Folks, while taking my weekly stroll through the unfortunate establishments blessed with the receipt of agency warning letters, Dr. D came across a warning letter that cites failure to comply with 21 CFR, Part 1002 (Records and Reports) requirements. The reason the doctor is bringing this issue up is that it is unusual for a device establishment to receive Form 483 observations for reporting issues, or should Dr. D say, the failure to report. Hopefully, by now (several years after it was rescinded) regulatory and quality professionals recognize that baseline reporting and annual certification requirements are no longer required by FDA. However, premised on the warning letter Dr. D has selected for this week’s guidance, apparently not everyone got the message. In fact, there is no doubt in Dr. D’s mind; the Chief Jailable Officer (CJO) on the receiving end of this week’s warning letter was probably not ready for the level of “dyspepsia” (look-it-up) suffered at the expense of the FDA investigator. Enjoy!

Warning Letter – 20 February 2015

For those of you not familiar with 21 CFR, Part 1002; it requires device establishments to file an initial report with FDA prior to releasing approved/cleared product into commerce and the filing of an annual report with FDA. In fact, the record and reporting requirements are clearly spelled out in Table 1 of Part 1002. If an establishment has questions or concerns pertaining to the requirement, please pick up the phone and speak with FDA. Dr. D has done so on multiple occasions and the FDA has always been extremely helpful. That being said, the establishment awarded this warning letter clearly missed the proverbial boat. Not only was their procedure still referencing the baseline reporting requirement rescinded many, many, moons ago; they were not adhering to the current requirements for reporting, as established by FDA.

Now granted, depending on the size of an establishment’s product portfolio, an occasional reporting hiccup is bound to occur. However, not reporting and then providing the FDA with a deficient response will result in very bad things happening to this establishment. For those of you that read Devine Guidance weekly, you already may have an inkling that Dr. D is clairvoyant. In fact, the doctor has just gazed into his crystal ball and noticed a CJO in tears, reading a document entitled “WARNING LETTER.” You will have to stop back next week to find out who the lucky recipient is going to be.

Warning Letter Excerpt

Observation Seven: “Failure to submit a product report prior to the introduction of the product into commerce, as required by 21 CFR 1002.10. For example, your firm has not submitted a product report for the X70 dental X-ray devices (wall-mounted and mobile style) prior to introduction into commerce.

The response dated 10/20/14 is inadequate. Your firm’s response indicates that they filed the product report immediately after the inspection, but does not address how your firm will handle product reports going forward.”

Observation Eight: “Failure to submit an annual report as specified in table 1 of 1002.1 and required by 21 CFR 1002.13. For example, your firm has not submitted an Annual report for the X70 dental X-ray devices (wall-mounted and mobile style), which is due by September 1, and shall cover the 12-month period ending on June 30 preceding the due date of the report.

The response dated 10/20/14 is inadequate. Your firm’s response indicates that they filed the annual report immediately after the inspection, but does not address how your firm will handle annual reports going forward.”

Compliance for Dummies

Not wanting to state the obvious but obliged to do so, Dr. D always recommends scripting a procedure for record and reporting requirements. Yes, the need to provide reports to FDA should be second nature to establishments; however, as the doctor previously mentioned hiccups do occur. The doctor recommends creating your own Table 1 that lists your establishments products (or product families) and the specific reporting requirements for each one. Seriously, translating Table 1 of Part 1002, to make it user friendly, is just the smart thing to do. Part 1002 also delineates the requirements for dealers and distributers. The pragmatic approach for the handling of dealers and distributors is to ensure the record and reporting requirements find their way into signed quality agreements and contracts. Why? If an establishment does not spell out its dealer and distributer requirements in writing, there is limited recourse if these same dealers and distributers fail to adhere with Part 1002.

Additionally, ensure you reference the “correct” FDA address. Now granted, FDA does not change addresses in their regulatory documents too terribly often, but occasionally they do. There is nothing more embarrassing for a CJO, then providing an investigator with a document that contains obvious errors, i.e., wrong address, rescinded requirements, etc. (just ask the CJO that was the recipient of this week’s warning letter).

Furthermore, the format for reports required under Part 1002 is left up to the establishment; providing everything required by Part 1002 is placed into the report and the FDA can navigate through the report quickly and identify the required information. The good news is, once your organization scripts a report format that they are comfortable with, revising the information once each year or issuing an initial report for new products really does become that proverbial cakewalk.

Finally, and the doctor sees this issue time and time again, do not forget to sign the report(s)! Seriously, stuff happens; however, the FDA really does want to know the name of the individual submitting these reports and have their signature on file (§1002.7).

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway. Folks, we all work in the medical device industry and if you work in the device industry in the United States and introduce FDA approved/cleared product into commerce in the United States, then it is incumbent upon the device establishment to play by the FDA’s rules. Remember, if you are playing in FDA’s sandbox, then you must play by FDA’s rules; “pretty simple concept, right?” The need to provide reports in accordance with Part 1002 is probably one of the easier agency requirements to comply (Dr. D’s opinion). An initial report and then an annual report, as long as the product is being introduced into commerce. It is so easy, a cave man can do it (thank you GEICO)!

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. (2014, 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.
4. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March16, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436701.htm.