New FDA Guidance on Low Risk and

General Wellness Products

April 8, 2015

Sheva Sanders [sheva.sanders@stinsonleonard.com / 612.335.1588]

Ryan McGary [ryan.mcgary@stinsonleonard.com / 612.335.7064]

HYATT Regency, Minneapolis, Minnesota

• The views expressed here are solely those of the

presenters and do not necessarily reflect the views

of our firm or any of our clients.

• These slides support a verbal briefing and should not

be relied upon to support any conclusion of law or

fact.

• These slides—and the verbal briefing they support—

are intended for educational purposes and should

not be construed as legal advice.

NEW FDA GUIDANCE

• Four recent FDA guidances dealing with consumer

technology:

▫ “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices”

Final Guidance – Issued 2/2015

http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm401996.pdf

▫ “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types”

Draft Guidance – Issued 1/2015

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429672.pdf

NEW FDA GUIDANCE

• Four recent FDA guidances dealing with consumer

technology (continued):

▫ “Mobile Medical Applications”

Final Guidance – 2/2015 (supersedes 9/2013 guidance)

http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf

▫ “General Wellness: Policy for Low Risk Devices”

Draft Guidance – 1/2015

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf

WHAT IS A “MEDICAL DEVICE”?

• Medical devices are regulated under the Federal

Food, Drug, and Cosmetic Act (“FDCA”)

• Section 201(h) of the FDCA defines a medical

device as a device:

“. . .which is [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease . . . [or] intended to affect the structure or any function of the body of man or other animals.”

WHAT IS “INTENDED USE”?

• Thus, to be a medical device, a product needs to

be “intended” for a medical purpose:

▫ Diagnosis

▫ Treatment

▫ Affecting the structure or function of the body

• Major determinant of “device” status is the

manufacturer’s intent with regard to how the

consumer should use the product. That controls

how the product is regulated, not how the

consumer actually does use the product.

• Manufacturer’s claims for a product establish the

“intended use” which means . . .

WHAT IS “INTENDED USE”?

• The same product could be a device or not a

device depending upon the manufacturer’s claims.

• For example –

▫ Exercise equipment intended for maintaining goodhealth is not a device, while the same equipment with claims for cardiac rehabilitation of heart surgery patients would be a device.

▫ A device for the ear that is claimed to be a sound amplifier to enhance a hunter’s normal hearing to better hear prey would not be a device, while a hearing aid claimed to help the hearing impaired would be a device.

• Words – both written and spoken.

▫ Labeling and promotional materials.

MEDICAL DEVICE CLASSIFICATION

• FDA’s risk-based regulatory framework for device

classification

Class Risk Regulatory Requirements

Class I Low Typically, mostly observance of the quality system

and reporting of adverse events.

Class II Medium Class I requirements plus often an obligation to

seek FDA clearance before marketing. FDA

clearance involves showing the product is

substantially equivalent to others in the market,

and often involves 90 or more days of FDA review.

Class III High Class I requirements plus an obligation to seek

FDA approval before marketing. Approval, in

contrast to clearance, involves showing

fundamentally that the product is safe and

effective. Often, this involves clinical studies and

takes much longer in terms of FDA review.

WHAT IS “ENFORCEMENT DISCRETION”?

• By "exercise enforcement discretion" FDA means

that it does not intend to enforce requirements—

that otherwise apply—under the FDCA.

• Namely, requirements that products be regulated

and approved by FDA.

▫ Premarket (e.g., establishment registration, listing, premarket review)

▫ Postmarket (e.g., adverse events, postmarket surveillance, Quality System Regulations, performance standards, restrictions on sale)

PRODUCT EXAMPLES

APPLE WATCH

• In December 2013 meeting, FDA said it would not need to

regulate glucose meter that monitored blood sugar as this

was intended to allow user to better understand their

nutrition.

• However, FDA stated they would

step in if this feature were marketed

directly to diabetics.

• Apple dropped plans to monitor blood pressure and oxygen

levels in blood due to inconsistent performance results. Future

versions of the Apple Watch may have these features. If

Apple interpreted these numbers so as to provide health-

related advice, they may need FDA approval.

PROTEUS DIGITAL HEALTH – HELIUS

• Microchip attached to pill contains technology

which communicates time-stamp to a wearable

monitor; monitor receives, stores, and wirelessly

sends ingestion confirmation data to software;

software organizes and displays ingestion events.

• FDA approved this device after de novo evaluation

in 2012.

• Approved for time-stamped, patient-logged events

as well as recording heart rate, activity levels, etc.

HANDYSCOPE

• Attachment that converts a smartphone into a

dermatoscope. Slides onto phone and magnifies

the camera up to 20x. Concurrent app displays

picture and allows for secure data storage.

