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510(k) for IVDs 2013
06-07 Nov 2013
Webinar
Home
510(k) for IVDs 2013
Key Topics
Regulatory requirements for 510(k)s
Statute(s) and regulations
When 510(k)s are required
Device classification and predicates
Recent 510(k) changes and requirements including e-Copy and RTA policy
Demonstrating substantial equivalence
Standards and guidance applicable to IVDs
Regulatory requirements for IVDs
How to respond to FDA’s request of additional information
How to address and present performance data and/or clinical data in a succinct, comprehensive manner
How to resolve different opinions between the submitter and FDA reviewer(s)
Who should Attend
R&D
RA
CROs
QA/QC/QS
Contractors/subcontractors
Consultants
Anyone interested in 510(k) matters
Senior management
Read more
Past Events
510(k) for IVDs 2013 - 06-07 Nov 2013, Webinar
(40980)
510(k) for IVDs 2026
Important
Please, check "510(k) for IVDs" official website for possible changes, before making any traveling arrangements
Event Categories
Business:
Innovations, Quality assurance, Risk Management
Education:
Training
Health & Medicine:
Medical device, Medical laboratories, Medical technology
Industry:
Food & Beverages
Science:
Laboratories
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