FD&C Act / 21 CFR Parts 801, 803, 806, 807, 812, 814, 830
USA Medical Devices Regulatory Requirements
Who it’s for
Who should attend
Regulatory affairs staff preparing US submissions, product and project managers, US agents, quality staff supporting submissions and post-market reporting, and manufacturers entering the US market.
Curriculum
Course modules
- FDA structure, the FD&C Act and the CDRH
- Device definition, classification, product codes and regulation numbers
- Establishment registration and device listing: 21 CFR Part 807
- Premarket Notification 510(k): content, substantial equivalence, predicates
- De Novo classification requests
- Premarket Approval (PMA): 21 CFR Part 814; Humanitarian Device Exemption
- Investigational Device Exemption: 21 CFR Part 812
- Labelling: 21 CFR Part 801; Unique Device Identification: 21 CFR Part 830 and GUDID
- Medical Device Reporting: 21 CFR Part 803
- Corrections and Removals: 21 CFR Part 806; recalls
- Import requirements, US Agent, and foreign manufacturer obligations
- Advertising and promotion; enforcement actions and Warning Letters
Outcomes
What you’ll be able to do
- Determine the correct US market access pathway for a device
- Assemble the content expected in a 510(k) or PMA
- Understand ongoing US post-market reporting obligations
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “USA Medical Devices Regulatory Requirements”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.