Hello Anon,
Indeed is a rare situation and hopefully the organisation can continue their market access with the new device. For the existing device, there are a couple options can do for the medical device listing and establishment. For the medical device listing, if the company truly no longer sells, markets, or distributes the product, this can be inactivated. Just because products are in the field, does not mean the listing needs to be kept active. For the establishment registration because there are products in the field, customer complaints, etc., the company could either maintain the registration as the "Manufacturer" or change to "maintains complaint files", but in either of those cases, the registration fee still needs to be paid. It is the same price for all of them, which next fiscal year is approaching $10k USD. If the product is re-usable and continued to be used in the field, there is probably not much else you can do from establishment registration perspective.
For the Quality Management System (QMS) this also holds true as well, that certain processes do need to be maintained and supported even if no manufacturing is taking place. However, the scope of those activities can be fairly limited and focused on the current activities done by the company. So processes like complaint management, servicing, corrective action, internal audits, management review, supplier management, would all still need to be done in some fashion. The suggestion is to "update" scope of the QMS until the new products are brought through development - and certainly design controls need to be done. This update would be revising the management review agenda to focus only on say post market activities, internal audits would be done against post market activities, supplier management for any communication of post market issues with the contract manufacturer, etc. It can be managed with a bit of work up front, to help focus on the scope of activities for the next couple years in the organisation.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 07-Aug-2024 12:29
From: Armin Beck
Subject: Company pausing operations
You are still the legal manufacturer regardless of the product status and must maintain the QMS and FDA registration. Post-Market activities are part of your QMS and will feed back into your CAPA system etc. So you need to continue reviewing the effectiveness of the QMS by conducting the Managment Review.
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Armin Beck
CEO
SunTrixConsulting LLC
El Dorado Hills, CA
1-925-212-7683
armin.beck@suntrixmedical.com
Original Message:
Sent: 07-Aug-2024 07:52
From: Anonymous Member
Subject: Company pausing operations
This message was posted by a user wishing to remain anonymous
In my entire 44 years career, I have never run into this situation. My company is a small start up with a single, low risk FDA Class II device, which has been on the market for a few years. We are financially strapped and are planning to pause manufacturing, which is outsourced. This pause most likely will be permanent. We are developing a new product (class II), which is probably at least 2 years out. We do have about 100 devices in the field. These devices are re-usable (e.g. not disposable). We expect to continue to support our customers with regards to service and complaints. What are our obligations with regard to FDA registration and quality system? Would we still be expected to register? What about management reviews and internal audits? Since we rely heavily on consultants, reducing or eliminating the management review and internal audit would save money. Any guidance, recommendations, thoughts are welcome, keeping in mind that our funds are limited. Thank you!