With a few exceptions, Class I and a small quantity of Class II devices are generally exempt from the premarket notification process. In fact, this information is not unlike the GIECO commercial and the commercial’s tag line we are bombarded with daily: “Everyone knows that.”
Unfortunately, device establishments are tasked with identifying the correct classification of their devices and contacting FDA for clarification and/or guidance if they are unsure about the need to file a 510(k) in accordance with Part 807. Additionally, the indications for use better align with the device classification selected. For example, if a device establishment selects 21 CFR 890.5225 (cited in this week’s warning letter), which states the intended use is “to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation” then the establishment cannot state the device is employed for “advanced kinetic therapy…for aggressive treatment of pulmonary complications.”
People, in the eyes of FDA (and Dr. D’s as well), the stated intended uses, denoted in the previous sentence are different. This will definitely garner the attention from the good folks at the agency. Failure to correctly classify a device and then choose to enter the device into commerce will result in much regulatory pain being unleashed from FDA including some level of “obloquy” (look-it-up) raining down from the agency. Enjoy.
Warning Letter – 18 September 2014
Now Dr. D will generally give device establishments the benefit of doubt when making an occasionally error that may result in a Form 483 observation. As the regulatory environment in the medical device industry grows more complex, it becomes easier (hopefully not too easy) to make mistakes. However, misclassifying a medical device is not a mistake to be taken lightly. The best advice Dr. D can offer is to ensure the intended use of the device is in alignment with the classification selected. When in doubt, call FDA and seek their guidance.
For this week’s guidance, the doctor thought that a warning letter pertaining to the incorrect classification of a medical device may have some value for the readers. However, Dr. D’s interest in a warning letter is increased significantly when words like “refused” are used in the body of the warning letter. Refusing to furnish or give the agency requested information is always going to end badly and result in additional regulatory pain, such as this warning letter. Even if a device is exempt from the pre-market notification process, the regulation will still require some controls be put into place; e.g., special controls in the case of 21 CFR 890.5225. However, Class II devices are not exempt from GMP requirements.
Warning letter excerpt
“Because there is evidence that the RotoRest Delta Therapy System, the RotoProne Therapy System, and the TriaDyne Therapy System are intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5225,it exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification.
Our inspection also revealed that RotoRest Delta Therapy System, the RotoProne Therapy System, and the TriaDyne Therapy System are misbranded under section 502(t)(2) of the Act 21 USC 352(t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “QP-21-01-AH, Global Adverse Event and Incident Reporting Process” dated 7/22/2013, the following issues were noted:
1. QP-21-01-AH does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a. Instructions for how to obtain and complete the FDA 3500A form.
b. The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
2. QP-21-01-AH does not describe how your firm will address documentation and record-keeping requirements, including:
a. Documentation of adverse event related information maintained as MDR event files.
b. Information that was evaluated to determine if an event was reportable.
c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
d. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.”
Class II Devices
“The Food and Drug Administration (FDA) has also published a list of class II (special controls) devices (those devices are annotated as “(II)”), subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act. Class II devices are annotated “(II)”. Please note that class II devices are NOT exempt from GMP requirements.”
Compliance for dummies
As you can tell from this week’s warning letter, the investigators did not like this establishment’s SOP for Medical Device Reporting. However, Dr. D seldom, if ever, sees a warning letter issued for just one poorly written SOP. Obviously, the doctor or the readers were not at this establishment during their inspection so something else must have seriously gone wrong for the agency to move so quickly to warning letter. It was probably the misbranding issues; however, a refusal to furnish comment can be equated to pouring gasoline unto an already lit fire. No good can ever come from the failure or refusal to furnish information to FDA.
Additionally, if your establishments manufacture Class II exempt products, the doctor strongly suggests that the procedures necessary to support and maintain GMP are in place, including documented evidence of compliance. It will be the Chief Jailable Officer’s (CJO) neck sticking out when FDA decides to show up on your doorstep for that friendly cup of coffee and an inspection. Finally, it appears that the FDA determined that the product mentioned in this week’s warning letter was not exempt from the pre-market notification process. Can you say recall (Dr. D’s favorite 6-letter word)?
For this week’s guidance the doctor will leave the readers with just one takeaway, determining device classification is an extremely important task. If the device establishment has some concerns over the selection of the correct classification, it is acceptable to ask FDA for guidance. Besides, your organizations are paying for this support through your annual establishment registration fees.
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.
- Code of Federal Regulation. (2013, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- 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, September). FDA.gov Website. Retrieved September 30, 2014, From http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm415503.htm.