Folks, Dr. D would like to begin this week’s guidance by reminding the readers that Class I or Class II devices identified as exempt are not exempt from having a recognizable quality management system (QMS) or at least key pieces of one. Seriously, the exempt pertains to the premarket notification procedure that is delineated within 21 CFR, Part 807. In short, no premarket approval application and subsequent device clearance is required by the FDA. Can you say a 510(k) is not required?

My dear friend and evil twin, Jim Twitchell (VP of Quality at Avinger), suggested that I share a warning letter issued to the manufacturer of a Class II Exempt device (Part 880 – Section 880.6740) being manufactured by an establishment located in Iowa. The doctor is seldom surprised at the ease and “celerity” (look-it-up) exuded by the FDA when issuing a warning letter to an establishment that fails to comply with significant portions of the Quality System Regulation (QSR) or in the case of this week’s subject, an establishment that has failed to implement a QMS that complies with the QSR.

FDA warning letter – 16 May 2014

When an agency warning letter begins with the phrase; “Your firm lacks quality system procedures and instructions, as required by 21 CFR, Part 820.20(e)” bad news is about to be dropped into the lap of an offending establishment’s chief Jailable officer (CJO), if they have one. Otherwise, the CEO is about to have his or her day ruined.

820.20(e) Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.

Referring back to the opening paragraph, this manufacturer must have thought that they were exempt from having a QMS. If this organization actually took the time to review the requirements associated with their specific device classification (Regulation 880-6740 / Product Code KDQ) they would have noticed that the manufacturers of these types of devices are not exempt from complying with GMP requirements. Dr. D cannot come up with any plausible explanation for a device establishment not taking the time to establish written procedures to support their QMS when such requirements are dictated by regulation. Maybe this establishment did not understand the FDA’s terms: “Special Controls” or “GMP Exempt – No?” Regardless, this organization was awarded with a warning letter documenting the following QMS-related issues:

1. Failure to ensure the presence of identification labels on each suction canister and lid, and on each kidney transport tray, as required by 21 CFR 820.60. Although your firm places a “serial number” on the outside of each cardboard box the medical devices are packaged in, once the device is removed from the cardboard box, you no longer have any way to link the device to even this number.
2. Failure to establish Device Master Records and Device History Records containing the required information for both the suction canister and lid, and the kidney transport tray, as required by 21 CFR 820.181 (Device Master Records) and 21 CFR 820.184 (Device History Records). While your firm has a Device Master Record for the suction canister and lid, it lacks certain required information such as, but not limited to, updated drawings, quality assurance procedures and specifications including acceptance criteria, and label specifications. The production sheet which your firm recently began using as a Device History Record for the suction canister and lid fails to contain the required information such as, but not limited to, the primary identification label, and specifications and testing data to ensure the device meets specifications. Your firm has neither a Device Master Record nor a Device History Record for the kidney transport trays.
3. Failure to establish acceptance activities for receiving incoming raw materials used in the manufacture of the suction canister and lid, and kidney transport tray, as required by 21 CFR 820.80(b). Your firm has no testing activities or procedures for testing and evaluating raw materials and no acceptance criteria for raw materials.
4. Failure to establish acceptance activities for the in-process and finished suction canister and lid, and kidney transport tray, as required by 21 CFR 820. 80(c) (in-process device) and 21 CFR 820.80(d) (finished device). Your firm has no testing activities or procedures for testing and evaluating in-process and finished devices and no acceptance criteria for in-process and finished devices.
5. Failure to document evaluation or quality requirements of suppliers or vendors, as required by 21 CFR 820.50(a). Your firm has not evaluated your suppliers’ ability to provide materials of adequate quality used to manufacture medical devices such as suction canisters and lids, and kidney transport trays. Further, your firm has no quality agreements in place with your suppliers or vendors. 6. Failure to ensure manufacturing equipment is calibrated, as required by 21 CFR 820.72(b). Your firm has failed to calibrate the scale used in the production of your firm’s medical devices such as the suction canisters and lid s, and the kidney transport trays.”

Compliance for dummies

Special Controls is the agency’s way of granting some dispensation in regards to elements of the QSR that apply to the manufacturers of Class I and Class II Exempt devices. Generally speaking, special controls coupled with GMP exempt require establishments to: (a) maintain an effective recordkeeping system; (b) comply with product labeling requirements (Part 801); (c) establish a system for the management of complaints; and (d) comply with Part 803 and 806 requirements (as applicable). However, when special controls are identified and GMP requirements are not exempt, device establishments must actually comply with GMP requirements. For example, the FDA actually expects manufacturers of Class II Exempt devices to actually design, develop, and enter into commerce a device that is safe and effective in its intended use. Hint – this is not earth-shattering news. Additionally, the FDA expects establishments manufacturing Class I and Class II Exempt devices that are not exempt from GMP requirements to comply with (requirements denoted in this week’s warning letter):

• §820.181 Device Master Record (DMR);
• §820.184 Device History Record (DHR);
• §820.60 Identification;
• §820.80 Receiving, In-process, and Finished Device Acceptance;
• §820.50 Purchasing Controls;
• §820.72 Inspection, Measuring, and test Equipment; and
• §820.198 Complaint Files.

Furthermore, the agency expects labeling to be in accordance with 21 CFR, Part 801; MDRs to be filed in accordance with Part 803; and recalls to be processed in accordance with Part 806 (as appropriate). Finally, it is up to the establishment, not the FDA, to ensure product classifications are clearly understood, with the appropriate procedures established to support claims of compliance.

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway. It is incumbent upon your organizations to ensure that the classifications of devices entered into commerce are properly classified and the applicable QMS requirements understood and implemented. Class I or Class II exempt has nothing to do with the actual QSR requirements and pertains only to the regulatory pathway. Individual device classifications denoted within 21 CFR, Parts 862 through 892 will delineate the actual requirements as they pertain to level of compliance with GMP (exempt or not exempt). In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.

References

1. Code of Federal Regulation. (2013, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, August). FDA.gov Website. Retrieved August 10, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm407071.htm