HL7 International January Working Group Meeting Health Care Device WG FDA Update HL7 International January Working Group Meeting Health Care Device WG

FDA Update and Medical Devices FDA Final Guidance on Regulating Mobile Medical Applications New Bi-Partisan Bill Defines Clinical and Health Apps Exempt from FDA Oversight 23 and Me: Personal Genome Service assessed in violation of FDA rules Unique Device Identification Rule

23 and Me: Personal Genome Service assessed in violation of FDA rules FDA sent a warning letter to 23andMe that some of its services are regulated by FDA as a medical device and it is out of compliance. FDA is concerned 23andMe provides health info to consumers that may be misunderstood. Of particular interest is the info about the BRCA gene. Competitors sell only to clinicians. 23andMe complied with the FDA request. The firm is still selling and marketing the ancestry features of its $99 genomics service, and customers can download the raw data, but it no longer provides full health reports.

FDA Final Guidance on Regulating Mobile Medical Applications Mobile medical apps are software programs that run on mobile devices and provide the same functions as traditional medical devices. FDA focuses oversight in two areas: 1.Use as an accessory to a regulated medical device. Example: an imaging app from a PACS that physicians use to make a specific diagnosis. 2.Transform a mobile platform into a regulated medical device. Example, an app that turns a smartphone into an ECG machine to detect abnormal heart rhythms.

New Bi-Partisan Bill Defines Clinical and Health Apps Exempt from FDA Oversight Medical software. Intended to change the structure or any function of the body either directly, or indirectly via consumers following recommended clinical action without a healthcare provider. FDA oversight is OK. Clinical software. Clinical decision support software that recommends clinical action but doesn’t change the structure of any body function and is used by providers in clinical settings. No FDA oversight. Health software. Software that’s neither medical or clinical that deals with patient or population data in support of administrative aspects, not patient care, for the purpose of being a platform for secondary software for connectivity or storage. No FDA oversight.

Unique Device Identification Rule Background Section 226 of the FDA Amendments Act (FDAAA) of 2007 and Section 614 of the FDA Safety and Innovation Act (FDASIA) of 2012 amended the Federal Food, Drug, and Cosmetic Act to add section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices along with implementation timeframes for certain medical devices. The Unique Device Identifier (UDI) Proposed Rule was published on July 10, 2012, followed by an amendment, published on November 19, 2012, modifying the implementation time frame for certain devices. The UDI Final Rule was published on September 2013. | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only. November 14, 2018

What is a Unique Device Identifier (UDI ) ? Device Identifier ( DI ) - a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device ; and Production Identifier(s) – a conditional, variable portion of a UDI that identifies one or more of the following: Lot or Batch number within which a device was manufactured; Serial number of a specific device ; Expiration date of a specific device ; Date a specific device was manufactured | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only. November 14, 2018

Resources UDI website UDI Final Rule (unformated version) www.fda.gov/UDI UDI Final Rule (unformated version) https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system GUDID Draft Guidance http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf Ref: Terrie Reed, 2013 FDA | November 14, 2018