FDA MedTech Regulatory Update 2026
- Get up to speed on current FDA expectations
- Plan your 2027 U.S. activities
- Stay ahead on emerging topics like AI/ML and cybersecurity
- Officially certified according to ISO 9001 and ISO 21001
Online-Seminar
From
1.290,00 âŹ
plus VAT
Services & Process
Veranstaltung - 1.290,-⏠zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space, technical support, and an optional pre-meeting.
Booking details
Online-Seminar
From
1.290,00 âŹ
plus VAT
Services & Process
Veranstaltung - 1.290,-⏠zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space, technical support, and an optional pre-meeting.
Get a compact update on key FDA requirements for medical devices in 2026 and practical guidance for your U.S. planning in 2027. The seminar covers regulatory pathways, FDA interaction, QMSR, clinical data, postmarket surveillance, AI / ML, PCCP and cybersecurity, always with a practical MDR-to-FDA perspective for European manufacturers.
Your speakers
Christoph Kiesselbach
Schrack & Partner
Reutlingen,
Germany
Consultant and Partner;
Mr Kiesselbach has been a consultant at Schrack & Partner for quality management, technical documentation and approval of medical devices…
Your speaker
Christoph Kiesselbach
Schrack & Partner
Reutlingen,
Germany
Consultant and Partner;
Mr Kiesselbach has been a consultant at Schrack & Partner for quality management, technical documentation and approval of medical devices since 2013. Since 2016, his responsibilities have expanded as a partner and freelance management consultant.
Diego Sanoja GarcĂa
Asphalion S.L.; Madrid, SPAIN
Manager, MedTech (Medical Devices)
Diego Sanoja GarcĂa is a Biomedical Engineer specialising in regulatory affairs and quality for the MedTech sector. He completed his…
Your speaker
Diego Sanoja GarcĂa
Asphalion S.L.; Madrid, SPAIN
Manager, MedTech (Medical Devices)
Diego Sanoja GarcĂa is a Biomedical Engineer specialising in regulatory affairs and quality for the MedTech sector. He completed his undergraduate studies in Bioengineering and Biomedical Engineering, followed by a Master's degree in Digital Health and a Postgraduate Degree in Implementing Regulatory Requirements for Medical Devices. At Asphalion, he is responsible for leading the regulatory and quality strategy for medical device manufacturers across the EU, UK and US markets, guiding products through CE and UKCA certification and FDA submissions. His areas of expertise include Medical Device Software and AI-enabled devices, in vitro diagnostics, combination products, and clinical and performance evaluation under MDR and IVDR. He is a certified ISO 13485 Lead Auditor and a member of the Artificial Intelligence and New Technologies Working Group of the Spanish Association of Biocompanies (AseBio).
What to Expect
- FDA requirements for medical devices and key differences from MDR
- Regulatory pathways, submissions and FDA interaction
- QMSR, clinical evidence and inspection readiness
- Postmarket surveillance, recalls and safety signals
- AI / ML, PCCP and cybersecurity for device software
Who Should Attend
This seminar is intended for professionals from the medical device industry who are involved in regulatory, quality, clinical or market access activities with a U.S. focus.
It is particularly relevant for those working in:
- Regulatory Affairs
- Quality Management
- Clinical Affairs
- Postmarket Surveillance
- Market Access
- Project Management for U.S. submissions
Participants should already have a basic understanding of medical device regulation, ideally in the context of the European MDR. Initial involvement in U.S. projects or planned FDA submissions is helpful but not required.
Objective of the Event
This seminar gives you a concise and practice-oriented update on current FDA requirements for medical devices and on regulatory developments that are relevant for planning U.S. activities in 2027.
It covers key submission pathways, FDA interaction, first practical experience with QMSR, clinical and postmarket requirements and current topics such as Breakthrough Devices, TAP, AI / ML, PCCP and cybersecurity. The seminar also provides practical orientation on planning issues including user fees, submission timelines, registration and listing, and the coordination of important U.S. roles and responsibilities.
