Life Science Compliance Update

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26 posts from January 2015

January 30, 2015

Connecticut Transparency Law: Manufacturers Must Only Report Payments to APRNs Practicing Independently

CT

Manufacturers must report quarterly on their transfers of value made to advance practice registered nurses (APRNs) practicing in Connecticut. This group includes nurse practitioners, clinical nurse specialists, nurse anesthetists, and nurse midwives. APRNs are excluded from the reporting obligations under the Federal Physician Payments Sunshine Act, but Connecticut passed this disclosure requirement as part of a new law allowing APRNs to practice and prescribe independently of physicians. 

Proposed Bill No. 257 complicates the reporting obligations in Connecticut by requiring that applicable manufacturers only report on transfers of value made to APRNs who are indeed practicing independently. 

AN ACT CONCERNING REPORTING OF PAYMENTS BY MANUFACTURERS TO INDEPENDENTLY-PRACTICING ADVANCED PRACTICE REGISTERED NURSES.

Be it enacted by the Senate and House of Representatives in General Assembly convened:

That section 21a-70f of the general statutes be amended to require an applicable manufacturer of a covered drug, device, biological or medical supply to report only those payments or other transfers of value made to an advanced practice registered nurse who practices independently.

Statement of Purpose:

To clarify that section 21a-70f of the general statutes requires manufacturers to report only information on advanced practice registered nurses in independent practice.

Public Act No. 14-12 first provided APRNs with independence last year. It stated that an advanced practice registered nurse having…maintained [his/her] license for a period of not less than three years, and…engaged in the performance of advanced practice level nursing activities in collaboration with a physician for a period of not less than three years…may, thereafter, alone or in collaboration with a physician or another health care provider licensed to practice in this state perform diagnoses, and prescribe, dispense and administer medical therapeutics and corrective measures and dispense drugs in the form of professional samples.

The language of the Act also included a Sunshine provision for APRNs, but did not specify whether this was for all nurse practioners or only those that had worked for longer than three years and were working independently:

Not later than July 1, 2015, and quarterly thereafter, an applicable manufacturer that provides a payment or other transfer of value to an advanced practice registered nurse, who is practicing in the state, shall submit to the Commissioner of Consumer Protection, in the form and manner prescribed by the commissioner, the information described in 42 USC 1320a-7h, as amended from time to time.

Proposed Bill 257 makes it clear that manufacturers must keep track of which APRNs have made the decision to work independently and have the ability to prescribe, and only track those payments. 

In looking at the Connecticut Department of Public Health website, it's possible that manufacturers will have a list upon which to reference in making their disclosure reports. APRNs must file a Notification of Intent to Practice Independently with the Department. The form states: 

By completing this form I am providing written notice to the Department of my intention to practice independently and have in my possession the documentation described above. Documentation may include a dated letter from the Connecticut physican(s) that I collaborated with for a period of not less than three (3) years and for not less than 2,000 hours.

Perhaps Connecticut will publish the confirmed list of independent APRNs for manufacturers to reference. 

Thanks to Nico Fiorentino, JD, Sr. Advisor, Research & Compliance, G&M Health, LLC for the tip. 

 

January 29, 2015

FDA Device Guidance: General Wellness: Policy for Low Risk Devices

  Mobile Apps

The Food and Drug Administration set an ambitious guidance schedule for itself this year. On January 20, the Center for Devices and Radiological Health (CDRH) published two guidances—one on medical device accessories and the other on low risk or “general wellness” devices. This article walks through the general wellness guidance, in which FDA provides many examples of devices they consider to be low risk general wellness products. The guidance, which spends a lot of time on general health and fitness mobile apps, makes clear FDA does not intend to regulate such products.

Products classified as “medical devices” either need to be approved by FDA through pre-market approval or show that they are substantially equivalent to an existing device. Both processes take time and resources, so avoiding the designation is in a company’s best interest. Thus, FDA’s guidance on whether a product is a “general wellness product” instead of a medical device is a very useful document.

FDA states that a general wellness product has:

(1)  An intended use that relates to a 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. Such claims can relate to diet, fitness, or improving concentration for example, but must not focus on specific diseases. 

General Wellness Claim

Not a General Wellness Claim

Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals

A claim that a product will treat or diagnose obesity

A claim that a product will treat an eating disorder, such as anorexia

Claims to promote relaxation or manage stress without reference to anxiety disorders or other reference to a disease or condition

Claims to increase, improve, or enhance the flow of qi

A claim that a product helps treat anxiety

 

Claims to improve mental acuity, instruction following, concentration, problem solving, multitasking, resource management, decision-making, logic, pattern recognition or eye-hand coordination

A claim that a computer game will diagnose or treat autism

 

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

A claim to restore a structure or function impaired due to a disease, e.g., a claim that a prosthetic device enables amputees to play basketball

 

A claim that a product will treat muscle atrophy or erectile dysfunction

Claims to promote sleep management, such as to track sleep trends

Claims to promote self-esteem, such as to boost self-esteem

The second category of general wellness claims allows for mention of particular diseases where a product is intended to help achieve a healthy lifestyle. For example, a product that helps track fitness goals may be promoted as helping to reduce the risk of heart disease. FDA states that these claims should only reference a disease where it is well understood in the medical community that healthy lifestyle choices may reduce the risk or impact of a medical condition. Examples of chronic diseases for which a healthy lifestyle is associated with risk reduction or help in living well with that disease include heart disease, high blood pressure, and type 2 diabetes.

Even certain claims that meet the "general wellness" standards described above will not extend to devices that present inherent risks to a user’s safety. The following attributes of a product present inherent risks, according to FDA:

  • Invasive products, such as implants promoted for improved self-image
  • Products that involve 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--examples include sunlamp products.
  • Raises novel questions of usability; or
  • Raises questions of biocompatibility. 

