If someone wanted to design a device and obtain clearance only to immediately sell it to another legal manufacturer. Is it possible to obtain FDA
510k clearance on a medical device product following FDA 820.30 and not have a quality system in place (meeting the rest of the QMS)? The DHF would be a paper-based binder with wet signatures.
What if the classification was de novo?
It is not possible to obtain FDA 510(k) clearance on a medical device product following FDA 820.30 without having a quality system in place that meets the rest of the Quality Management System (QMS) requirements. The Quality System (QS) Regulation requires manufacturers to establish and follow quality systems to ensure that their products consistently meet applicable requirements and specifications (FDA CP 7382.845, A. THE QUALITY SYSTEM (QS) REGULATION, 3).
For a de novo classification, FDA may inspect relevant facilities to determine if the implementation of Quality System Regulation (part 820 of this chapter) requirements, in addition to other general controls and any specified special controls, provide adequate assurance that critical and/or novel manufacturing processes produce devices that meet specifications necessary to ensure reasonable assurance of safety and effectiveness (21 CFR 860.240(c)).
Regarding the Design History File (DHF), it should document or reference the documentation of the activities carried out to meet the design plan and requirements of Sec. 820.30. A DHF is necessary for each type of device developed (Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation, 61 FR 52602 (V)(C)(91)). The complete history of the design process should be documented in the DHF (Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation, 61 FR 52602 (V)(C)(92)).
If you want to sell the device to another legal manufacturer after obtaining clearance, you must ensure that the FDA-assigned premarket submission number of the cleared premarket notification is included in the device listing (21 CFR 807.25(g)(4)).