Rigorous science deserves a regulatory strategy built to the same standard.

Built for founders and scientists shipping life-changing LDT and IVD products.

FDA Update: February 2, 2026 -- Click to expand ▼

The Quality Management System Regulation (QMSR) became effective on February 2, 2026, amending the device current good manufacturing practice (CGMP) requirements of 21 CFR Part 820. The QMSR incorporates by reference ISO 13485:2016 -- Medical devices: Quality management systems -- Requirements for regulatory purposes, harmonizing FDA's CGMP framework with international standards used by other regulatory authorities worldwide.

After February 2, 2026, FDA inspections follow the updated Inspection of Medical Device Manufacturers Compliance Program (7382.850). The prior inspection frameworks (7382.845 and 7383.001) are no longer in use. All quality management system documentation in this kit is current with QMSR requirements.

Source: FDA.gov -- Quality Management System Regulation (QMSR)

32 templates, worksheets, and guides for IVD teams navigating FDA regulatory strategy. Built by a process development engineer with hands-on MCED liquid biopsy and CLSI validation experience.

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THE PROBLEM

You are navigating regulated assay development for a novel device with no cleared predicate and no internal regulatory playbook

Novel IVD programs fail at the regulatory layer, not the science layer. A first-in-class assay with no cleared predicate, a team without deep FDA regulatory experience, and a 12-month runway is one bad study design decision away from a 12-month delay. Every mistake at the design controls stage compounds: wrong design inputs require re-executed studies, undocumented feasibility work cannot support a submission, stability studies started late cannot be accelerated. The window to get this right is the first 90 days.

Your acceptance criteria do not exist yet -- and the standard depends entirely on which regulatory world you are in

CLIA allows you to review your data and make a professional judgment call on performance. FDA does not. Under design controls, acceptance criteria must be documented in the approved study protocol before a single data point is collected -- the moment you set the threshold after seeing the results, the study is invalid for FDA purposes regardless of how good the science is. This is the sharpest edge of the LDT-to-PMA transition: the analytical work may be identical, but the documentation discipline is categorically different.

Your stability studies have not started -- and the clock is already running

Every month you delay starting real-time stability studies is a month added to your submission timeline. A four-year plasma stability claim requires 49 months of data -- but FDA accepts submission with two to three completed timepoints, with ongoing updates as additional timepoints complete. The clock only runs if the study has started.

Your design inputs are written for CLIA, not PMA

A CLIA validation plan specifies categories of evidence -- precision, accuracy, analytical sensitivity. An FDA design input specifies verifiable, traceable specifications with pre-defined acceptance criteria tied to an approved protocol. If you write design inputs to CLIA standards and later pursue a PMA, you will likely need to re-execute a significant portion of your analytical validation -- not because the science was wrong, but because the documentation was not written to a standard FDA can trace. If there is any realistic probability of a PMA in your future, write to FDA standards from day one.

WHAT'S INCLUDED

32 deliverables across 6 modules

MODULE 01

Regulatory Pathway Selector

4 deliverables

Routes you to the right FDA pathway in 5 questions, then hands you the predicate table and Pre-Sub template to act on it.

Tool Excel DOCX
MODULE 02

QMS Foundation

5 deliverables

ISO 13485 checklist, QMSR crosswalk, and the SOP build list that tells you which procedures to write first and which ones can wait.

Excel DOCX
MODULE 03

Design Controls

7 deliverables

Traceability matrix, risk register, V&V explainer, DHF structure guide, and ML classifier governance for teams building software-driven assays.

Excel DOCX
KEY MODULE MODULE 04

Analytical Validation

9 deliverables

CLSI EP05, EP06, EP07, EP09, EP17, and EP25 worksheets with formula-driven analysis. The EP17 LOD probit worksheet handles qualitative binary outputs correctly.

Excel DOCX
MODULE 05

Labeling Documentation

4 deliverables

Intended use drafting template with worked examples, IFU per 809.10, labeling compliance checklist, and package insert template.

Excel DOCX
MODULE 06

Expert Field Guide

3 deliverables

Lessons from building a first-in-class MCED test through PMA preparation. What most teams wish they had known before their first Pre-Sub meeting.