FDA notes that while certain products, such as laser technology for skin rejuvenation may indeed improve confidence (a general wellness claim), the inherent risks keep the products under FDA oversight. 

FDA's Examples of Low Risk General Wellness Products

(1) A mobile application plays music to “soothe and relax” an individual
and to “manage stress," where claims relate only to stress management, not to medical conditions. 

(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." FDA makes an important statement here: "To the extent the monitoring or recording exercise activities present risks (such as inaccuracy), when made in the absence of disease or medical condition claims, the risks to the user’s safety are low. Therefore, this product meets both criteria for a low risk general wellness product."

(3)  A mobile application 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”.

(4)  A portable product that claims to monitor the pulse rate of users during exercise and hiking.

(5)  A product is intended to mechanically exfoliate the face, hands and feet to make the skin smoother and softer.

FDA explains that this claim relates to self-esteem and does not refer to a specific disease or medical condition, and thus is a general wellness claim. The technology for exfoliating the face poses a low risk to the user’s safety as it does not penetrate the stratum corneum, notes FDA. If, however, "the product exfoliates the skin to enhance the delivery of a topically applied product containing one or more active pharmaceutical ingredients through the stratum corneum, the product would present inherent risks to the user’s safety because of its invasive nature." 

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So far, the low-risk general wellness guidance has been looked upon favorably by the medical device industry as providing some clear examples of products that are outside of FDA's regulatory scope. Especially as more health and fitness related apps come to market, it is good to know that the mere mention of a disease in promotional materials does give FDA automatic authority to regulate it. 

Comments regarding this draft are due by April 20, 2015. View General Wellness: Policy for Low Risk Devices here. 

 View our article on FDA's medical device accessory guidance here

FDA Device Guidance: Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types

Accessory

The Food and Drug Administration set an ambitious guidance schedule for itself this year. On January 20, the Center for Devices and Radiological Health (CDRH) published two guidances—one on medical device accessories and the other on low risk or “general wellness” devices. This article walks through the accessory guidance, in which FDA clarifies that medical device accessories will not automatically take on the classification (Class I, II, or III) of the “parent device.” The agency will regulate based on the risks that individual accessories present when used with their parent device, and not based on the risks of the parent device.

As a background, in the U.S., medical devices are divided into three categories.

  • Class 1 (low risk): includes, for example, examination gloves, elastic bandages, tongue depressors, hand-held surgical instruments. Most do not require FDA approval, but manufacturers must register the device and company on FDA’s website. The length of the approval process tends to be less than one month.
  • Class 2 (medium risk): includes products that could harm a patient if they malfunction or are used improperly. Nearly all must go through a 510(k) pre-market notification submission where new products must be compared to an already cleared predicate device. FDA reviews 510(k) applications within 90 days, but also may drag on up to a year.
  • Class 3 (high risk): includes products that could seriously injure or kill a patient if they malfunction or are used improperly. These devices must go through a rigorous pre-market approval (PMA) process that requires clinical trials and may take up to three years to obtain FDA approval.

What are medical device accessories, and in what Class do they belong?

In its guidance, FDA states that an accessory device is one that is intended for use with one or more “parent devices,” or that is intended to support, supplement, and/or augment the performance of one or more parent devices. FDA states that they will determine whether an article is intended for use with a parent device by the "labeling and promotional materials for the potential accessory device (rather than by the labeling and promotional materials for the parent device)."

For example, a parent device might be an automated external defibrillator. A rechargeable battery would be considered an accessory that supports the defibrillator’s intended use. FDA also states that a device can supplement the performance of a parent device as in the case of a pulse oximeter supplementing a multi-parameter monitor to display oxygen saturation. The pulse oximeter does not change its parent device’s intended use, which FDA states is to record and display multiple physiological parameters. A device may also augment a parent’s performance by enabling the device to perform its intended use more safely or effectively. For example, “a guidewire augments the performance of a bone-cutting instrument by increasing precision of the parent device and reducing the risk to the patient.”

FDA clarifies that these device accessories would not automatically take on the classification of their parent devices. "For example,” notes the agency, “if a parent device warrants regulation as a Class II device but an accessory to the parent device presents lower risks, we would regulate the accessory as a Class I rather than a Class II device.”

"FDA intends to determine the risk of accessories and the controls necessary to provide a reasonable assurance of their safety and effectiveness according to their intended use in the same manner that is used to determine such for devices that are not accessories," FDA states. "Because accessories are intended to be used with and to support, supplement, and/or augment one or more parent devices, FDA will determine the risks of accessories when used, as intended, with the parent device type" (emphasis added). 

The agency clarifies that determining the risks of accessories according to their use with parent devices does not mean that all risks of a parent device are imputed to the accessory--the risk profile of an accessory can "differ significantly" from that of the parent device, warranting differences in regulatory classification. "In determining the classification of an accessory, FDA will evaluate the risks imposed by the accessory’s impact on the parent device and any unique risks of the accessory independent of its parent device," states FDA. "As with the classification of any other device, the types of regulatory controls necessary to control the risks will determine the regulatory class for accessories."

FDA offered an important clarifications regarding computers and iPhones: 

It is important to note that articles that do not meet the definition of an accessory will not be treated as accessories simply because they may be used in
conjunction with a device. For example, a mobile phone that is used as a
general platform for applications that include mobile medical applications that
are medical devices, or an off-the-shelf computer monitor used to display
medical data would not be considered accessories unless they are intended for
use with such devices.

FDA's guidance also stressed that companies should pursue a de novo classification pathway for many device accessories. This process provides a pathway to Class I or Class II classification for accessories for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there are no legally marketed predicate device.

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Click here to view Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types. Comments are due by April 20. 

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