MDDI_Medical Device & Diagnostic Industry

MDDI, June 2014

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Washington Wrap-Up 20 | JUNE 2014 mddionline.com FDA Seeks Input on Health IT Regulations FDA wants stakeholders to help further define the regulatory lines on what func- tionalities will fit in less-regulated health information technology (IT) categories based on a new health IT draft report released in April. CDRH senior policy advisor Bakul Patel said in a webcast outlining the report that the agency planned a public workshop in May at which officials would "go deeper into this discussion about functionality." Based on comments to the report and feedback at the workshop, Patel said, FDA will publish a guidance clarifying the cat- egory of devices that the agency will regu- late because these could potentially pose greater risks to patients if they do not per- form as intended. The report contains a proposed strategy and recommendations for a health informa- tion technology framework that promotes product innovation, maintains appropriate patient protections, and avoids regulatory duplication, Patel said. The report was developed by FDA in consultation with the HHS Office of the Na- tional Coordinator for Health IT (ONC) and the Federal Communications Commission. "The report fundamentally latches onto principles of functionality because tech- nology like smartphones will change and evolve," Patel noted during the webcast. The report proposes three health IT cat- egories based on functionality and level of risk. The categories would focus on what a product does, rather than the platform on which it operates. According to Patel, the first category contains products with administrative health IT functions, poses little or no risk to patient safety, and would require no additional oversight. The second category houses products with health management and health IT functions, and includes software for health information and data management, medi- cation management, provider order entry, knowledge management, electronic access to clinical results, and most clinical deci- sion support software. The report says these products are of sufficiently low risk that if they meet the statutory definition of a med- ical device, FDA does not intend to focus its oversight on them. The third category targets products with medical device health IT functions that could potentially pose greater risks to pa- tients if they do not preform as intended. The draft report proposes that FDA con- tinue regulating these products, which in- clude computer-aided detection software, software for bedside monitor alarms, and radiation treatment software. Patel also emphasized four key priority areas identified in the proposed health IT strategy: promote use of quality management principles; identify, develop, and adopt standards and best practices; leverage conformity assessment tools; and create an environment of learning and continual improvement. UDI Exceptions Guide CDRH has posted on its unique device iden- tification Web site information on request- ing unique device identifier (UDI) excep- tions, alternatives, and time extensions. The page outlines the processes device labelers may use to request the following: ■ An exception from or alternative to a UDI requirement under 21 CFR 801 Subpart B (labeling requirements for UDI). ■ An extension of the UDI compliance date for a Class III medical device or a device licensed under the Public Health Service Act. These requests are due by June 23. ■ Continued use of an FDA labeler code. These requests are due by September 24. Draft Guidance Suggests Endotoxin Limit for Intraocular Devices A new FDA draft guidance provides medi- cal device makers with a recommended endotoxin limit for the release of intraocu- lar devices and single-use intraocular oph- thalmic surgical instruments/accessories. The document, Endotoxin Testing Rec- ommendations for Single-Use Intraocular Ophthalmic Devices—Draft Guidance for Industry and Food and Drug Administration Staff, says the recommended limit for all posterior segment solid intraocular devices is ≤0.5 endotoxin units (EU) per device and ≤0.2 EUs per device for all anterior segment solid intraocular devices. The limits are FDA's newest effort to mitigate future toxic anterior segment syn- drome (TASS) outbreaks. TASS is a sterile inflammatory condition localized to the anterior segment of the eye following in- traocular surgery. "It has been associated with significant decreases in vision and has required additional surgical procedures, in- cluding corneal transplants and glaucoma surgery, to resolve some of its sequelae," the agency says. FDA Guidance on Communications During Device Reviews CDRH has issued a guidance to describe commitments made during the Medical De- vice User Fee Amendments of 2012 (MDUFA III) to provide further transparency for the medical device review process, including new communication commitments. The guidance also updates the agency's approach to interactive review to reflect commitments in the MDUFA III commit- ment letter and to incorporate an expanded use of that communication tool to increase review process efficiency. Sections in the guidance include accep- tance review communication, substantive interaction, interactive review, and missed MDUFA decision communication. Jim Dickinson is MD+DI's contributing editor. 2 Image courtesy of MKURTBAS/iSTOCKPHOTO.COM ES450969_MD1406_020.pgs 06.03.2014 02:40 UBM black yellow magenta cyan

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