Your Benefit
- Understand the FDA system from a European MDR perspective
- Identify the right regulatory pathway and avoid common submission pitfalls
- Assess current expectations regarding QMSR, clinical evidence and FDA interaction
- Strengthen your planning for postmarket surveillance, user fees and operational responsibilities
- Gain practical orientation on AI / ML, PCCP and cybersecurity requirements for device software
Programme
09:00 - 17:00 CET
09:00
- Participants' expectations and current U.S. projects
09:15
Christoph Kiesselbach
- Roles: manufacturer, U.S. Agent, importer
- Device classification and regulatory pathway
- 510(k), De Novo and PMA pathways
- eSTAR and common pitfalls
- Leveraging your MDR setup
10:15
Christoph Kiesselbach
- Q-Sub as a planning tool for EU manufacturers
- Avoiding Refuse to Accept decisions
- Strategic FDA interaction
11:00
11:15
Christoph Kiesselbach
- What QMSR / ISO 13485 has changed
- Typical weak points: design controls, documentation, CAPA
- Inspection process, expectations and typical weak points
12:00
13:00
Diego Sanoja GarcĂa
- Good Clinical Practice for devices: 21 CFR Part 812 (IDE), Part 50 (informed consent), Part 56 (IRB) and Part 54 (financial disclosure); alignment with ISO 14155 and ICH E6(R3); data integrity and ALCOA+ expectations
- Investigational Device Exemption (IDE): significant-risk versus non-significant-risk determination, the IDE application and approval route for SR studies, abbreviated requirements for NSR studies, and IRB oversight
- When U.S. clinical data is expected: evidence needs across PMA versus 510(k) and De Novo, agreeing endpoints and study design early through the Q-Sub / Pre-Submission program, and U.S. site and IRB considerations
- Using EU (MDR) and other OUS data for FDA: acceptance criteria under 21 CFR 812.28 (GCP conformance, applicability to the U.S. population and medical practice, and FDA ability to inspect), leveraging ISO 14155 investigations, and gap analysis between MDR clinical evidence (CER and PMCF) and FDA expectations
13:50
Diego Sanoja GarcĂa
- Mandatory reporting under 21 CFR Part 803 (deaths, serious injuries and malfunctions) and how these events populate the MAUDE database
- Using MAUDE for risk management input, postmarket surveillance and competitive intelligence
- Data quality limitations: underreporting, duplicate and narrative-only entries and missing denominators, and how to interpret signals responsibly
- Recalls under 21 CFR Part 806 (corrections and removals) and safety communications: how recalls and safety signals drive CAPA and risk-management updates (ISO 14971)
- Connecting U.S. postmarket work with EU obligations so one global system feeds both MAUDE and MDR PMS / PMCF and vigilance (EUDAMED)
14:30
14:45
Diego Sanoja GarcĂa
- MDUFA V through 30 September 2027: annual fee updates and what to budget for FY2026 and FY2027 submissions
- Small Business Determination to reduce fees, and timing the request before submission
- MDUFA VI on the horizon: negotiations restarted in 2026 and potential changes to programs such as TAP
- Realistic submission planning: Refuse to Accept and review clocks, Additional Information (deficiency) holds, and sequencing
- Operational coordination: FDA establishment registration and device listing, the U.S. Agent and initial importer roles, and aligning distribution partners
15:15
Diego Sanoja GarcĂa
- Breakthrough Devices Program: eligibility for devices that address life-threatening or irreversibly debilitating conditions with unmet need, and the benefits of interactive and priority review with senior FDA engagement
- TAP (Total Product Life Cycle Advisory Program): launched in 2023 under MDUFA V, voluntary, for Breakthrough and STeP devices, with a dedicated TAP advisor and early, frequent, strategic engagement including payers and clinicians
- Current status: phased expansion through FY2027 (up to 325 devices), new review divisions added in 2026 including in vitro diagnostics, the RAPID coverage pathway with CMS for Medicare beneficiaries, and TAP's future under MDUFA VI
- Strategic fit and practical use for EU manufacturers entering the U.S.
