It's been said that the best way to get information is to go to the source. That's why last week FierceMobileHealthcare spoke with Bakul Patel, Senior Policy Advisor to the Director of the FDA's Center for Devices and Radiological Health. Patel, for those that might not know, is the primary author of the FDA's draft guidance on mobile medical applications that the agency issued in July 2011.
As we can all agree, the FDA has taken way too long in finalizing its guidance (which is now expected by the end of fiscal 2013) and in the process has caused wide-spread confusion for the mHealth industry and created an environment of uncertainty for application developers. By interviewing Patel, I had hoped to get a better understanding of the FDA's regulatory oversight and review of mobile medical apps as the agency continues to finalize its guidance.
It's not like I expected Patel to disclose the agency's current thinking on the subject that isn't already in the public domain, nor did I believe he might tip his hand one way or another as to how the FDA final guidance might be substantively different than its draft guidance. However, I walked away from the interview no clearer about the regulators' intentions.
"The idea behind the [draft] guidance was to clarify and even scale back the definition [of a medical device]," Patel told me. "In our proposed policy, we're actually scaling back to allow innovation to happen in areas that are more beneficial to patients." Yet, he admitted that the overwhelming feedback the FDA received in its public meetings regarding its 2011 draft guidance was that people "wanted a lot more clarity," something Patel said the agency heard "loud and clear."
Nevertheless, a cottage industry is springing up to help try to bring clarity to the FDA's ambiguous regulations while the marketplace awaits the agency's final guidance. Last week, a new consulting firm launched a "regulatory coaching service" for mobile medical application startups to ensure their success by understanding the costs and requirements of FDA regulation. Called the Tenzing Group, the goal of the Santa Clara, Calif.-based firm is to "decrease the amount of companies that may fail due to regulatory costs and help the mHealth market thrive."
The burgeoning mobile healthcare industry can use all the help it can get in clearing up the confusion about where the FDA stands on mobile medical applications in order to better predict the agency's approach. Case in point: Indian start-up Biosense Technologies Private Limited, developer of the uChek Urine analyzer, received a letter last week from the FDA warning the company that their iPhone application appears to meet the definition of a device, marking the first time the agency has sent such a letter to an app developer.
The FDA gave the company 30 days to explain why their product should not be required to obtain 510(k) clearance. Although Biosense co-founder Abhishek Sen is quoted in a Bloomberg article saying that the company plans to work with the agency in order to resolve the issue over the coming months, this could be the beginning of a broader crackdown on apps by regulators. If so, Biosense and other developers might want to give the Tenzing Group a call. - Greg (@Slabodkin)