Postgraduate Diploma in FDA 510(k)/De Novo: Dossier Preparation
800-hour online Postgraduate Diploma in FDA 510(k)/De Novo: Dossier Preparation. 8 modules covering 21 CFR Part 807, Subpart E (premarket notification 510(k)), 21 CFR Part 860 (classification and De Novo requests) and FDA eSTAR. Assigned tutor and open enrolment.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Describe the FDA regulatory system for medical devices.
Determine the appropriate regulatory pathway for a device.
Demonstrate substantial equivalence to a predicate device.
Prepare a De Novo request for novel devices.
Compile the technical content of the dossier in eSTAR format.
Plan interaction with the FDA through Q-Submissions.
Meet post-market obligations after authorisation.
Who it's for
- FDA regulatory affairs specialist who wants to specialise in FDA 510(k)/De Novo: Dossier Preparation.
- Regulatory technical writer who wants to specialise in FDA 510(k)/De Novo: Dossier Preparation.
- US market access consultant who wants to specialise in FDA 510(k)/De Novo: Dossier Preparation.
- Quality manager for medical devices who wants to specialise in FDA 510(k)/De Novo: Dossier Preparation.
- Regulatory project manager who wants to specialise in FDA 510(k)/De Novo: Dossier Preparation.
- Post-market specialist who wants to specialise in FDA 510(k)/De Novo: Dossier Preparation.
- Engineering or science graduates seeking to enter medical device manufacturers.
What you'll work with
- 21 CFR Part 807, Subpart E (premarket notification 510(k))
- 21 CFR Part 860 (classification and De Novo requests)
- FDA guidance The 510(k) Program: Evaluating Substantial Equivalence (2014)
- 21 CFR Part 820 (QMSR)
- 21 CFR Part 812 (investigational device exemption, IDE)
- ISO 10993-1 (biological evaluation)
- IEC 60601-1
8 modules · 800 h
1.1FDA structure and the CDRH1.2FD&C Act and device amendments1.3Device classification: Classes I, II and III1.4Marketing pathways: 510(k), De Novo and PMA1.5Classification panels and 21 CFR 862–8921.6General and special controls1.7Establishment registration and listing1.8Differences from the European framework1.9FDA regulation of software and SaMD1.10Case study: determining the regulatory pathway
2.1Substantial equivalence2.2Selecting the predicate device2.3Equivalence decision diagram2.4Traditional, special and abbreviated 510(k)2.5Safety and Performance Based Pathway2.6510(k) exemption2.7MDUFA review timelines2.8Decision letters and outcomes2.9Changes to devices already authorised2.10Practice: searching for and comparing predicates
3.1Eligibility criteria for De Novo3.2Low- and moderate-risk devices with no predicate3.3Proposed special controls3.4Benefit-risk analysis3.5Contents of the De Novo request3.6Timelines and review process3.7Creating a new classification3.8De Novo following an NSE3.9De Novo success stories3.10Workshop: proposing special controls
4.1eSTAR format4.2Device description4.3Labelling and instructions for use4.4Biocompatibility under ISO 109934.5Sterilisation and shelf life4.6Electrical safety and electromagnetic compatibility4.7Software documentation4.8Cybersecurity in submissions4.9Bench performance testing4.10Laboratory: structure of an eSTAR
5.1When clinical data are required5.2IDE studies and significant risk5.3Clinical data from outside the United States5.4Real-world evidence5.5Human factors engineering5.6Standards recognised by the FDA5.7Statistics in device studies5.8Analytical performance data5.9Presenting clinical results5.10Practice: justifying the need for clinical data
6.1Q-Submission programme6.2Pre-Submission: preparation and meetings6.3Requests for additional information6.4Responding to deficiency letters6.5Interactive review6.6Refuse to Accept (RTA) review6.7Timelines and communication strategies6.8Breakthrough Devices Program6.9Consultants and US agents6.10Case study: responding to an additional information request
7.1Quality Management System Regulation (QMSR) and ISO 134857.2Adverse event reporting: MDR7.3Recalls and corrections7.4UDI and the GUDID database7.5FDA inspections7.6Warning letters7.7Changes requiring a new 510(k)7.8Post-market surveillance7.9Predetermined change control plans7.10Workshop: assessing a design change
8.1Device description8.2Regulatory strategy8.3Predicate analysis8.4Test plan8.5Clinical and human factors strategy8.6Preparing the Pre-Submission8.7Dossier structure8.8Schedule and budget8.9Report and presentation8.10Final review with the tutor
How you'll learn
Fully 100% online training on the SEIUM Institute campus, with downloadable materials, recorded classes and an assigned technical tutor. There are no fixed timetables: students progress at their own pace within the enrolment period, which makes it possible to combine the programme with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is FDA eSTAR, CDRH Portal, Veeva Vault RIM, Adobe Acrobat Pro, in free, academic or evaluation versions. Case studies are based on real procedures: substantial equivalence comparisons with predicate devices, preparation of Pre-Sub (Q-Submission) requests, and review of performance test reports. Assessment is continuous across modules, plus a final integrative project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Describe the FDA regulatory system for medical devices.
Determine the appropriate regulatory pathway for a device.
Demonstrate substantial equivalence to a predicate device.
Prepare a De Novo request for novel devices.
Compile the technical content of the dossier in eSTAR format.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. A university degree is not required.
- Internet connection and a computer capable of running the programme's software.
- A sufficient level of Spanish to follow technical regulatory texts.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme comprises 800 hours in total, spread over 6 to 8 months. That is an average of 10 to 15 hours per week, which is compatible with a full-time job.
You will work with FDA eSTAR, CDRH Portal, Veeva Vault RIM and Adobe Acrobat Pro. Free, academic or evaluation versions are used, and the tutor will indicate the free alternative where one exists.
A SEIUM Institute diploma upon passing the continuous assessment and the final integrative project. This is in-house training, not an official qualification from the Ministry.
Yes. Modules passed in a course or postgraduate diploma in the same area can be credited towards the advanced programme. Check the recognition policy when enrolling.
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