So you’ve identified your company’s device in the Code of Federal Regulations somewhere between parts 862 to 892. And the classification provides even better news- Class I or Class II device exempt from premarket notification. Hurray, you’re off to the races, right? Not so fast. Let’s take a moment to read the full text of the Classification and understand it’s limitations, especially with respect to marketing claims.

 

For our purposes here, let’s say that our device is a Physical Medicine Device, say an intermittent pressure measure system, a Class I device according to 21 CFR 890.1600.(1) The device is subject to general controls and “exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9.” Subpart E of part 807 describes various premarket notification procedures from which your intermittent pressure measure system is exempt. But what are the “limitations in 890.9” that the device is subject to?

 

 

The pertinent portion of Sec. 890.9 reads as follows (emphasis added):(2)

The exemption from the requirements of premarket notification (section 520(k) of the Act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

the device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose or the device is intended for lay use where the former intended use was by health care professionals only;

 

Changes to the intended use of a device may activate this limitation of the exemption. For example, the device premarket notification exemption under 21 CFR 890.9(a) may be lost if a company markets the device directly to consumers, if a company does not require a physician’s prescription to obtain and use the device, if a company intends that he device be used by lay persons instead of health care professionals or in some manner intends the use to be different than the legally marketed device.

 

Exceeding the limitations of 21 CFR 890.9(a) requires premarket notification. Marketing of a device without such premarket notification makes the devices adulterated under 21 USC §351(f)(1)(B) and misbranded under 21 USC §352(o).

 

So is the FDA enforcing this provision and how has this played out? FDA enforcement actions based on activities exceeding the limitations of 21 CFR 890.9(a) are summarized below.

 

In a 2005 Warning Letter, the company, IFC International, had problems cited against its Arianna BABY-Vac Nasal Vacuum.(3) This device was classified as a vacuum-powered fluid suction apparatus under 21 CFR 880.6740 as a class II device exempt from premarket notification. The FDA agreed that the device would normally be exempt from premarket notification except that the vacuum-powered devices are used in hospitals and other professional health care settings, whereas the Arianna BABY-Vac is intended for home use with a household vacuum cleaner. Thus the device was intended for lay use whereas the commercially distributed devices within this generic type are for health care professional use only. Thus the device required premarket notification. Without premarket notification, the device was rendered adulterated under 21 USC §351(f)(1)(B)and misbranded under 21 USC §352(o).

 

In 2008 A Warning Letter was sent to Pneumex, Incorporated regarding their products including Pneu-MAP and Pneu-Back Chairs. The Pneu-MAP device was a Class I medical device under 21 CFR 890.1600 exempt from premarket notification subject to the limitations in 21 CFR 890.9. The Pneu-MAP device is an intermittent pressure measurement system and is identified in the regulation as a generic type of device for intended to measure the actual pressure between the body surface and the supporting media. The manufacturer had labeled the device as intended for the diagnosis of scoliosis. The labeling of the device for an intended use different from the intended use of a legally marketed device made the device subject to premarket notification. Likewise, the Pneu-Back Chair was identified as an isokinetic testing and evaluation system under 21 CFR 890.1925 exempt from premarket notification subject to the limitations in 21 CFR 890.9. The regulation identified such a device as a rehabilitative exercise device intended to measure, evaluate, and increase the strength of muscles and the range of motion of joints. The manufacturer had labeled the device for the treatment of scoliosis. The labeling of the Pneu-Back Chair for an intended use different from the intended use of a legally marketed device made the device subject to premarket notification. These violations of premarket notification, in addition to other regulatory violations, rendered the products adulterated and misbranded.(4)

 

In a 2010 Warning Letter sent to Aqueduct Medical, Inc., manufacturers of AqueCool Rapid Recovery System, AqueVest device and AqueCool Masque devices classified as water circulating hot or cold packs under 21 CFR 890.5720. These devices are Class II medical devices exempt from premarket notification within the limitations of 21 CFR 890.9. These devices are intended for medical purposes to provide hot or cold therapy for body surfaces. The company was found to be marketing the devices with claims for rapid recovery and/or accelerated healing, exceeding the limitations of 21 CFR 890.9, thus requiring premarket notification. Because the company had not provided premarket notification, the devices were found to be adulterated under 21 USC §351(f)(1)(B) and misbranded under 21 USC §352(o).(5)

 

In a 2011 Warning Letter to Non-Invasive Monitoring Systems, Inc., FDA cited an Exer-Rest device as being violative. The Exer-Rest is a therapeutic vibrator, a Class I exempt device when intended for relaxing muscles and relieving minor aches and pains under 21 CFR 890.5975. The manufacturer had marketed the device for uses exceeding the intended uses in the classification regulation, namely that the company had promoted the device as being intended for use during CPR as “cardioprotective preconditioning,” for brain damage reduction in ischemic strokes, for asphyxia, for enhancing brachial endothelial function, for cardiovascular disease, for asthma and for fibromyalgia. The marketing of the Exer-Rest for an intended use different from the intended use of a legally marketing device made the device subject to premarket notification. Failure to provide premarket notification rendered the device adulterated and misbranded.(6)

 

Another instance of exceeding the limitations of 21 CFR 890.9(a) that rendered a device adulterated and misbranded is in a 2011 Warning Letter to Medicepts, Inc.(7) The company sold a Spine Six Biomotion Spinal System that was a Class I medical device under 21 CFR 890.5380 exempt from premarket notification subject to the limitations in 21 CFR 890.9. Devices under 21 CFR 890.5380 are powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. The company had marketed the devices with claims for cervical and lumbar pain, herniated discs, disc bulges, radiculopathy, disc protrusions and the like, exceeding the limitations of 21 CFR 890.9(a). The marketing of the Spine Six Biomotion Spinal System for an intended use different from the intended use of a legally marketing device made the device subject to premarket notification. Failure to provide premarket notification rendered the device adulterated and misbranded.

FDA enforcement action based on marketing devices using claims beyond the limitations of 21 CFR 890.9(a) without premarket notification have occurred. Keep the limitations of 890.9(a) in mind, especially in marketing. Overreaching with your claims can have consequences.

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(1) Intermittent Pressure Measure System

(a) Identification. An intermittent pressure measurement system is an evaluation device intended for medical purposes, such as to measure the actual pressure between the body surface and the supporting media.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9

 

(2)21 CFR 890.9 in full:

The exemption from the requirements of premarket notification (section 520(k) of the Act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) the device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g. a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identified infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

c)The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate market for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in 812.3(k) of this chapter; and

(9) For near patient testing (point of care).

 

(3) Warning Letter to IFC International, CHI-12-05, September 15, 2005, available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/ucm075561.htm

 

(4) Warning Letter to Pneumex, Incorporated SEA 09-07, December 5, 2008, available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048053.htm

 

(5) Warning Letter to Aqueduct Medical, Inc., December 22, 2010, available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm238277.htm

 

(6) Warning Letter to Non-Invasive Monitoring Systems, Inc., EC100318, March 18, 2011, available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm247798.htm

 

(7) Warning Letter FLA-11-13, Medicepts, Inc. January 25, 2011, available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm242439.htm