• FDA cleared as Class I device.

DIGIPILL

• Smartphone app. uses “hypnotic audio pills” to help

you relax, preserve, become motivated, move on,

clear your mind, and even make you more

“irresistible,” etc.

• Product not FDA regulated.

ALIVECOR ECG MONITOR

• Device attached to smartphone records ECG

rhythms. These recordings are displayed and stored

on the smartphone.

• FDA cleared as a Class II device in 2014.

MOBISANTE ULTRASOUND

• Ultrasound Imaging System that attaches to

smartphone for display of ultrasound image.

• FDA cleared as Class II device in 2010.

MDDS GUIDANCE

• Applies to:

▫ Medical Device Data Systems (“MDDS”)

21 CFR 880.6310 – See next slide

▫ Medical Image Storage Devices (“MISDs”)

21 CFR 892.2010 – Provides electronic storage and

retrieval functions for medical images

▫ Medical Image Communications Devices (“MICDs”)

21 CFR 892.2020 – Provides electronic transfer of

medical image data between medical devices

MDDS GUIDANCE

• MDDS – Down-classified in 2/2011 from Class III to I

• Devices intended to transfer, store, convert from

one format to another according to preset

specifications, or display medical device data.

▫ Hardware or software

• E.g., software that:

▫ Collects output data from ventilator,

▫ Stores historical blood pressure information,

▫ Converts digital data generated by a pulse oximeter into a

printable format, or

▫ Displays a previous electrocardiogram for a particular patient

MDDS GUIDANCE

• MDDS does not include products that:

▫ Are intended for active patient monitoring

Clinical context requires a timely response

Clinical condition (disease or diagnosis) requires a timely response

▫ Modify the medical device data

▫ Control or alter the functions or parameters of any connected medical devices

MDDS GUIDANCE

• FDA “does not intend to enforce compliance with

the regulatory controls that apply to MDDS, MISDs,

and MICDs due to the low risk they post to patients

and the importance they play in advancing digital

health.”

• Enforcement Discretion – FDA explains its position

effectively “exempts” marketers from:

▫ Registration and listing,

▫ Premarket review,

▫ Postmarket reporting, and

▫ Quality System Regulation.

ACCESSORIES DRAFT GUIDANCE

• What is an accessory?

▫ A device that is intended to support, supplement,

and/or augment the performance of a parent

device.

▫ Based on labeling and promotional materials for the

potential accessory.

• What is a parent device?

▫ A finished device whose performance is supported,

supplemented, and/or augmented by one or more

accessories.

• Example: Infusion pump stand (accessory) supports intended use of an infusion pump (parent).

ACCESSORIES DRAFT GUIDANCE

• Traditional approach – Accessories generally

classified by inclusion in parent’s classification or

issuance of a unique classification.

• Proposed approach adds latitude:

▫ FDA intends to evaluate accessories in the same

manner as non-accessory devices.

▫ FDA will not impute to the accessory all risks of a parent

device.

▫ FDA will evaluate risks imposed by accessory’s impact

on parent device and any unique risks of the accessory

independent of the parent device.

▫ The regulatory controls necessary to control the risks will

determine the accessory’s regulatory class.

ACCESSORIES DRAFT GUIDANCE

• Accessory classification through de novo process

▫ FDA encourages use of the de novo classification

process to request a risk-based classification of

accessories that have not been previously

classified or approved in an application for a PMA.

▫ Pathway to Class I or II classification for low- to moderate-risk medical devices that are novel and

not substantially equivalent to any legally

marketed device.

ACCESSORIES DRAFT GUIDANCE

• Dexcom Share Direct Secondary Displays System

▫ MMA that allows people with diabetes to

automatically and securely share data from a

continuous glucose monitor with “followers”

(caregivers) in real-time using a mobile device.

▫ Classified through the de novo process as a Class II, 510(k)-exempt device (1/2015).

▫ Accessory to Dexcom CGM System – a Class III

device.

• Represents departure from traditional policy for

accessories.

MMA GUIDANCE

• Three categories of mobile apps:

▫ Category 1: mobile apps / not “medical devices”

Are not considered “medical devices” and thus outside of FDA control.

▫ Category 2: mobile apps / enforcement discretion

Are (or may be) “medical devices”, but present a low risk to patients.

▫ Category 3: “mobile medical apps”

Are medical devices and present enough risk that the FDA will exercise its regulatory control.

MMA GUIDANCE

• Category 3: “Mobile Medical App” Defined

▫ A mobile app that meets the FDCA definition of “medical device” and is intended either:

to be used as an accessory to a regulated

medical device; or

to transform a mobile platform into a regulated medical device.

▫ Subset of of mobile apps that are the focus of FDA regulatory oversight.

