One of the most basic covenants that all device establishments are required to comply with is the need to register as an establishment with FDA. In the eyes of the agency, if a device establishment fails to register with the FDA, all of the devices manufactured are considered misbranded for failure to comply with Section 510 of the Act, 21 U.S.C. §360. Compliance with the establishment registration process includes foreign device establishments, too. Simply stated, FDA owns the sandbox so FDA can set the rules. Now granted, racking up a passel (look-it-up) of Form 483 observations will typically result in a warning letter. Failure to register as an establishment coupled with nine Form 483 observations, and the Chief Jailable Officer (CJO) is in for some very dark days. Enjoy.
Warning Letter – February 4, 2016
The FDA visited the offending establishment for three days in November 2015. Based on the number of Form 483 observations identified during such a brief inspection, there is no doubt in Dr. D’s mind that the investigator was not in the United Kingdom for bangers and mash. Nine Form 483 observations are always going to be a serious concern for the FDA. However, failure to register and pay establishment fees is a serious sin in the eyes of FDA. How serious you ask? Can you say “detention without physical examination?” Essentially the FDA is refusing entry of this establishment’s finished devices into the United States. Additionally, the agency will place the finished devices manufactured by the offending establishment into detention hold until corrections are made, including the writing of that check to good ol’ Uncle Sam for the establishment registration fees.
Warning Letter Excerpt
“Under section 510 of the Act, 21 U.S.C. §360, manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2016.
Therefore, all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C.§352(0), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).
Given the serious nature of the violations of the Act, the devices manufactured by your firm, including the Helica Thermal Coagulator and the Helica LT/LTC Probes, are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.”
Compliance for Dummies
There really isn’t much the doctor can say about an establishment failing to pay establishment registration fees. Each year there is a three-month window (October 1–December 31) in which establishment registration should occur –including the payment of fees. For FY 2015, the fees were $3,646; this year, the fees were $3,845; and for FY 2017, the proposed fees are an estimated $3,872. According to FDA: “owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA.” Device manufacturers (foreign and domestic), contract manufacturers, sterilization facilities, and device importers and exporters are required to register as an establishment and pay the fee. Simply stated, pay to play baby!
There are other ramifications associated with a failure to register and pay fees as well. For example, the FDA will not accept 510(k)’s or PMA’s for review, sign Certificates to Foreign Governments, or permit the listing of devices into FURLS. In fact, failure to register and pay the fee will seriously impact a device establishment’s revenue stream and product pipeline. If you do not believe Dr. D, just reach out to the CJO of the offending establishment that is the subject of this week’s Devine Guidance (DG). Just remember, the FDA has the ability to unleash some serious regulatory pain to force offending device establishments to comply.
For this week’s guidance, the doctor will leave the readers with just one takeaway: Please do not be that establishment that fails to register with FDA and pay the establishment registration fee. The FDA gives establishments three months, which is a quarter of a year, to register and pay, so there should never be any excuses. In closing, thank you again for joining Dr. D, and the doctor hopes 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. (April 2015). 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. (February 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Berwickshire Electronic Manufacturing, Ltd. Accessed June 26, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506423.htm