Is it possible to obtain FDA clearance (510k) without meeting QSR?

[scda0505]

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?

 

[shimonv]

It doesn't work. No serious organization will buy a DHF from an organization without QMS. Most likely, you will end up building and backdating QMS and missing records. Backdating is illegal.
Do it right from the beginning and develop your QMS in parallel to product development.

Shimon

 

[scda0505]

It doesn't work. No serious organization will buy a DHF from an organization without QMS. Most likely, you will end up building and backdating QMS and missing records. Backdating is illegal.
Do it right from the beginning and develop your QMS in parallel to product development.

Shimon

This reads like an opinion. Can you please cite some supporting regulation? The FDA's 510k checklist does not indicate you must have a QMS.

I do believe one should have a QMS in place, however, this appears to only be an opinion / best practice, not a requirement from what I can find. I'm trying to find where the regs explicitly state you must have a QMS.

There is no need to post date or do anything wrong. You write the DDP, sign and date it, then execute it; all under 820.30. The DDP will need to contain the design control procedure content versus having QMS procedures.

I also disagree that no organization would buy it. Are you of the age that can remember paper based binder DHFs?

 

[shimonv]

scda0505,
I am older than I look and I've done such projects in the past, and I'm no stranger to paper based DHF.
A typical 510k clearance letter says "[...] You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- 542 of the Act); 21 CFR 1000-1050."

Design controls is not a miniature self-contained QMS; it interacts with the other sub-system.

Theoretically it's possible, but practically - not recommend.

Shimon

 

[mihzago]

If a company is new and has no products on the market, then requirements from parts 803, 806, 807 and some areas of the QSR don't really apply because the company has not marketed any products yet and has very limited operations.

While important and certainly a good idea, QMS compliance is far from a show-stopper for investors, unless it's a higher risk product. And, for a 510(k) or De Novo submission, you certify compliance with Design Controls, not the entire QMS.

There are many start-up that obtained a 510(k) without a QMS in place. For some it's a business strategy to obtain clearance with no plans to market the device.

 

[Orca1]

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)).