Syllabus
US Medical Device Premarket Submissions Professional Certificate
37 lessons, about 14 hours. Online and self-paced, with a certificate when you finish.
FDA Device Status and Pathways
Learners establish device regulatory status, identify the correct FDA classification and jurisdiction, and select defensible premarket pathways and 510(k) submission types.
- 1Medical Device Status and Software Exclusions
- 2Intended Use and Combination Product Jurisdiction
- 3FDA Classification and Product Code Research
- 4510(k), De Novo, and PMA Selection
- 5Traditional, Special, and Abbreviated 510(k)
Predicate Strategy and Substantial Equivalence
Learners find legally marketed predicate candidates, defend predicate suitability, and construct a traceable substantial-equivalence argument supported by relevant scientific evidence.
- 6FDA Predicate Database Research
- 7Predicate Suitability and Safety Assessment
- 8Substantial Equivalence Decision Rules
- 9Substantial Equivalence Matrix and Evidence Mapping
FDA Pre-Submission Strategy
Learners determine when FDA feedback is useful, prepare a focused Pre-Submission, and translate agency interactions into documented development and submission decisions.
- 10Pre-Submission Triggers and Regulatory Questions
- 11Pre-Submission Briefing and PreSTAR Preparation
- 12FDA Meeting and Feedback Management
Technical Evidence and Quality Systems
Learners develop risk-based evidence plans incorporating nonclinical testing, biological safety, software, cybersecurity, human factors, clinical evidence, and the 2026 Quality Management System Regulation.
- 13Risk-Based Verification and Validation Planning
- 14Nonclinical Testing and GLP Applicability
- 15Biocompatibility and FDA Standards Recognition
- 16Device Software Documentation and Verification
- 17Cybersecurity Documentation and Software Bill of Materials
- 18Human Factors and Clinical Evidence Planning
- 19Clinical Investigation Protections and Regulatory Disclosures
- 20QMSR Design and Development Records
eSTAR 510(k) Submission Construction
Learners assemble and audit the administrative, technical, labeling, predicate, and evidence components of a simulated eSTAR-ready 510(k) submission.
- 21eSTAR Template Navigation and Version Control
- 22510(k) Administrative Statements and Certifications
- 23Indications, Labeling, and 510(k) Summaries
- 24Device Description and Predicate Comparison Sections
- 25Technical Evidence and Attachment Assembly
- 26eSTAR Completeness and Cross-Functional Audit
- 27Simulated eSTAR 510(k) Package Finalization
De Novo and PMA Applications
Learners evaluate De Novo eligibility, prepare required-content maps, distinguish PMA evidence requirements, and select appropriate PMA submission and supplement formats.
- 28De Novo Eligibility and Classification Rationale
- 29De Novo eSTAR Content and Evidence Map
- 30PMA Evidence and Application Architecture
- 31PMA Formats and Supplement Pathways
Submission Operations and FDA Review
Learners plan electronic submission delivery and user fees, distinguish FDA review stages, and manage technical-screening holds and substantive deficiencies.
- 32FDA Electronic Submissions and FY2027 Fees
- 33FDA Screening and Deficiency Response Workflow
Device Change Control and Capstone
Learners apply regulatory modification decision frameworks to physical and software changes, evaluate PMA reporting obligations, and demonstrate integrated premarket regulatory judgment.
- 34New 510(k) Requirements for Device Changes
- 35Software Modifications and Authorized Change Plans
- 36PMA Change and Supplement Determinations
- 37Integrated Medical Device Regulatory Decision Capstone