Regulatory Open Forum

Dear Regulatory Colleagues,

if Company A got clearance on their device (Class II)  and immediately after clearance before commercialization sold the FDA cleared product to Company B.

Does Company B need to file another 510(K)? 
What will be the responsibilities of Company A and B from Compliance Perspective?

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

All is explained in this article, Bhupinder: https://www.donawa.com/european-cro/files/Who%20owns%20the%20510(k).pdf.

While this is nearly 10 years old, the information it contains is still current and valid. The last few paragraphs of the article address the situation you are asking about.

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Rome, Italy
+39 06 578 2665
rgray@donawa.com
------------------------------

Original Message:
Sent: 06-Sep-2017 16:55
From: Bhupinder Singh
Subject: Requirements for Manufacturer after buying 510(k) clear Product

Dear Regulatory Colleagues,

if Company A got clearance on their device (Class II)  and immediately after clearance before commercialization sold the FDA cleared product to Company B.

Does Company B need to file another 510(K)?
What will be the responsibilities of Company A and B from Compliance Perspective?

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Also Company A should de-list the products from the FDA device listing database and Company B should immediately add it.

------------------------------
John Minier, RAC
Consultant, Principal
Minier Medical Device Consulting
john@johnminier.com
1(914)850-4432
Highland Mills, NY
United States
------------------------------

Original Message:
Sent: 06-Sep-2017 16:55
From: Bhupinder Singh
Subject: Requirements for Manufacturer after buying 510(k) clear Product

Dear Regulatory Colleagues,

if Company A got clearance on their device (Class II)  and immediately after clearance before commercialization sold the FDA cleared product to Company B.

Does Company B need to file another 510(K)?
What will be the responsibilities of Company A and B from Compliance Perspective?

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Thank You John and Roger for your Support!
Appreciate your time!

Bhupinder Singh

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Original Message:
Sent: 06-Sep-2017 16:55
From: Bhupinder Singh
Subject: Requirements for Manufacturer after buying 510(k) clear Product

Dear Regulatory Colleagues,

if Company A got clearance on their device (Class II)  and immediately after clearance before commercialization sold the FDA cleared product to Company B.

Does Company B need to file another 510(K)?
What will be the responsibilities of Company A and B from Compliance Perspective?

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------