FDA 510(k), De Novo and PMA Device Pathways Corporate Training
Learn to choose and execute FDA 510(k), De Novo, and PMA pathways in live guided labs with regulatory practitioners.
Edstellar, a corporate training company, delivers corporate training that helps your team learn to select and execute the right FDA pathway for every device. Employees develop skills in device classification, substantial equivalence, de novo requests, PMA evidence, and eSTAR submissions through hands-on labs built around your product portfolio and regulatory milestones.
Instructor-led group trainingVirtual / on-site / off-site10 languagesDelivered inEnglish, Spanish, Mandarin, German, Arabic, Portuguese, Hindi, French, Japanese, Italian100+ countriesWe have delivered inUnited States, United Kingdom, India, Canada, Germany, France, Netherlands, UAE, Saudi Arabia, Singapore, Australia, Japan, Brazil, South Africa and 90+ more countries
How we build an FDA-ready submission team
The Edstellar FDA SUBMISSION Capability Model
Assess submission readiness
Skill checks baseline your team's FDA knowledge across classification, 510(k), de novo, and PMA topics.
Standardize pathway decisions
One shared playbook for classification, predicate strategy, and evidence planning that your teams reuse.
Practice in guided labs
Labs cover predicate searches, eSTAR drafting, de novo requests, clinical plans, and deficiency responses.
Measure regulatory lift
Lab reviews benchmark each employee's submission accuracy against FDA reviewer expectations.
Scale across the portfolio
One standard rolls out across product families, device classes, and submission types enterprise wide.
Need more than one program?Get a group quote
Trusted as a Leading Corporate Training Provider by
Program Overview: What is FDA 510(k), De Novo and PMA Device Pathways?
FDA 510(k), De Novo & PMA Device Pathways is a 28-hour program for regulatory affairs professionals, medtech teams, and startups navigating US device approval. It covers FDA device regulation foundations, classification and predicate strategy, the 510(k), De Novo, and PMA pathways, pre-submission strategy, eSTAR, and post-market obligations. Participants learn to choose the right pathway, not just describe them.
The program works through realistic device scenarios. Participants classify devices, build substantial equivalence arguments for 510(k)s, map De Novo strategies for novel devices, and scope the clinical evidence a PMA demands. Instructors with FDA submission experience review each strategy, flagging the pathway mistakes that cost companies a year. Peer critique mirrors the rigor of an internal regulatory review, and the program closes with a capstone where the team builds a complete end-to-end submission plan for a realistic device.
The wrong regulatory pathway is one of the most expensive mistakes in medtech: months lost, clinical work redone, investors spooked. This program teaches pathway strategy as a discipline, grounded in how FDA actually decides. Teams learn to read classification rules precisely, to use pre-submissions wisely, and to build submissions reviewers can say yes to.
The capstone submission plan covers everything: device classification rationale, pathway selection with alternatives considered, predicate or clinical strategy, testing plan, eSTAR structure, and post-market obligations, all for a realistic device profile. Reviewers challenge it the way FDA reviewers would, looking for the gaps that trigger additional information requests. Teams leave with a planning template and the strategic judgment to use it.
By the end of the program, employees can classify devices, justify pathway selection, assemble submission content, and manage review interactions with confidence. The capstone produces a full submission plan your team can adapt for real products.
What's Included in this Workshop for Your Enterprise Teams
- 1
Classification and pathway labs
Classify sample devices and justify 510(k), de novo, or PMA routes.
- 2
Submission drafting workshops
Draft eSTAR sections with evidence mapping and checklists.
- 3
De novo request exercises
Write special controls and benefit-risk summaries.
- 4
Review interaction practice
Prepare Q-sub packages and deficiency response drafts.
- 5
Capstone submission plan
Build and defend a full regulatory plan.
- Instructor-led delivery across virtual, onsite, and hybrid
- Guided labs in every module with instructor coaching
- Capstone submission plan, reviewed with your team
- Flexible scheduling around your calendar
- Lab guides and reusable submission templates included
- Group size and batches set along with you
Build your team's skills. Anywhere in the world.
Real-world use cases
from day one
Instructor-led training
for your teams
Delivered globally
in 100+ countries
Enterprise Training Solutions Customized for Your Company
One partner for instructor-led corporate training, delivered the way your teams work.
Request a Training Quote- Customized Training Delivery
- Scale Your Training: Small to Large Teams
- In-person Onsite, Live Virtual or Hybrid Training Modes
- Plan from 2000+ Industry-ready Training Programs
- Hands-On Labs on Live Infrastructure, Led by Industry Experts
FDA 510(k), De Novo and PMA Device Pathways Course Topics and Program Outline
Seven modules move from FDA foundations and classification through 510(k), de novo, and PMA practice to review strategy and a capstone submission plan. Every module pairs instruction with guided labs built around your device portfolio.
