Games, Medical Devices and the FDA: Now, Near, and Next

1. Games, Medical Devices and the FDA:
Now, Near & Next
June 14, 2012
James M. Flaherty, Jr.
Foley Hoag LLP
jflaherty@foleyhoag
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2. Q: Which video games are
subject to regulation by
the U.S. Food and Drug
Administration (FDA)?
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3. Q: Which video games are
subject to regulation by the
U.S. Food and Drug
Administration (FDA)?
A: All of them! (Potentially)
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4. FDA Mission
 FDA is responsible for protecting the public health by assuring the
safety, efficacy and security of human and veterinary drugs, biological
products, medical devices, our nation’s food supply, cosmetics, and
products that emit radiation.
 FDA is also responsible for advancing the public health by helping
to speed innovations that make medicines more effective, safer, and
more affordable and by helping the public get the accurate, science-
based information they need to use medicines and foods to maintain
and improve their health.
 FDA also has responsibility for regulating the manufacturing,
marketing and distribution of tobacco products to protect the public
health and to reduce tobacco use by minors.
 Finally, FDA plays a significant role in the Nation’s counterterrorism
capability. FDA fulfills this responsibility by ensuring the security of the
food supply and by fostering development of medical products to
respond to deliberate and naturally emerging public health threats.
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5. What Does FDA Regulate?
 FDA regulates products, not the practice of medicine
–Drugs
–Biologics
–Medical devices
–Combination products
–Foods
–Tobacco
–Cosmetics
–Veterinary products
–Radiation-emitting electronic products
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6. How Is FDA Organized?
 FDA is an agency within HHS
 Five Offices and Six Product Centers
– Office of the Commissioner (Margaret Hamburg, MD)
– Office of Medical Products and Tobacco
• Center for Drug Evaluation and Research (CDER)
• Center for Biologics Evaluation and Research (CBER)
• Center for Devices and Radiological Health (CDRH)
• Center for Tobacco Products (CTP)
– Office of Foods
• Center for Food Safety and Applied Nutrition (CFSAN)
• Center for Veterinary Medicine (CVN)
– Office of Global Regulatory Operations and Policy
– Office of Operations
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7. How Is FDA Organized? (cont.)
 FDA is an agency within HHS
 Five Offices and Six Product Centers
– Office of the Commissioner (Margaret Hamburg, MD)
– Office of Medical Products and Tobacco
• Center for Drug Evaluation and Research (CDER)
• Center for Biologics Evaluation and Research (CBER)
• Center for Devices and Radiological Health (CDRH)
• Office of Device Evaluation (ODE)
• Center for Tobacco Products (CTP)
– Office of Foods
• Center for Food Safety and Applied Nutrition (CFSAN)
• Center for Veterinary Medicine (CVN)
– Office of Global Regulatory Operations and Policy
– Office of Operations
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8. How Is FDA Organized? (cont.)
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9. How Is FDA Organized? (cont.)
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10. FDA Legal Authority
 Law. Congress provided FDA with the authority to ensure the safety and
effectiveness of regulated products in interstate commerce.
– Federal Food, Drug & Cosmetic Act (FDCA)
– Public Health Service Act (PHSA)
– Other associated laws, such as the Nutrition Labeling & Education Act and the
Dietary Supplement Health & Education Act
 Regulation. FDA implements the law through “notice and comment
rulemaking” to provide opportunity for public input.
– Regulations codified in Title 21 of the Code of Federal Regulations
 Sub-Regulation. FDA publishes informal documents indicating the
agency’s view on certain topic areas.
– Guidance documents
– Standard operating procedures
 Compliance. FDA ensures compliance with laws and regulations through
inspections, warning letters, civil monetary penalties, and other
enforcement actions.
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11. What Is A Medical Device?
 “The term ‘device’ … means an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent,
or other similar or related article, including any component,
part, or accessory, which is -- (1) recognized in the official
National Formulary, or the United States Pharmacopeia, or
any supplement to them, (2) intended for use in the
diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man
or other animals, or (3) intended to affect the structure or
any function of the body of man or other animals, and which
does not achieve its primary intended purposes through
chemical action within or on the body of man or other
animals and which is not dependent upon being metabolized
for the achievement of its primary intended purposes.”
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12. How Are Medical Devices Classified?
