HELP: De Novo (Predicate for 510k Products) Granted Product Listings being blocked, Seller Support repeatedly ask for 510(k) Number
Hello,
We're facing a unique situation and could use the community's insights. Our company received FDA De Novo authorization. However, we're having difficulty getting Amazon's approval for listing, Seller Support insists on 510(k) Number.
The challenge seems to be that Amazon's system is set up for 510k approvals, but De Novo is actually a higher-level FDA authorization that creates the pathway for future 510k submissions.
Key Points:
- FDA De Novo authorized (not 510k) as it's creating a new device category
- FDA officially annouced
Current Status:
- ASINs have been blocked for a month
- Submitted 17 cases including appeals
- 3 cases escalated a week ago
- Provided FDA announcement, De Novo database links, all documentation
Has anyone dealt with De Novo authorized products before? Any suggestions on reaching the right team at Amazon?
HELP: De Novo (Predicate for 510k Products) Granted Product Listings being blocked, Seller Support repeatedly ask for 510(k) Number
Hello,
We're facing a unique situation and could use the community's insights. Our company received FDA De Novo authorization. However, we're having difficulty getting Amazon's approval for listing, Seller Support insists on 510(k) Number.
The challenge seems to be that Amazon's system is set up for 510k approvals, but De Novo is actually a higher-level FDA authorization that creates the pathway for future 510k submissions.
Key Points:
- FDA De Novo authorized (not 510k) as it's creating a new device category
- FDA officially annouced
Current Status:
- ASINs have been blocked for a month
- Submitted 17 cases including appeals
- 3 cases escalated a week ago
- Provided FDA announcement, De Novo database links, all documentation
Has anyone dealt with De Novo authorized products before? Any suggestions on reaching the right team at Amazon?
