.S. entry.

What we did

Classified the device and chose a product code that is 510(k)-exempt, allowing a quicker launch with limited claims. Identified adaptive algorithms that would void the exemption; assessed overseas clinical data against FDA's OUS-data guidance.

Outcome

Recommended the exempt path with the claim constraints and algorithm-locking requirement that make it hold.

Six files · every figure from engagement records · client identities withheld

07 · InsightsApsis Consulting Group

Short, technical, cited.

Two analyses, each built around a figure we drew from the primary source — and a live view of the AI/ML device landscape we track every week.

Analysis · Generative AI · September 2026

FDA just published the map to a fully autonomous AI doctor. It didn't draw the route.

All fourteen of FDA's worked examples counted into the agency's own activity × consequence grid — and the four moves that get a product from one cleared function to full autonomy.

Read the analysis →
Analysis · AI chat · September 2026

An AI health chat is wellness, CDS or a device depending on what the user asks — and what the model says back.

A query × response matrix that turns an open-ended language risk into a bounded classification problem, with the design constraints that keep a chat on the right side of each line.

Read the analysis →
The landscape we track

We keep up with the latest in AI/ML devices.

Every week we review what FDA has authorized against the AI-Enabled Medical Devices list — by year, by panel, by pathway — so a client's predicate scan starts from this week's landscape, not last year's.

Authorizations per year
HoverTap a year
Share by FDA review panel · cumulative
HoverTap a panel
Sources · FDA, AI-Enabled Medical Devices list · Three Decades of FDA Authorizations of AI/ML-Enabled Medical Devices (1995–2025), Cureus 2026 — era totals, 2025 count and panel shares as published; 2016–2024 yearly values reconciled to era totals · 42 devices before 2016 not plotted · *2026 is partial: 73 authorizations with decision dates through 30 March 2026, the most recent FDA list update (list total 1,524; our era-reconciled cumulative 1,503 — the 21-device gap is method, not missing devices)Other panels · hematology, gastroenterology-urology, ophthalmic, clinical chemistry, anesthesiology

Get the weekly listWhat FDA authorized this week, what changed, and what it means for your predicate scan.
One email a week · unsubscribe any time · no client information, ever

Primary sources cited · fact, interpretation and recommendation kept separate

08 · AboutApsis Consulting Group

A boutique by design.

Apsis Consulting Group was founded in 2022 to give early- and growth-stage device companies the kind of regulatory judgment that comes with a seasoned executive — without the hire.

We stay deliberately small. The principal scopes the work, does the work, and signs the determination. Where an engagement needs depth we do not carry in-house — clinical biostatistics, human factors, cybersecurity testing, EU notified-body strategy — we bring in vetted specialists under our direction, and you always know who is doing what.

Roughly four in five of our clients are companies entering the U.S. with a product already marketed elsewhere, or software companies deciding whether they are a device at all. Those are the two questions we have answered most often, and the two we are fastest at.

Speaking engagements
Diagnostics and Digital Connectivity
EMWA · 2025
FDA Strategy for Korean MedTech Innovators
DEC 2025
Regulatory Due Diligence 101 — U.S. FDA MedTech
INVESTOR WEBINAR · JAN 2026
Ery Anguiano, Founder and Principal ConsultantPrincipalHoverTap to re-encode
Founder & Principal Consultant

Ery Anguiano

Chemical engineer and biotechnologist with 16+ years in medical device regulatory affairs and quality — inside global manufacturers, embedded in startups, and as a senior regulatory consultant to device companies across IVD, SaMD, AI/ML imaging, cardiovascular, respiratory and combination products.

  • Authored FDA Pre-Submissions across cardiac, AI/ML software, respiratory, IV access, enteral access, urology, neurological and IVDs, each returned with written agency feedback
  • Lead auditor for ISO 13485:2016 internal audits; auditee-side lead through registrar Stage 1 and Stage 2
  • Non-device determinations, General Wellness boundary analyses and CDS configuration work for consumer-facing AI health products

Principal-led · specialists under direction · you always know who is doing what

09 · Book a callApsis Consulting Group

Thirty minutes. One clear next step.

What happens next

We reply within one business day with two or three times. The call is a working session: you describe the product and the decision you are facing; we tell you what we would do first and whether we are the right fit.

If we are not the right fit, we will say so and, where we can, point you to who is.

475-237-7994

54 State Street, STE 804 #8573
Albany, New York 12207