DOCX

See where your assay lands

The pathway selector tool asks 5 questions about your device and routes you to one of 7 FDA regulatory outcomes with timeline, cost, and next-step guidance.

Full tool and complete kit unlocked with purchase. Get the kit

Built by someone who has done this.

I built this kit because the information I needed when I started did not exist in one place. I spent several years on a multi-cancer early detection liquid biopsy program at a major diagnostics company, working across the full arc of IVD development: from early assay development and design control initiation through analytical validation and PMA submission. That program ran as both a Laboratory Developed Test under CAP/CLIA and as a PMA-track IVD under FDA design controls simultaneously -- which means I have lived on both sides of that transition and I know exactly where the gap is.

On the analytical validation side, I designed and executed CLSI EP-series studies for a novel cfDNA methylation assay with no cleared predicate, no established reference method, and a multi-cancer intended use that required characterizing performance across dozens of cancer types. We built contrived sample strategies from scratch, wrote study protocols that had to survive FDA review, and learned the hard way which acceptance criteria need to be pre-specified before data collection begins and which study designs generate FDA deficiency letters regardless of how good the science is.

On the regulatory strategy side, I worked through Pre-Submission meeting feedback from the FDA and the LDT-to-PMA transition that most teams underestimate. I have seen what happens when design inputs are written for CLIA launch and then a PMA becomes the goal. I have seen stability studies start six months late. I have seen fast pivots create documentation gaps that took months to close. The kit reflects what I would have wanted in hand before those mistakes were made.

This is not a literature review. It is not a regulatory consultant's boilerplate. It is the toolkit I built from real experience, for teams at the stage where the right decisions are still possible and the wrong ones are still recoverable.

Content reflects the author's professional experience and judgment. It does not represent the views of any employer, past or present. No proprietary or confidential information is disclosed.

Product Feedback

"The EP17 LOD worksheet saved us from designing our probit study incorrectly. Every other template we found assumes a quantitative measurand. This one handles qualitative binary outputs."

Head of Analytical Development and Biostatistics /
Series A liquid biopsy startup

"We used the 510(k) deficiency cheat sheet as a pre-submission checklist and caught two issues that could have generated deficiency letters. That alone was worth the price of the kit."

Principal Scientist /
Pre-seed molecular diagnostics

"Module 06 is the content I wish existed when we started. The section on contrived sample development as a standalone program changed how we resourced our validation timeline."

Co-founder and CSO /
Seed-stage MCED startup

Two ways to start

One purchase. Lifetime access. Unrestricted reuse.

STARTER KIT

$199 one-time

  • -- Modules 01 and 05 (8 deliverables)
  • -- Pathway selector tool
  • -- Pre-Sub meeting request template
  • -- Intended use and IFU templates
  • -- 21 CFR Part 809 labeling checklist
Get the starter kit
RECOMMENDED
FULL BUNDLE

$499 one-time

  • -- All 32 deliverables across 6 modules
  • -- 7 CLSI analytical validation worksheets
  • -- ML classifier and SaMD governance guide
  • -- 510(k) deficiency cheat sheet
  • -- MCED expert field guide (Module 06)
  • -- FDA reviewer red flags table (15 entries)
  • -- Lifetime access to updates
Get the full kit

Common questions

No. This kit is educational content based on direct practitioner experience. It does not substitute for guidance from a qualified regulatory affairs professional, legal counsel, or FDA. The standard disclaimer applies to all deliverables. Use this kit to orient your regulatory strategy, then engage a regulatory professional to validate your specific approach.

DOCX templates and guides (editable in Word or Google Docs), Excel worksheets with formula-driven analysis (compatible with Excel and Google Sheets), and a self-contained HTML pathway selector tool that runs in any browser. Everything downloads as a single ZIP file.

The kit is designed for molecular diagnostics and liquid biopsy programs, with specific depth in cfDNA-based assays and multi-cancer early detection tests. The CLSI study worksheets, design control templates, and labeling documents apply broadly to any IVD. The Module 06 field guide and the pre-populated examples in Modules 03 and 04 are specifically calibrated for liquid biopsy and MCED programs.