 History of medical device regulation
–Medical Device Amendments of 1976 (FDCA)
 Risk-based classification scheme
–Class I = Lowest risk devices
• Typically no premarket review required
–Class II = Moderate risk devices
• Premarket notification – 510(k)
–Class III = High risk and “novel” devices
• Premarket approval – PMA
–De novo classification process and pending legislation
 Importance of intended use and labeling
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13. IDEs, PMAs, 510(k)s, Oh My!
 Clinical Trials – Investigational Device Exemption (IDE)
– Significant Risk (SR) v. Non-Significant Risk (NSR) Studies
 Premarket Review – Premarket Approval (PMA)
– Generally Class III devices
– Must establish safety and effectiveness (approval)
– Clinical trial data typically required
 Premarket Review – Premarket Notification (510(k))
– Generally Class II devices
– Reasonable assurance of safety and effectiveness (clearance)
– Standard is substantial equivalence to predicate device
 No Premarket Review – General Controls
– Generally no premarket review required for Class I products
• Majority of Class I devices have been exempted from 510(k)
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14. Labeling and Promotion
 Labeling is the link between premarket and postmarket
– Final approved labeling controls scope of postmarket activities
 Intended use of critical importance
 FDA interprets labeling very broadly
– Actual labels
– Package insert
– Written marketing materials
– Websites
– Oral communications
 Advertising and promotion
 Off-label use and promotion
– Adulteration and Misbranding
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15. Current FDA Regulation of Games
 Lots of unknowns
 No approved/cleared games with medical claims
 Classification will be a necessary first step
 FDA’s “Accessory Rule” could be a hurdle for
some games
–Medical device accessories classified and regulated in
same manner as parent devices
 FDA regulation of mHealth devices and mobile
medical apps could provide a template for games
–But this is still evolving
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16. mHealth and Mobile Medical Apps
 July 21, 2011 FDA Draft Guidance Document on Mobile
Medical Applications
– Guidance for all type of apps with medical purpose(s)
– Questions applicability of “accessory rule” to mobile medical apps
– Could apply to some games
 Pending FDA legislation
– Fear of over-regulation
– Both Senate and House bills require FDA to submit a report to
Congress on regulation of health information technology and
mobile medical apps
– Senate bill would permit FDA to issue final guidance on mobile
medical apps only after report to Congress and convening
working group of stakeholders
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17. Possible FDA-Regulated Games
 Brain Plasticity: treatment for schizophrenia to improve
deficits in attention and memory
 Akili Interactive: treatment for cognitive and behavior
disorders like ADHD and depression
 Berkeley study for treatment of amblyopia (lazy eye)
 Games connected to medical devices such as glucose
meters
 Games that use a spirometer for kids with asthma, or
cystic fibrosis
 Games that make medical recommendations (take an
aspirin) or provide medical guidance and advice
 Training systems for surgeons or other physicians
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18. What’s Next?
 Collaboration between FDA and stakeholders
–Early meetings between FDA and industry
–Public meetings
–Citizen petitions
 Guidance document development
–Notice and comment
 Classification
 Clinical requirements and outcomes
–How to show effectiveness?
–Cognitive testing? Brain imaging?
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19. Thank You!
James M. Flaherty, Jr., an attorney with Foley Hoag LLP in Boston,
advises medical device, pharmaceutical, and biotechnology
companies on federal legislative and regulatory issues relating to FDA
law and regulation. His practice also involves representing clients in
biomedical intellectual property disputes, particularly those involving
FDA issues. In addition, Jim is an adjunct faculty member at
Northeastern University, teaching in the Master of Science in
FOLEY Regulatory Affairs for Drugs, Biologics, and Medical Devices program.
HOAG LLP Prior to joining Foley Hoag in 2002, Jim spent five years with Johnson
James M. Flaherty, Jr. & Johnson, most recently as Regulatory Affairs Manager at the
Seaport West Codman neurosurgical division. Jim received his bachelor’s degree
155 Seaport Boulevard
Boston, Massachusetts 02210-2600 from Harvard University, MS degree in Regulatory Affairs and Health
jflaherty@foleyhoag.com email Policy (RAHP) from Massachusetts College of Pharmacy and Health
617 832 1256 phone
617 832 7000 fax Sciences, and JD degree from Suffolk University Law School, summa
w ww.foleyhoag.com cum laude. Jim has held the Certified Regulatory Affairs Professional
(RAC) designation of the Regulatory Affairs Professional Society
(RAPS) since 1997.
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