AdvaMed: 510(k) Submissions


Industry experts and key personnel from the FDA CDRH 510(k) staff (invited) are coming together to discuss 510(k) submissions.  Topics to be covered during this interactive workshop include:

– FDA’s updates to the 510(k) process
– Different types of 510(k)s
– Considerations for determining a product’s regulatory route to market
– Factors to consider when planning and assembling a 510(k) submission
– Tips and hints on interacting with FDA during the 510(k) review process
– Deciding when to submit a new 510(k) for a device modification
– And more