The doctor has noticed an uptick in FDA’s enforcement trend for device manufacturers and other industry professionals associated with the advertising of finished medical devices that are (a) not cleared/approved by FDA or (b) being promoted on websites for off-label uses (e.g., outside of the scope for the cleared/approved intended use). The agency frowns upon these flagrant violators, often moving directly to issuing a warning letter. For establishments with the proverbial “one-trick pony”, the warning letter often equates to the end of the line as a viable device establishment. For those establishments capable of weathering the storm and surviving the 510(k) or PMA process, the regulatory pain will leave fiscal scars. Obviously, the FDA would love to inculcate (look-it-up) device establishments for the need to comply with statutory and regulatory requirements, (e.g., 21 CFR Part 820, a.k.a. Quality System Regulation). However, as you will see when reviewing the warning letter soundbites that Dr. D has selected for this week’s guidance, some establishments just don’t get it. Enjoy!

Warning Letter – 29 May 2015

“FDA has reviewed your firm’s website, http://www.seri.com and determined that the SERI Surgical Scaffold is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C.§ 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).”

Warning Letter – 29 May 2015

“FDA has reviewed your firm’s website, http://www.teibio.com/products/by-brand/surgimend-prs/ and determined that the SurgiMend is adulterated under section 501 (f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The SurgiMend is also misbranded under section 502(o) the Act, 21 U.S.C.§ 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81 (a)(3)(ii).”

Warning Letter – 29 May 2015

“The FDA has reviewed the website, www.consultdrminas.com, and determined that lnterfall Hydrogel products are being marketed as a dermal filler for shaping the face, genitals, mammary glands, and buttocks; elimination of deep deforming scars; and endoprosthetics of vocal chords in cases of paralytic stenosis of the larynx, as well as for a number of other indications. Additionally, Teosyal is being marketed as an aesthetic medicine which is “among the top 3 fillers in the world today.”

Warning Letter – 28 May 2015

“FDA has reviewed a video on your website, http://www.coloncareproducts.com/, and determined that the Colon Hydrotherapy Device is being marketed with general wellbeing and medical claims. For example, your firm makes reference to one of several treatments from your Open System Colon Hydrotherapy Device (Grace), in which a person could see improvements in the following medical conditions:

• remove ‘autotoxins’ associated with the presence of fecal waste material
• psoriasis
• lupus
• multiple sclerosis
• chronic intestinal pseudoobstruction
• congenital dysautonomia
• ovarian cancer
• parasitic infections

A review of our records reveals that your firm has not received clearance or approval before offering this device for sale, which is a violation of the law. Therefore, the Open System Colon Hydrotherapy Device (Grace) is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).”

Warning Letter – 01 June 2015

“FDA has reviewed your firm’s website, http://www.lifecell.com/health-care-professionals/lifecellproducts/stratticetm-reconstructive-tissue-matrix/, and determined that the Strattice Reconstructive Tissue Matrix is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351 (f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The Strattice Reconstructive Tissue Matrix is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution a device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).”

Compliance for Dummies

Folks, we are not talking about any sort of rocket science here. If a device has been cleared or approved for a specific indication, it can only be advertised for that specific indication. If a device has been entered into commerce and the device has not been cleared or approved by FDA, or FDA has no record of the offending device establishment as being registered, bad things are going to happen. Even if a device is considered Class I, an establishment is required to register with the FDA and list the device through the employment of FURLS (FDA Unified Registration and Listing System). Now although FURLS is not the most user-friendly system, navigation does get easier with experience.

Simply stated, establishments wanting to enter finished devices that are safe and effective into commerce in the United States must:

• Register as an establishment with FDA and pay the $3,646.00 (FY 2015 fee);
• List Class I devices using FURLS;
• Submit a 510(k), pay either $2,509.00 or $5,018.00, obtain clearance, and list the Class II device using FURLS; or
• Submit a PMA, pay either $62,724.00 or $250,895.00, receive approval, and list the Class III device using FURLs

Remember, there is always truth in advertising in the device industry. It is imperative that device establishments do not promote off-label use or advertise using unsubstantiated claims. Otherwise, our dear friends from the agency will take the appropriate regulatory action necessary to protect the general health of the American population.

Takeaways

For this week’s guidance there are no takeaways, just one closing thought. The FDA is always watching. In fact, so is your competition, and they are willing and able to report medical device advertising transgressions to a vigilant FDA. 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

Code of Federal Regulation. (2014, 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 (May 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Allergan Medical, Warning Letter. Accessed June 15, 2015. Retrieved from
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449569.htm

FDA (May 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, TEI Biosciences, Warning Letter. Accessed June 15, 2015. Retrieved from
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449557.htm

FDA (May 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Dr. Ashley Minas, Warning Letter. Accessed June 15, 2015. Retrieved from
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449703.htm

FDA (May 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Colon Care Products of PA, Warning Letter. Accessed June 15, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449801.htm

FDA (May 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, LifeCell Corp., Warning Letter. Accessed June 15, 2015. Retrieved from
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449737.htm