News
January 21, 2015

FDA Releases New Guidance Proposing Further Limitations on Regulatory Oversight of Low Risk Medical Devices

Arnold & Porter Advisory

Last week, the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) issued draft guidance entitled "General Wellness: Policy for Low Risk Devices,"1 announcing plans to deregulate certain low risk devices intended to help maintain a general state of health or associate healthy lifestyles with reducing the risk or impact of certain chronic diseases or conditions.  Stakeholders may submit comments on the draft guidance until April 20, 2015.2

Under the guidance, CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA), and if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FDCA and implementing regulations.3 In other words, CDRH does not intend to actively regulate products that meet the definitions in the guidance, regardless of whether the product would otherwise meet the definition of a device under section 201(h) of the FDCA. 

This document is another example of CDRH examining the products within its jurisdiction and making a risk-based, resource-saving decision to focus its oversight activities on the medical devices in most need of regulatory oversight.  In the last three years, CDRH has issued five other policy or guidance documents that either limit or propose to limit oversight of various devices, including Medical Device Data Systems (MDDS)4 and certain medical image archiving and communications software.5

Recent CDRH Policy Documents limiting FDA's active oversight of Certain Medical Devices

  • Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices final guidance (December 2011) - CDRH communicates its intent to exercise enforcement discretion with regard to the premarket notification requirements of the FDCA for certain in vitro diagnostic and radiology devices.6
  • Mobile Medical Applications final guidance (September 2013 ) - CDRH clarifies that it does not intend to actively regulate a subset of mobile apps that meet the regulatory definition of a "device" but pose minimal risk to patients and consumers.7
  • FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework (April 2014) - FDA suggests that Health IT products that meet the definition of a medical device but provide only administrative health IT functionality or health management health IT functionality do not warrant regulatory oversight by FDA.8
  • Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices draft guidance (June 2014) - CDRH indicates that it does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices, and medical image communications devices.9
  • Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements draft guidance (August 2014) - CDRH indicates that it intends to exempt over 100 Class I and Class II medical devices from the premarket notification requirements of the FDCA.10

 

CDRH defined "general wellness products" as products that: "(1) are intended for only general wellness use, as defined in this guidance, and (2) present a very low risk to users' safety."  CDRH explained that general wellness products may include "exercise equipment, audio recordings, video games, software programs and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded), provided these two criteria are met."  If the product's intended uses are not limited to the above general wellness intended uses, FDA's guidance does not apply.  The guidance includes a useful "Decision Algorithm" for stakeholders to help determine whether their product would be considered a general wellness product.  

Intended for General Wellness

Under the guidance, a general wellness product must have: "(1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition."

The first category of general wellness intended uses involves claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any reference to diseases or conditions.  This first category of general wellness claims relate to: (1) weight management; (2) physical fitness, including products intended for recreational use; (3) relaxation or stress management; (4) mental acuity; (5) self-esteem (e.g., devices with a cosmetic function that make claims related only to self-esteem); (6) sleep management; or (7) sexual function.  FDA's examples of this category of general wellness claims include:

  • Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals;
  • Claims to promote physical fitness, such as to help log, track, or trend exercise activity, measure aerobic fitness, improve physical fitness, develop or improve endurance, strength or coordination, or improve energy;
  • Claims to promote sleep management, such as to track sleep trends; and
  • Claims that address a specific body structure or function, such as to enhance cardiac function or enhance or improve sexual performance.

The second category of general wellness intended uses is comprised of two subcategories: (1) intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and (2) intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions. 

For both subcategories of disease-related general wellness claims, FDA recommended that products only contain references where it is "well understood" that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition.  That is, the claim that the healthy lifestyle choice(s) may play an important role in health outcomes "should be generally accepted" or "such associations are typically described in peer-reviewed scientific publications." Examples of chronic diseases for which a healthy lifestyle is associated with risk reduction or helping patients to live well with a disease include heart disease, high blood pressure, and type 2 diabetes. 

Low Risk 

CDRH's general wellness policy does not extend to devices that present inherent risks to a user's safety.  Whether a device is low risk for purposes of the guidance is determined by whether the product: (1) is invasive (meaning penetrating or piercing the skin or mucous membranes of the body); (2) involves an intervention or technology that may pose a risk to a user's safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants; (3) raises novel questions of usability;11 or (4) raises questions of biocompatibility.  If the answer to any of these questions is "yes," the device is not a low risk general wellness product and is not covered by the guidance.  In assessing whether a device is low risk for purposes of this guidance, FDA recommended that stakeholders consider whether CDRH actively regulates products of the same type as the product in question.

