A Wakeup Call from FDA
FDA's release of the Draft Guidance on "Mobile Medical Applications" on July 21, 2011 is a wakeup call to the wireless industry. FDA has asserted broad jurisdiction over this industry, even though the Draft Guidance calls FDA's regulatory approach "narrowly-tailored." FDA cedes no ground on what it may regulate in the future. At this time, the Agency is exercising its enforcement discretion against all other apps that fall under its jurisdiction. The approach is similar to FDA's erratic approach to the regulation of computer software, which has provided no clarity to the industry in the three decades that policy has been in evolution.
The Draft Guidance defines key terms such as "mobile platform," "mobile app," and "mobile medical app." Today, FDA intends only to regulate mobile medical apps that impact or may impact the function or performance of a medical device that is already regulated. These include mobile medical apps that are either:
FDA seeks comment specifically on the difficulties of regulating a mobile medical app as an accessory. You must review the listed examples to guide your future development efforts, including funding.
FDA also intends to monitor how "other mobile apps" not listed in the Draft Guidance perform to determine if further regulatory actions are needed. How far FDA's regulatory reach will extend in practice is unclear, but the risk averse atmosphere at the Agency puts everyone at risk.
For example, FDA has created a broad definition for "mobile medical app manufacturer" that includes many different entities, and is based upon FDA's existing device regulations that define "manufacturer." Again, FDA's examples prove that it intends to apply the term very broadly. It is also unclear how the Agency will apply device classifications, review requirements, or other standards to the industry.
Finally, FDA "strongly recommends" that manufacturers of all apps that could be within FDA's jurisdiction comply with Quality Systems Regulations - device good manufacturing practices.
Significant questions remain about the actual scope of FDA's legal authority, but as with software, once FDA gains a foothold in the regulation of mobile medical apps, the Agency will expand its reach and regulation.
FDA invites comments from industry on the regulatory approach in its Draft Guidance by October 19, 2011. Now is the time for parties involved in the everyday business of mobile medical apps to provide FDA with their own real-world perspective about how to regulate this technology. For further information, please contact Edward John Allera (202-452-7985; edward.allera@bipc.com) or Barbara A. Binzak (202-452-7906; barbara.binzak@bipc.com).
The Draft Guidance defines key terms such as "mobile platform," "mobile app," and "mobile medical app." Today, FDA intends only to regulate mobile medical apps that impact or may impact the function or performance of a medical device that is already regulated. These include mobile medical apps that are either:
- Used as accessories to a regulated medical device; or
- Transform a mobile device into a regulated medical device.
FDA seeks comment specifically on the difficulties of regulating a mobile medical app as an accessory. You must review the listed examples to guide your future development efforts, including funding.
FDA also intends to monitor how "other mobile apps" not listed in the Draft Guidance perform to determine if further regulatory actions are needed. How far FDA's regulatory reach will extend in practice is unclear, but the risk averse atmosphere at the Agency puts everyone at risk.
For example, FDA has created a broad definition for "mobile medical app manufacturer" that includes many different entities, and is based upon FDA's existing device regulations that define "manufacturer." Again, FDA's examples prove that it intends to apply the term very broadly. It is also unclear how the Agency will apply device classifications, review requirements, or other standards to the industry.
Finally, FDA "strongly recommends" that manufacturers of all apps that could be within FDA's jurisdiction comply with Quality Systems Regulations - device good manufacturing practices.
Significant questions remain about the actual scope of FDA's legal authority, but as with software, once FDA gains a foothold in the regulation of mobile medical apps, the Agency will expand its reach and regulation.
FDA invites comments from industry on the regulatory approach in its Draft Guidance by October 19, 2011. Now is the time for parties involved in the everyday business of mobile medical apps to provide FDA with their own real-world perspective about how to regulate this technology. For further information, please contact Edward John Allera (202-452-7985; edward.allera@bipc.com) or Barbara A. Binzak (202-452-7906; barbara.binzak@bipc.com).
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