All content reflects the regulatory landscape as of April 2026. QMSR (effective February 2, 2026) is incorporated throughout Modules 02 and 03. The FDA LDT Final Rule (May 2024) is addressed in Module 01. The Nancy Gardner Sewell Medicare MCED Screening Coverage Act (signed February 3, 2026) is referenced in Module 06. CLSI standards referenced are the current editions as of April 2026.

This kit gives you the structure and the starting knowledge. For program-specific regulatory strategy, engage a regulatory affairs consultant with PMA experience in your device class. The Pre-Sub meeting template in Module 01 is designed to help you get the most value from FDA engagement. If you need a recommendation for a consultant, contact ivd.readiness.support@gmail.com.

Regulatory references

Primary sources underpinning all kit content. All regulatory documents are current as of April 2026.

FDA regulations and guidance
21 CFR Part 820 -- Quality Management System Regulation (QMSR) Effective February 2, 2026. Incorporates ISO 13485:2016 by reference. Governs QMS requirements for all finished device manufacturers.
21 CFR Part 809 -- In Vitro Diagnostic Products for Human Use Labeling requirements for IVD devices including intended use, package insert, and instructions for use.
FDA Guidance: De Novo Classification Process Guidance for requesting De Novo classification for novel, low-to-moderate risk devices without a predicate.
FDA Guidance: In Vitro Companion Diagnostic Devices August 2014. Requirements for co-development and co-submission of companion diagnostics with therapeutic products.
FDA Guidance: Benefit-Risk Determinations in PMA and De Novo Classifications Framework for benefit-risk assessment in PMA and De Novo submissions.
FDA Final Rule: Quality System Regulation Amendments (QMSR) January 2024 final rule amending 21 CFR Part 820 to incorporate ISO 13485:2016. Effective February 2, 2026.
FDA Final Rule: Laboratory Developed Tests (LDT Rule) May 2024. Phases out enforcement discretion for LDTs. High-risk molecular diagnostic LDTs subject to premarket review requirements.
FDA Guidance: The Q-Submission Program Governs Pre-Submission (Q-Sub) meetings. Strongly recommended before designing pivotal validation studies.
ISO standards
ISO 13485:2016 -- Medical devices: Quality management systems Incorporated by reference into 21 CFR Part 820 (QMSR). The foundational QMS standard for medical device manufacturers globally.
ISO 14971:2019 -- Medical devices: Application of risk management International standard for risk management throughout the device lifecycle. Required under ISO 13485 and referenced in QMSR.
ISO 9000:2015 -- Quality management systems: Fundamentals and vocabulary Clause 3 incorporated by reference into QMSR alongside ISO 13485:2016. Provides foundational QMS terminology.
CLSI analytical performance standards
CLSI EP05-A3 -- Evaluation of Precision of Quantitative Measurement Procedures Third edition. Study design and statistical analysis for within-run repeatability and within-laboratory reproducibility.
CLSI EP06-Ed2 -- Evaluation of Linearity of Quantitative Measurement Procedures Second edition. Serial dilution study design and polynomial regression analysis for reportable range determination.
CLSI EP07-A2 -- Interference Testing in Clinical Chemistry Second edition. Endogenous and exogenous interferent panel design and acceptance criteria.
CLSI EP09-A3 -- Measurement Procedure Comparison and Bias Estimation Third edition. Deming regression and Bland-Altman analysis for method comparison studies.
CLSI EP17-A2 -- Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures Second edition. LoB, LoD, and LoQ determination using parametric and non-parametric methods.
CLSI EP25-A -- Evaluation of Stability of In Vitro Diagnostic Reagents Real-time, accelerated, and freeze-thaw stability study design and shelf-life claim support.
Legislation and coverage policy
Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act Signed February 3, 2026. Establishes Medicare coverage pathway for MCED tests upon FDA approval. Directly affects commercial strategy for any MCED liquid biopsy program.
Federal Food, Drug, and Cosmetic Act -- Section 520(f) Statutory authority for FDA's device CGMP requirements including the Quality Management System Regulation.