Built by Edstellar with FDA submission specialists
Built by regulatory affairs practitioners who prepare 510(k), de novo, and PMA submissions for medical devices, shaped around your device portfolio and regulatory milestones.
Skill checks baseline your team's FDA pathway knowledge across classification, submissions, and review topics.
Live instruction covers FDA foundations, classification, and pathway logic across 7 focused hours of content.
Guided labs build 510(k), de novo, and PMA drafting skills across 12 hours of supervised practice.
Your team runs review interactions and ships a capstone submission plan in 9 hours, reviewed by the instructor.
From FDA foundations to a capstone submission plan, every skill is practiced in guided labs.
Delivered as
Delivered as a hybrid program of live instruction and guided labs, scheduled around your team's calendar in flexible batches.
Explore FDA databases and device listings for a sample device list, then map each entry to its class and panel in a guided walkthrough.
learna)FDA organization and CDRH review structure
b)Device classes I, II, and III and risk logic
c)Product codes, panels, and classification regulations
d)Intended use and indications for use
e)Exemptions and enforcement discretion basics
Select predicate candidates for a mock device and draft a classification memo that records the chosen route and its rationale.
learna)Classification rules and the 510(k) decision tree
b)Predicate device selection and predicate splits
c)Substantial equivalence logic and claims
d)Product code searches in FDA databases
e)Documenting classification rationale for reviewers
Assemble a mock 510(k) evidence package with test summaries, labeling drafts, and a completed RTA acceptance checklist.
practicea)Traditional, abbreviated, and special 510(k) routes
b)Performance testing and standards conformity
c)Software and cybersecurity documentation
d)Biocompatibility, sterilization, and labeling sections
e)Refuse-to-accept screening and the acceptance checklist
Draft a de novo request summary for a novel device, including risks to health and proposed special controls for each.
practicea)De novo eligibility and direct de novo requests
b)Benefit-risk classification of novel devices
c)Drafting special controls language
d)Evidence expectations for low-to-moderate risk devices
e)Interactive review and deficiency responses
Outline a clinical evidence plan for a Class III device, mapping study endpoints to PMA safety and effectiveness claims.
practicea)PMA content structure and the manufacturing module
b)Clinical study design and IDE fundamentals
c)Panel-track and 180-day review timelines
d)Modular PMA and PMA supplements
e)Post-approval study commitments
Prepare a Q-sub meeting package with questions, device description, and testing plans, then build a post-market obligation calendar.
applya)Q-submission meetings and strategy memos
b)eSTAR structure and acceptance checklists
c)QMSR evidence mapping for submissions
d)Medical device reporting and UDI
e)Corrections, removals, and labeling compliance
Build and defend an end-to-end submission plan for a mock device in an instructor-reviewed capstone session.
applya)Pathway selection and justification memo
b)Submission section ownership and evidence map
c)Review interaction and deficiency response plan
d)Post-market compliance playbook
Customize this program tailored to your team?
Tell us your training needs: what your team already works with, the level they’re at, and the topics you want them to focus on. We’ll adjust the modules, duration and hands-on labs, and send you a customized outline for your group.
Key Skills and Outcomes Your Team Will Gain
Practical submission skills your regulatory, quality, clinical, and product employees apply to real devices and dossiers.
Classify devices and select FDA pathways
Apply classification rules, product codes, and decision logic to route each device to 510(k), de novo, or PMA.
Build predicate and substantial equivalence arguments
Search FDA databases for predicates and write clear substantial equivalence comparisons reviewers accept.
Draft de novo requests with special controls
Prepare direct de novo requests, including benefit-risk analysis and special controls for novel devices.
Plan PMA content and clinical evidence
Structure PMA submissions, map manufacturing data, and outline clinical studies that support safety and effectiveness.
Run Q-submissions and eSTAR authoring
Prepare Q-sub meeting packages, draft eSTAR sections, and use acceptance checklists to avoid refuse-to-accept issues.
Map QMS records to submission evidence
Connect QMSR design controls, verification, and validation records to the evidence each submission requires.
Manage post-market compliance obligations
Handle medical device reporting, UDI, corrections and removals, and compliant labeling after clearance or approval.
Teams that Benefit from this FDA 510(k), De Novo and PMA Device Pathways Group Training
This group training is built for medical device teams managing US market access who want reliable FDA submission skills. Content adapts to each cohort's roles, product classes, and experience, so every batch practices the workflows it owns, from classification to clearance or approval.
