M
Medsearch
Can you please tell me what is the difference between FDA 510(k) summary and statement?
Le Chiffre
Quite Involved in Discussions
I've just revisited this decision and based on comments on this forum and the FDA's website, the summary appears to be the most popular.
Presumably you've read this:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm#link_7
Was here anything more specific you're looking for?
Presumably you've read this:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm#link_7
Was here anything more specific you're looking for?
Michael Malis
Quite Involved in Discussions
The biggest difference is what will be visible to the outsider after 510(k) clearance!
When you do the "summary" - this is the only information that will be visible and your company promise that it will beproducing GMP compl. product.
When you do Statement "you promised to be in Complaince with GMP's within 30 days . Most of MD companies use the summary because not all the activities are completed...
When you do the "summary" - this is the only information that will be visible and your company promise that it will beproducing GMP compl. product.
When you do Statement "you promised to be in Complaince with GMP's within 30 days . Most of MD companies use the summary because not all the activities are completed...
