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588K members
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New Seller Community

588K members
3.5K discussions
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Seller_eXcwSrIWrI9O9

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?

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0 replies
Tags:Compliance, Listing deactivated
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Seller_eXcwSrIWrI9O9

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?

52 views
0 replies
Tags:Compliance, Listing deactivated
00
Reply
0 replies
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Seller_eXcwSrIWrI9O9

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?

52 views
0 replies
Tags:Compliance, Listing deactivated
00
Reply
user profile
Seller_eXcwSrIWrI9O9

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?

52 views
0 replies
Tags:Compliance, Listing deactivated
00
Reply
user profile

HELP: De Novo (Predicate for 510k Products) Granted Product Listings being blocked, Seller Support repeatedly ask for 510(k) Number

by Seller_eXcwSrIWrI9O9

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?

Tags:Compliance, Listing deactivated
00
52 views
0 replies
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