Update Nov Dec 2013 - (Page 23)

Enforcement plan for radiation therapy, and apps that run Computer Aided Detection software (CAD) to analyze radiological images to determine the presence of cancerous cells. Need Regulatory Help? Conclusion The Final Guidance has brought clarity to the mHealth industry. However, there remain unchartered waters. The Final Guidance does not address clinical decision support software. Nor does it define the concept of "accessories" to medical devices. Overall the Final Guidance on mobile medical apps has cut through some of the fog and clouds around mHealth products, and FDA has provided the public better visibility of which apps will or will not be regulated. This will likely smooth the path for more innovative products and better healthcare. 1. 2. 3. 4. 5. FDLI Mobile Medical Applications Final Guidance Note: The fact that the Final Guidance uses the term "distributor" is not an issue anymore because FDA deleted the proposed language from the Draft Guidance whereby distributors had post-market obligations to work with manufacturers in conducting corrections and removals. 21 CFR Sec. 862.9 provides limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act. In September 2011, the FDA provided a preliminary definition of CDS software that broadly included any software that converts patient-specific information into actionable results through the use of formulae or other forms of analysis. On September 23, the FDA announced the Final Guidance and held a briefing with stakeholders of the mHealth industry. Dr. Jeffrey Shuren, Director of FDA's Center for Devices and Radiological Health (CDRH), announced that CDS software will be addressed separately, in an FDA Safety and Innovation Act-mandated report due in January in which FDA, the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology will propose a regulatory framework for health IT. Specializing in FDA Regulatory Matters Consulting * Auditing * Training St affe d w it h for me r FDA C ompli anc e and Insp e c t i on Offi c i a ls Pharmaceuticals Dietary Supplements Medical Devices Foods Cosmetics Biologics Veterinary Products Tobacco Products EAS Consulting Group, LLC (571) 447-5500 www.easconsultinggroup.com November/December 2013 Update 23 http://www.easconsultinggroup.com

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013