A
ascherp
Hello,
Purchasing all rights for manufacture of a medical device involves the transfer of many documents to the new owner. The medical device in question is a Class II device that is sold worldwide and that has been cleared by a 510(k).
I am concerned about the documents that the new owner needs to request from the original 510(k) owner to cover all FDA requirements should the firm ever be inspected and have come up with the following list:
1) DMF, DHF
2) DMR, DHR
3) 510(k) submission file
4) Customer complaints and followup
5) Nonconformances / CAPAs
6) Any design / labeling / material etc. changes post 510(k) clearance date, including rationale for not submitting a new 510(k)
7) MDR events
8) Manufacturing processes, work instructions etc.
9) List of suppliers and incoming product testing instructions
10) Sterilization and packaging validations / supplier lists (for single use components)
11) Biocompatibility test results
12) Validation reports of end user processing instructions (for reusable components)
13) Performance testing protocols and results
Am I missing anything? I'd appreciate your opinion(s)!
Best regards
Purchasing all rights for manufacture of a medical device involves the transfer of many documents to the new owner. The medical device in question is a Class II device that is sold worldwide and that has been cleared by a 510(k).
I am concerned about the documents that the new owner needs to request from the original 510(k) owner to cover all FDA requirements should the firm ever be inspected and have come up with the following list:
1) DMF, DHF
2) DMR, DHR
3) 510(k) submission file
4) Customer complaints and followup
5) Nonconformances / CAPAs
6) Any design / labeling / material etc. changes post 510(k) clearance date, including rationale for not submitting a new 510(k)
7) MDR events
8) Manufacturing processes, work instructions etc.
9) List of suppliers and incoming product testing instructions
10) Sterilization and packaging validations / supplier lists (for single use components)
11) Biocompatibility test results
12) Validation reports of end user processing instructions (for reusable components)
13) Performance testing protocols and results
Am I missing anything? I'd appreciate your opinion(s)!
Best regards