16:00
Diego Sanoja GarcĂa
- SaMD scope and the boundary to general wellness software, the IMDRF risk framework, and clinical decision support considerations
- AI/ML-enabled device software functions and the Predetermined Change Control Plan (PCCP): FDA final guidance (December 2024) and the three PCCP elements (Description of Modifications, Modification Protocol and Impact Assessment), staying within intended use, with implementation under the quality system
- Good Machine Learning Practice and transparency: bias management, data representativeness and real-world performance monitoring
- Cybersecurity as a premarket requirement (Section 524B FD&C Act): Secure Product Development Framework, threat modeling and SBOM, integrated into the QMSR / ISO 13485 quality system per the updated February 2026 FDA cybersecurity guidance
16:50
17:00
09:00
Welcome
Welcome
- Participants' expectations and current U.S. projects
09:15
The FDA system from an MDR perspective
The FDA system from an MDR perspective
Christoph Kiesselbach
- Roles: manufacturer, U.S. Agent, importer
- Device classification and regulatory pathway
- 510(k), De Novo and PMA pathways
- eSTAR and common pitfalls
- Leveraging your MDR setup
10:15
Pre-Submission and FDA interaction
Pre-Submission and FDA interaction
Christoph Kiesselbach
- Q-Sub as a planning tool for EU manufacturers
- Avoiding Refuse to Accept decisions
- Strategic FDA interaction
Coffee break
11:15
QMSR in practice: first lessons since February 2026
QMSR in practice: first lessons since February 2026
Christoph Kiesselbach
- What QMSR / ISO 13485 has changed
- Typical weak points: design controls, documentation, CAPA
- Inspection process, expectations and typical weak points
Lunch break
13:00
Clinical data for the FDA
Clinical data for the FDA
Diego Sanoja GarcĂa
- Good Clinical Practice for devices: 21 CFR Part 812 (IDE), Part 50 (informed consent), Part 56 (IRB) and Part 54 (financial disclosure); alignment with ISO 14155 and ICH E6(R3); data integrity and ALCOA+ expectations
- Investigational Device Exemption (IDE): significant-risk versus non-significant-risk determination, the IDE application and approval route for SR studies, abbreviated requirements for NSR studies, and IRB oversight
- When U.S. clinical data is expected: evidence needs across PMA versus 510(k) and De Novo, agreeing endpoints and study design early through the Q-Sub / Pre-Submission program, and U.S. site and IRB considerations
- Using EU (MDR) and other OUS data for FDA: acceptance criteria under 21 CFR 812.28 (GCP conformance, applicability to the U.S. population and medical practice, and FDA ability to inspect), leveraging ISO 14155 investigations, and gap analysis between MDR clinical evidence (CER and PMCF) and FDA expectations
13:50
Postmarket surveillance: MAUDE, recalls and safety signals
Postmarket surveillance: MAUDE, recalls and safety signals
Diego Sanoja GarcĂa
- Mandatory reporting under 21 CFR Part 803 (deaths, serious injuries and malfunctions) and how these events populate the MAUDE database
- Using MAUDE for risk management input, postmarket surveillance and competitive intelligence
- Data quality limitations: underreporting, duplicate and narrative-only entries and missing denominators, and how to interpret signals responsibly
- Recalls under 21 CFR Part 806 (corrections and removals) and safety communications: how recalls and safety signals drive CAPA and risk-management updates (ISO 14971)
- Connecting U.S. postmarket work with EU obligations so one global system feeds both MAUDE and MDR PMS / PMCF and vigilance (EUDAMED)
Coffee break
14:45
Planning for 2027: user fees and operational risk
Planning for 2027: user fees and operational risk
Diego Sanoja GarcĂa
- MDUFA V through 30 September 2027: annual fee updates and what to budget for FY2026 and FY2027 submissions
- Small Business Determination to reduce fees, and timing the request before submission
- MDUFA VI on the horizon: negotiations restarted in 2026 and potential changes to programs such as TAP
- Realistic submission planning: Refuse to Accept and review clocks, Additional Information (deficiency) holds, and sequencing
- Operational coordination: FDA establishment registration and device listing, the U.S. Agent and initial importer roles, and aligning distribution partners
15:15
Breakthrough Devices and TAP
Breakthrough Devices and TAP
Diego Sanoja GarcĂa
- Breakthrough Devices Program: eligibility for devices that address life-threatening or irreversibly debilitating conditions with unmet need, and the benefits of interactive and priority review with senior FDA engagement
- TAP (Total Product Life Cycle Advisory Program): launched in 2023 under MDUFA V, voluntary, for Breakthrough and STeP devices, with a dedicated TAP advisor and early, frequent, strategic engagement including payers and clinicians
- Current status: phased expansion through FY2027 (up to 325 devices), new review divisions added in 2026 including in vitro diagnostics, the RAPID coverage pathway with CMS for Medicare beneficiaries, and TAP's future under MDUFA VI
- Strategic fit and practical use for EU manufacturers entering the U.S.
16:00
Software as a Medical Device: AI/ML, PCCP and cybersecurity
Software as a Medical Device: AI/ML, PCCP and cybersecurity
Diego Sanoja GarcĂa
- SaMD scope and the boundary to general wellness software, the IMDRF risk framework, and clinical decision support considerations
- AI/ML-enabled device software functions and the Predetermined Change Control Plan (PCCP): FDA final guidance (December 2024) and the three PCCP elements (Description of Modifications, Modification Protocol and Impact Assessment), staying within intended use, with implementation under the quality system
- Good Machine Learning Practice and transparency: bias management, data representativeness and real-world performance monitoring
- Cybersecurity as a premarket requirement (Section 524B FD&C Act): Secure Product Development Framework, threat modeling and SBOM, integrated into the QMSR / ISO 13485 quality system per the updated February 2026 FDA cybersecurity guidance
Wrap-up, key takeaways and open Q&A
End of the seminar
Downloads
Request the documents using our form.
Brochure
Abbreviation List: Medical Devices
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