Games for Health (gft12) FDA Presentation

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.© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 4

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© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 5

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© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 6

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© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 7

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.© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 10

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.”© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 11

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© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 12

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)© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 13

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© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 14

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© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 15

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© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 16

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© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 17

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?© 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 18

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 inFOLEY Regulatory Affairs for Drugs, Biologics, and Medical Devices program.HOAG LLP Prior to joining Foley Hoag in 2002, Jim spent five years with JohnsonJames M. Flaherty, Jr. & Johnson, most recently as Regulatory Affairs Manager at theSeaport West Codman neurosurgical division. Jim received his bachelor’s degree155 Seaport BoulevardBoston, Massachusetts 02210-2600 from Harvard University, MS degree in Regulatory Affairs and Healthjflaherty@foleyhoag.com email Policy (RAHP) from Massachusetts College of Pharmacy and Health617 832 1256 phone617 832 7000 fax Sciences, and JD degree from Suffolk University Law School, summaw ww.foleyhoag.com cum laude. Jim has held the Certified Regulatory Affairs Professional (RAC) designation of the Regulatory Affairs Professional Society (RAPS) since 1997. © 2012 Foley Hoag LLP. All Rights Reserved. Games for Health 2012 | 19

Games for Health (gft12) FDA Presentation

by jamesmflahertyjr on Jun 29, 2012

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Games for Health (gft12) FDA Presentation Presentation Transcript