Featured Product In Submissions and Approvals
FDA Oversight of Laboratory-Developed Tests — The Impact of the Final Rule
$249.00
Learn from a prominent regulatory expert how to optimize your LDT applications to help secure a 510k clearance or premarket approval. Read More
Submissions and Approvals
The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval – Webinar Recording/Transcript
$287.00
Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript
$287.00
Medical Device Premarket Review Pathways and FDA Mechanisms for Expedited Review – Webinar Recording/Transcript
$287.00
Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis – Webinar Recording/Transcript
$337.00
Medical Device Cybersecurity: Understand the Latest Developments – Webinar Recording/Transcript
$287.00
EU-MDR’s Growing Pains: Are You Current with the Latest Developments? – Webinar Recording/Transcript
$287.00
Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript
$287.00
Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up – Webinar Recording/Transcript
$287.00
Real-World Evidence in Medical Device Submissions: What Regulatory, Compliance & Quality Professionals Need to Know – Webinar Recording/Transcript
$287.00