MMA GUIDANCE

Category 3: MMAs – 3 Types

• Apps that function as an extension of an existing medical

device by connecting to it (either via wired or wireless

links) for purposes of controlling the device or for use in

active patient monitoring or analyzing medical device

data.

▫ E.g., App that controls insulin on insulin pump

• Apps that transform the mobile platform into a regulated

medical device by using attachments, display screens, or

sensors or by including functionalities similar to those of

currently regulated medical devices.

▫ E.g., Attachment of a blood glucose strip reader to a

mobile platform to function as a glucose meter

MMA GUIDANCE

Category 3: MMAs – 3 Types

• Apps that become a regulated medical device

(software) by performing patient-specific analysis

and providing patient-specific diagnosis, or

treatment recommendations.

▫ E.g., Apps that use patient-specific parameters and calculate dosage or create a dosage plan for

radiation therapy.

Mobile Apps – Not Considered MMA

Category 1: Mobile Apps – Not Medical Devices

Category 2:Mobile Apps – Enforcement Discretion

• Library of clinical descriptions

• Medical flash cards

• Certification or recertification preparation apps

• Games to train health professional in advanced CPR skills

• Allow users to input pill shape, color or imprint and displays pictures and names of pills that match this description

• Find the closest medical facilities

• Help guide patients to ask appropriate questions to their physician

• Track, review and pay medical bills online

• Manage or schedule hospital rooms or bed space

• Help patients (i.e., users) self-manage their disease or conditions without providing specific treatmentsuggestions

• Provide patients with simple tools to organize and track their healthinformation

• Provide easy access to informationrelated to patients’ health conditions or treatments

• Help patients document, show or communicate potential medicalconditions to health care providers

• Automate simple tasks for health care providers

• Enable patients or provisions to interact with Personal Health Record(PHR) or Electronic Health Record(EHR) systems

KEEPING UP WITH MMAs

• MMA Guidance offers more examples

• FDA mobile apps website

▫ http://www.fda.gov/MedicalDevices/Productsa

ndMedicalProcedures/ConnectedHealth/Mobile

MedicalApplications/default.htm

• FDA intends to list example types that it intends to:

▫ Consider as not a device;

▫ Exercise enforcement discretion over; or

▫ Regulate.

GENERAL WELLNESS DRAFT GUIDANCE

• FDA does not intend to examine low risk

general wellness products to determine

whether they are devices or, if they are

devices, whether they comply with FDA

regulatory controls.

• Types of products eligible – two-part inquiry:

▫ Intended only for “general wellness use” and

▫ Present a very low risk to users’ safety.

GENERAL WELLNESS DRAFT GUIDANCE

• What falls in the category of “general wellness?”

▫ First Category: Intended use claim must relate to

maintaining or encouraging general state of health

without any reference to diseases or conditions.

Included: intended uses such as weight

management, physical fitness, relaxation or stress

management, etc.

Not included: Intended uses such as treating or

diagnosing obesity, treating an eating disorder,

helping the treatment of anxiety, etc.

GENERAL WELLNESS DRAFT GUIDANCE

General Wellness Claims Not a General Wellness Claim

• Claims to promote or maintain a healthy weight or encourage healthy eating

• 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

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

• Claims to promote physical fitness (e.g., help log, track, or trend exercise activity)

• Claims to promote sleep management

• A claim that a product will treat or diagnose obesity

• A claim that a product will treat an eating disorder (e.g., anorexia)

• A claim that a product helps treatanxiety

• A claim that a computer game will diagnose or treat autism

• 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 treatmuscle atrophy or erectile dysfunction

GENERAL WELLNESS DRAFT GUIDANCE

• What falls in the category of “general wellness?”

▫ Second Category: Intended use claim that associates role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions where it is well understoodand accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

Claims of helping to “reduce the risk” of or “living well with” certain chronic diseases.

Generally accepted = “typically described in peer-reviewed scientific publications.”

GENERAL WELLNESS DRAFT GUIDANCE

▫ Examples of disease-related general wellness claims:

Product X promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure.

Software Product Y tracks your caloric intake and helps you manage a healthy eating plan to maintain a healthy weight and balanced diet. Healthy weight and balanced diet may help living well with high blood pressure and type 2 diabetes.

Product Z tracks activity sleep patterns and promotes healthy sleep habits, which, as part of a healthy lifestyle, may help reduce the risk for developing type 2 diabetes.

GENERAL WELLNESS DRAFT GUIDANCE

• What falls outside the category of “low risk?”

▫ The product is invasive.

▫ The product involves intervention or technology

that poses a risk to user’s safety if device controls

are not applied (e.g., lasers, implants, radiation).

▫ The product raises novel questions of usability.

▫ The product raises questions of biocompatibility.

KEY TAKEAWAYS