Advanced Course - Registration of
Medical Devices with FDA
The FDA market is worth US$180 billion per year. Professionals with expertise in 510(k), PMA and QMSR are capturing this market - those without it are being left behind. 48 hours that change your regulatory career.
Advanced Level · 48 hours
This course is for you if you are…
Master medical device registration
in the US market
Comprehensive advanced training for professionals who need to navigate the FDA regulatory system - from the beginning to an approved submission.
specialist
progressive
De Novo · QMSR
Fundamentals of the FDA Regulatory System
FDA and CDRH structure, FD&C Act, Safe Medical Devices Act. Regulatory history and FDA × ANVISA × EU comparison.
Key regulations (21 CFR 807, 812, 814, 820, 830), Establishment Registration, Device Listing and UDI. A solid foundation for navigating the US regulatory ecosystem.
Classification and Regulatory Strategy
Classes I, II and III, Product Codes, Regulation Numbers and Panels. Classification criteria and their implications for the chosen registration pathway.
Mapping the 5 entry pathways: 510(k), PMA, De Novo, HDE and IDE. A regulatory decision tree and product positioning strategy.
510(k) Submission: From Preparation to Clearance
Substantial equivalence, predicate device and 510(k) types: Traditional, Abbreviated and Special. Submission structure and content.
510(k) Summary, performance tests, biocompatibility and software (21 CFR 820.30). Responding to FDA Additional Information Requests and deficiencies.
PMA, De Novo, Alternative Pathways and Clinical Evidence
PMA: criteria, modules and review. IDE: investigational device exemption and conducting US clinical studies under 21 CFR Part 812.
De Novo: workflow, novelty criteria and resulting Special Controls. HDE for orphan devices. Clinical evidence and statistical strategies for complex submissions.
QMS, Design Controls and FDA Technical Requirements
QMSR (21 CFR 820 revised in February 2026): incorporation of ISO 13485:2016 into the FDA standard. Structure of the required quality system.
Design Controls (21 CFR 820.30): DHF, DMR, DHR. Validation processes, CAPA, nonconformity control and software as a medical device (SaMD) requirements.
Post-Market, Audits, Market Access and International Strategy
MDR (Medical Device Reporting - 21 CFR 803), Field Safety Corrective Actions, Recalls and FDA post-market surveillance.
FDA inspections (EIR, 483), distribution, importation and US market access. International strategy: ANVISA-FDA regulatory links, distribution and pricing in the US market.
Your Foundation ANVISA is Your Greatest Asset with FDA
Professionals with ANVISA, RDC 665/2022 or ISO 13485 knowledge have a strategic advantage: FDA's new QMSR incorporates ISO 13485:2016. The course translates that foundation into US market-specific requirements.
Frequently Asked Questions
Your questions about the Advanced FDA Medical Device Registration Course answered.
Do I need previous FDA experience to take the course?
This is an advanced course requiring basic regulatory knowledge (ANVISA, ISO 13485 or equivalent). RA, Quality and Engineering professionals and consultants already working with medical devices are ready for the content. Specific previous FDA experience is not required.
What is QMSR and why is it important for the course?
QMSR (Quality Management System Regulation) replaced the former 21 CFR Part 820 in February 2026 and incorporates ISO 13485:2016 as FDA's mandatory quality standard. It is a turning point: companies already certified to ISO 13485 have an advantage during the transition. Module 5 is dedicated entirely to this topic.
What is the difference between 510(k), PMA and De Novo?
These are the main FDA clearance/approval pathways. 510(k) is for Class II devices with a predicate device; PMA is for high-risk Class III devices (requiring robust clinical evidence); and De Novo is for new devices without a predicate but with moderate risk. The course covers all 5 pathways in depth in Modules 2, 3 and 4.
Do you offer in-house courses for teams?
Yes! The Advanced FDA Registration Course can be tailored for corporate teams, ideal for companies with 6 or more professionals. We adapt the content, case studies and practical exercises to your company's products and processes. Contact us to request a proposal.
How long does an FDA 510(k) registration process take?
On average, FDA takes 3 to 6 months to review a 510(k) after formal submission acceptance. However, the full process - including submission preparation, testing, technical documentation and possible responses to Additional Information Requests - may take 12 to 18 months, depending on the product and QMS maturity. The course covers strategies to accelerate this process.
The Window of Opportunity Is Open - For a Short Time
QMSR entered into force on 2 February 2026. Professionals and companies that act early have a real competitive advantage over those still discovering what has changed.
