FDA Regulation and Access to the US Market — Mastering the QMSR (21 CFR Part 820)
The United States is the world's leading market for medical devices. Selling on US soil requires mastering a demanding regulatory framework: FDA classification, registration pathways (510(k), PMA, de novo), a quality system compliant with the QMSR (Quality Management System Regulation, 21 CFR Part 820 revised, in force since February 2, 2026) and documented interactions with the FDA. This virtual classroom day gives RA teams and export management a complete and operational reading of the US regulatory framework, from classification strategy to dossier submission.
Audience Regulatory affairs managers and officers, export directors, product development project managers involved in a US market access project.
Learning objectives
- ▸ Describe the organization of the FDA, the structure of 21 CFR and the logic behind classifying medical devices into three risk classes
- ▸ Distinguish the applicable registration pathways (510(k), PMA, de novo, 513(g)) and select the relevant pathway for a given device
- ▸ Explain the requirements of the QMSR (21 CFR Part 820 revised) and identify the residual gaps with ISO 13485:2016 in the mandatory records (DHF, DMR, DHR, QSR)
- ▸ Build the content plan of a 510(k) or PMA dossier, incorporating clinical evaluation requirements and realistic submission timelines
- ▸ Anticipate an FDA interaction: pre-submission (Q-sub), response cycles, risks of 483 and Warning Letter
- ▸ Develop a US market access roadmap adapted to the class and nature of one's device
Expected outcomes
- ✓ Participants leave with a regulatory reading grid directly applicable to their export project, the ability to interact with a US Agent or an FDA consultant, and the elements needed to define a QMSR compliance action plan.
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
Prior exposure to medical device regulation (MDR 2017/745 or ISO 13485) is recommended. No formal prerequisite required.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·This training is not Qualiopi-certified and is not eligible for OPCO funding
- ·Funding through own funds or the company's training budget
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
The FDA and the US regulatory environment (1 h)
- ·Presentation of the FDA and its centers responsible for medical devices (CDRH, CBER)
- ·Structure of 21 CFR: regulatory texts, guidance documents and their legal value
- ·Principles of the Federal Food, Drug, and Cosmetic Act applicable to medical devices
- 02
FDA classification and choice of registration pathway (1 h)
- ·Three-class risk classification system
- ·Controls required according to the class
- ·Overview of registration pathways: Premarket Notification (510(k)), Premarket Approval (PMA), de novo, 513(g)
- ·Criteria for selecting the pathway suited to one's device
- ·Practical positioning case studies
- 03
The QMSR: 21 CFR Part 820 revised, in force since February 2, 2026 (1 h 30)
- ·From QSR to QMSR: reason for the reform and alignment with ISO 13485:2016
- ·Scope of the QMSR and responsibilities of the manufacturer
- ·Key requirements: design controls, production controls, purchasing management, CAPA, complaint handling, Medical Device Reporting (21 CFR Part 803)
- ·FDA-specific records: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR)
- ·Residual gaps QMSR vs ISO 13485 and compliance actions
- 04
Building your submission dossier: 510(k) and PMA (1 h 30)
- ·The 510(k) process: philosophy, choice of predicates, demonstration of substantial equivalence, role of clinical evaluation
- ·Structure and content of the 510(k) dossier
- ·The pre-submission (Q-sub): usefulness, organization, timelines
- ·The PMA process: products concerned, role of the IDE (Investigational Device Exemption), dossier structure
- ·Estimated submission timelines and frequent bottlenecks
- 05
Interactions with the FDA and post-market surveillance (1 h)
- ·Official modes of communication with the FDA
- ·Site registration and product listing
- ·Understanding a 483 and a Warning Letter: origins, consequences, response strategy
- ·Product recall and correction systems (21 CFR Part 806, Part 810)
- 06
Synthesis workshop: US export roadmap (30 min)
- ·Construction of an individual roadmap per participant: identification of the registration pathway, QMSR divergence points to address, submission milestones
- ·Discussion and Q&A with the trainer
Assessment of learning
Assessment methods
End-of-day QCM covering the key regulatory points (classification, registration pathways, QMSR requirements, dossier structure). Results are communicated individually at the end of the session.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full participation in the session. This certificate does not constitute a certification recognized by the RNCP or the RS. It attests to participation in a continuing professional training action compliant with the provisions of Article L.6313-1 of the French Labor Code.
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Materials provided
- ·Complete course materials in PDF (updated to incorporate the QMSR in force since February 2, 2026)
- ·Comparative table QSR vs QMSR vs ISO 13485:2016
- ·FDA export roadmap template (editable file)
- ·Annotated regulatory references: links to official FDA texts (eCFR, CDRH guidance documents)
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
890 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·This training is not Qualiopi-certified and is not eligible for OPCO funding
- ·Funding through own funds or the company's training budget
Personalised quote within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.