Examples of Low Risk General Wellness Products 

CDRH's guidance included five examples of products that the agency would consider to be low risk general wellness products.  These include: (1) a mobile application that plays music to "soothe and relax" an individual and to "manage[] stress"12; (2) a mobile application that solely monitors and records daily energy expenditure and cardiovascular workout activities to "allow awareness of one's exercise activities to improve or maintain good cardiovascular health";13 (3) a mobile application that monitors and records food consumption to "manage dietary activity for weight management and alert the user, healthcare provider, or family member of unhealthy dietary activity";14 (4) a portable product that claims to monitor the pulse rate of users during exercise and hiking;15 and (5) a product that is intended to mechanically exfoliate the face, hands and feet to make the skin smoother and softer.16

FDA explained that a product's inclusion under the guidance does not establish that it has been shown to be safe, effective, and not misbranded for its intended use.  Further, the guidance does not preclude FDA from consulting with the Consumer Product Safety Commission (CPSC) as to whether a general wellness product is a consumer product under CPSC's authority or a device.17

Conclusion 

CDRH's general wellness guidance offers needed clarity for manufacturers, developers, and related stakeholders.  In particular, the guidance explains that promotional materials and advertising must carefully articulate intended uses and avoid disease or condition-specific claims.  Thus, manufacturers and developers should implement policies, procedures and processes for the creation, review, and approval of promotional or advertising materials (e.g., legal/regulatory review), and consider monitoring relevant websites or promotional claims created by third party vendors or downstream retailers that could be attributed to the company.  Employees should also be trained to understand the types of claims and statements they can make on behalf of the company (e.g., press releases, social media, etc.).

Monitoring promotional and advertising claims is particularly important because CDRH recommended that claims associated with a product be "well understood," "generally accepted," or "described in peer-reviewed scientific publications."  Although additional clarity from CDRH is needed to establish this level of substantiation for making general wellness claims, manufacturers and developers will need to consider whether their products and supporting promotional materials would satisfy the stated criteria to be excluded from medical device requirements.  Manufacturers and developers must also consider claim substantiation and general advertising requirements established by the Federal Trade Commission (FTC) and state consumer protection laws.  Without appropriate substantiation of health-related claims, these products could be subject to FTC or state enforcement or private litigation based on false or misleading claims or deceptive trade practices.  The regulatory risks may increase where the absence of appropriate substantiation increases the risk to users (e.g., novel products, products aimed at vulnerable populations, etc.).

In addition, as mobile applications and wearable devices continue to evolve to include and measure specific personal health information (e.g., drug dosing information or blood glucose levels), manufacturers will need to continue to scrutinize the claims and intended uses of their product to stay within the general wellness guidance.  More importantly, manufacturers and stakeholders will need to remain vigilant about any product enhancements or additions that could change the product's regulatory status or increase the risk to users.  Such enhancements or additions may involve, for example, novel questions of usability and biocompatibility, clinical diagnoses or interactions with other FDA-regulated devices.  Finally, FDA's position with respect to these devices does not necessarily exempt them from other areas of potential legal concern, such as privacy and security of information processed or stored by such products.

  1. Available here.

  2. 80 Fed. Reg. 2712 (Jan. 20, 2015), available here.

  3. These include, but are not limited to: (i) registration, listing and premarket notification requirements (21 C.F.R. Part 807); labeling requirements (21C.F.R. Part 801 and 21 C.F.R. 809.10); good manufacturing practice requirements as set forth in the Quality System regulation (21 C.F.R. Part 820); and Medical Device Reporting (MDR) requirements (21 C.F.R. Part 803).

  4. See76 Fed. Reg. 8637 (Feb. 15, 2011) (the FDA issued a final rule reclassifying MDDS from Class III (subject to premarket approval) to Class I (subject to general controls). The rule, which was codified at 21 C.F.R. 880.6310, resulted in the registration listing of several hundred previously unregulated data transfer and connectivity devices.

  5. In June 2014, FDA issued a Draft Guidance for comment in which it proposed to its exercise enforcement discretion by not requiring MDDS and medical image archiving and communications devices to comply with medical device requirements. See 79 Fed. Reg. 36072 (Jun. 25, 2014),  available here.

  6. Available here.

  7. Available here.

  8. Available here.

  9. Available here.

  10. Available here.

  11. For example, mobile applications intended to supplement approved drug therapies by allowing physicians to remotely monitor patient adherence to a prescribed dosing regimen through smart pill bottles and remotely change dosing schedules based on data reported from body-word biometric monitoring devices.

  12. CDRH explained that the product has no disease or condition claims and has no inherent risk to a user's safety.

  13. CDRH explained that the product refers to "a specific organ only" and not a disease or medical condition, and the risks to the user (e.g., inaccuracy) are low.

  14. CDRH explained that the product refers to diet and weight only and that monitoring or recording food consumption poses a low risk to user safety.

  15. CDRH explained that exercise and hiking does not refer to a disease or medical condition and that the monitoring technology poses a low risk to user safety.

  16. CDRH explained that the product relates to self-esteem and not a specific disease or medical condition, and that the exfoliating technology poses a low risk to user safety as it does not penetrate the stratum corneum.  CDRH clarified that if the product was intended to exfoliate skin to "enhance the delivery of a topically applied product containing one or more active pharmaceutical ingredients," the product would present an inherent risk to user safety because of its "invasive nature," and thus would not be a low risk general wellness product.

  17. FDA may coordinate with other agencies and authorities, such as the CPSC, to determine jurisdiction over products.  If a product is a device under section 201(h) of the FDCA, it is generally excluded from CPSC's authority over "consumer products" under the Consumer Product Safety Act (15 U.S.C. § 2052(a)(5)(ii)(H)). However, under other statutory authorities the CPSC administers, both CPSC and FDA may have jurisdiction over certain products that meet the definition of a medical device when marketed under certain conditions.

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