We provided the 510(k) information and all required documentation as requested by the review team, but the appeal was still rejected
Hello, I am hoping HAQM can give me some guidance or insight.
Our listing was recently deactivated and HAQM marked it as a medical device for professional use only, which requires a valid 510(k) and other supporting documentation.
case id：17602810381
We submitted
(1) Product packaging 6-sided photos
(2) Product instruction manual
(3) FDA 510(k) number for the product
(4) FDA facility registration number
(5) Device name as shown on the FDA 510(k) number
(6) Purchase invoice to ensure the device was purchased from the manufacturer
Our information was very complete, but despite submitting all the required documentation, we received a rejection from HAQM:
“The FDA 510(k) provided does not cover this product”
We double-checked the FDA database and the 510(k) information matches the product exactly.
It feels like we are stuck in a rut and no one is clearly explaining what information is missing or incorrect.
Any suggestions, contact information, or escalation paths would be greatly appreciated.
Thanks in advance for your help!
We provided the 510(k) information and all required documentation as requested by the review team, but the appeal was still rejected
Hello, I am hoping HAQM can give me some guidance or insight.
Our listing was recently deactivated and HAQM marked it as a medical device for professional use only, which requires a valid 510(k) and other supporting documentation.
case id：17602810381
We submitted
(1) Product packaging 6-sided photos
(2) Product instruction manual
(3) FDA 510(k) number for the product
(4) FDA facility registration number
(5) Device name as shown on the FDA 510(k) number
(6) Purchase invoice to ensure the device was purchased from the manufacturer
Our information was very complete, but despite submitting all the required documentation, we received a rejection from HAQM:
“The FDA 510(k) provided does not cover this product”
We double-checked the FDA database and the 510(k) information matches the product exactly.
It feels like we are stuck in a rut and no one is clearly explaining what information is missing or incorrect.
Any suggestions, contact information, or escalation paths would be greatly appreciated.
Thanks in advance for your help!
5 replies
Seller_HsmlcUwmJdtjI
In fact, whether your review can pass or not has little to do with your information, but more to do with whether the person reviewing the information can understand it. This is a matter of probability
Seller_IB2eaxsRgtWNT
@Manny_HAQM@Atlas_HAQM@Emet_HAQM
Please help me solve the problem I'm facing, I will be very grateful, thank you very much
Seller_IB2eaxsRgtWNT
@Topher_HAQM@Glenn_HAQM@Dougal_HAQM@Blake_HAQM@Sandy_HAQM@Michelle_HAQM@Tatiana_HAQM@Micah_HAQM@Emet_HAQM@CR_HAQM@Emet_HAQM@Manny_HAQM@Atlas_HAQM
Please, everyone, please help me solve my problem. We really have no other solution. I really don’t know where the problem is. I really hope to get help!
Manny_HAQM
Hello @Seller_IB2eaxsRgtWNT,
Thanks for posting here. I've reviewed the details of this request and see that case 17602810381 is currently open with the team who is actively looking into the issue and is providing updates.
Please allow the team time to review this and get back to you with an update. If you see that the case resolves later and still need help, let me know here and I'll look into seeing what options exist for escalation.
Regards,
- Manny