Route every device to the right FDA pathway
Regulatory affairs teams own submissions from concept to clearance or approval, and need reliable judgment on pathway selection, predicate strategy, and review interactions.
Workflow friction
- Predicate gaps for differentiated devices
- Evolving eSTAR acceptance expectations
- Review questions that stall timelines
How the program helps
- Faster, defensible pathway decisions
- Cleaner submissions with fewer deficiencies
- Confident Q-sub and reviewer interactions
Practice use cases
- 510(k) route planning
- De novo eligibility calls
- PMA content strategy
- Q-sub preparation
Tie QMSR records to submission evidence
Quality teams supply the design controls, verification, and validation evidence that submissions stand on, and must map records to reviewer expectations.
Workflow friction
- Scattered records across systems
- Traceability gaps at submission time
- Post-change assessment workload
How the program helps
- Submission-ready evidence traceability
- Cleaner design history files
- Fewer documentation-driven delays
Practice use cases
- QMSR evidence mapping
- Design dossier traceability
- Change control assessments
Build defensible clinical evidence packages
Clinical teams design studies and reports that support de novo benefit-risk and PMA effectiveness claims, and need to align evidence with FDA expectations.
Workflow friction
- Endpoint choices that invite questions
- Evidence gaps found late in review
- Literature vs. new data trade-offs
How the program helps
- Study designs reviewers respect
- Evidence aligned to claims
- Smarter IDE and study planning
Practice use cases
- Clinical evidence planning
- IDE study design
- Literature review strategy
Design products that clear FDA review faster
R&D teams make design and labeling decisions early that shape the submission path, and benefit from knowing what reviewers will ask.
Workflow friction
- Indications wording that invites questions
- Feature creep beyond the predicate
- Late-stage testing surprises
How the program helps
- Design choices that fit the pathway
- Earlier labeling and claims alignment
- Fewer redesigns from review findings
Practice use cases
- Design input reviews
- Indications drafting
- Verification planning
Cohorts train as a cross-functional workforce, with each small group aligned on shared regulatory vocabulary and submission standards.
Prerequisites: This program suits regulatory, quality, clinical, and product employees who work on medical devices, including newcomers to FDA submissions. Basic familiarity with medical device development helps but is not required; the program starts with FDA foundations and classification before advancing to submission drafting. We adapt examples and lab depth to each cohort's device classes and experience.
Regulatory Affairs Associate to Submission Strategist
Progress from device classification fundamentals to leading 510(k), de novo, and PMA submissions across a product portfolio.
A program that grows with device regulatory careers, from classification basics to confident submission strategy.
Mixed cohort, or several teams at once?
We can tailor the training to different teams, roles, and experience levels within the same program.
Certificate of Training Completion.
On successful completion, employees receive an Edstellar course completion certificate, recognizing their commitment to ongoing learning and professional development. It validates the skills they have built and motivates them to keep growing and contribute to organizational success.
Earned, not attended. Awarded on completion of all hands-on labs and the capstone project.
Training Delivery Modes: Virtual, Onsite and Hybrid
Choose the format that fits your team's schedule. Every mode keeps live instruction, guided labs, and instructor feedback.
Hybrid Training
Split your cohort between the training room and a live virtual connection without losing momentum. The instructor runs submission labs for both groups together, reviews each team's work, and keeps interaction live across the room and the screen.
- Live instruction across onsite and virtual sessions
- Guided labs with instructor coaching and reviews
- Submission drafting and pathway labs throughout
- Flexible scheduling without losing live interaction
Onsite Training
Bring the instructor to your site for focused, collaborative work on your devices. Teams classify products, draft submission sections, and plan review strategy together with the instructor's guidance throughout each session.
- Instructor at your facility for the full program
- Work directly on your device portfolio
- Team-based labs with immediate feedback
- Minimal travel for your employees
Live Virtual Training
Join live from anywhere with real-time instruction and guided labs. Small virtual groups draft eSTAR sections, search predicate databases, and present capstone plans, with the instructor reviewing every lab.
- Live virtual sessions with instructor guidance
- Screen-shared labs and submission walkthroughs
- Breakout groups for drafting exercises
- Works across time zones and sites
Need a training format that works for your team?
Full days, half days across weeks, or split by module. Tell us the delivery window and we schedule the cohort around it.
Frequently Asked Questions
Share your team size, timelines, and delivery preference, and we will send a detailed per-group quote with batch options.
Yes. A short discovery call aligns the program to your device portfolio, regulatory milestones, and training goals before scheduling.
Yes. Live virtual sessions include guided labs, screen-shared submission walkthroughs, and instructor reviews in small groups.
Yes. Onsite delivery brings the instructor to your facility so teams work directly on your devices and dossiers.
The program runs 28 hours of instructor-led training, typically across 4 days, with each module pairing instruction and guided labs.
Question not answered here?
Put it in the request. A training specialist answers it directly, within one business day.
Where this Training Fits in Your Team's learning path.
Choosing between 510(k), De Novo and PMA only works when your design controls and risk evidence already exist. This path puts the ISO 13485 QMS and ISO 14971 risk work first, then the FDA pathway decision, then the wider skill of filing with several regulators at once.
Why Choose Edstellar as Your FDA 510(k), De Novo and PMA Device Pathways Corporate Training Provider
Edstellar helps medical device teams master FDA 510(k), de novo, and PMA pathways through instructor-led programs built around your products. We combine practitioner trainers, guided labs, and flexible delivery to build submission skills that shorten time to clearance and approval.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
We shape labs and the capstone around your device portfolio, submission history, and the FDA pathways you actually use.
Proven Methodology
A structured assess, learn, practice, and apply journey moves your team from classification basics to submission strategy.
Practice-Based Learning
Guided labs in every module let your team draft submissions, search predicates, and plan reviews with instructor coaching.
Expert Trainers
Regulatory practitioners who prepare 510(k), de novo, and PMA submissions lead every session and review every lab.
Global Scale
We deliver consistent FDA pathway training across your sites and time zones, with cohorts scheduled around your calendar.
Measurable Outcomes
Lab reviews and the capstone submission plan show clear skill lift your managers can track after the program.
Choose FDA Device Pathways With Clear Rationale and Organized Submission Evidence
Edstellar develops FDA pathway planning through device classification, predicate strategy, substantial equivalence, De Novo, and PMA evidence. Teams build mock submission materials and pre-submission questions before preparing a complete plan. The final review examines route justification, evidence gaps, and post-market responsibilities without implying that instructor review provides FDA clearance or approval.
- Step 01
Consult
We explore regulatory and device-development responsibilities, identifying gaps in classification, predicate selection, pathway comparisons, clinical evidence planning, and pre-submission or post-market documentation.
- Step 02
Plan
We establish FDA foundations before classification and predicate strategy, then 510(k), De Novo, and PMA cases, followed by pre-submission planning and post-market obligations.
- Step 03
Align
We align US device-regulatory facilitation with regulatory, quality, clinical, and product teams, introducing submission concepts and adapting evidence exercises to device class and experience.
- Step 04
Customize
We tailor fictional devices, candidate predicates, test summaries, and clinical-evidence needs to representative products, keeping patient information and actual FDA submissions outside the course exercises.
- Step 05
Execute
Participants justify routes, assemble mock evidence, and draft Q-sub questions, receiving feedback on substantial-equivalence reasoning, proposed controls, and the link between study endpoints and claims.
- Step 06
Evaluate
We assess the submission plan for a defensible pathway, coherent evidence requirements, focused pre-submission questions, and documented actions addressing remaining testing and post-market responsibilities.
Also from Edstellar
Talent assessments
Psychometric, behavioral, leadership and 360-degree assessment.
→Training needs analysis
Needs analysis, gap identification, and a training roadmap.
→L&D consulting
Learning strategy, content, technology and ROI measurement.
→OD consulting
Org design, succession planning and cultural change.
→Managed training services
Training outsourcing, vendor management, logistics and administration.
→Coaching solutions
Executive and manager coaching that keeps skills in use.
Start an RFP shaped to your needs.
Answer three quick questions about team size, scope, and how often you need the program run, then send the request from the last step. Everything you choose travels with it, so you only fill this in once.
How many team members need training?
FDA 510(k), De Novo & PMA Device Pathways Training Packages & Pricing
Where L&D holds an annual budget, license packages price the whole year at once instead of raising a purchase order per workshop. Hours and licenses are pooled across teams, programs and locations, so unused capacity is not stranded in one department.
Starter
120
trainee licenses64 hours of group training
Tailored for SMBs
Growth
320
trainee licenses160 hours of group training
Ideal for growing SMBs
Enterprise
800
trainee licenses400 hours of group training
Designed for large corporations
Custom
Unlimited
trainee licensesDuration set by the rollout
Multi-region and multi-year
Training Packages & Pricing
Choose the training format that works for your team. Pricing is customized based on your requirements, cohort size, and delivery needs.
Request FDA 510(k), De Novo and PMA Device Pathways Training for Your Team
Share your team size, device portfolio, regulatory milestones, and timelines to receive a tailored training plan and quote. Book a discovery call to discuss your goals; we confirm availability and respond with a proposal.