The Food and Drug Administration should clarify its policy...
The Food and Drug Administration should clarify its policy on medical mobile apps, said six senators in a Wednesday letter to the FDA (http://1.usa.gov/OAUDGe). “It is important for the FDA to be well-equipped with the proper tools to be able…
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to advance public health while taking care that innovation is not stifled through uncertainty or over-regulation,” said Sens. Michael Bennet, D-Colo.; Orrin Hatch, R-Utah; Tom Harkin, D-Iowa; Lamar Alexander, R-Tenn.; Mark Warner, D-Va.; and Richard Burr, R-N.C. The FDA uses a “risk-based approach” to define medical mobile devices, they said. “Given that a large number of medical mobile applications could be actively regulated under the statute using this definition, we appreciate the FDA’s decision to use a risk-based approach to regulation.” Despite “clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated,” wrote the senators. Association for Competitive Technology (ACT) Executive Director Morgan Reed said transparency will aid industry. “It is important that government and industry become better informed about health apps that are improving patient outcomes,” Reed said in a statement. ACT works with small- and medium-size app developers to help them comply with government regulation. “We are already seeing remarkable results in chronic disease care through the use of smartphones and tablets,” said Reed. “The regulatory environment will be a critical factor in determining how patients may best use mobile devices to monitor their health and communicate with healthcare providers.” The FDA and FTC share jurisdiction over healthcare data security, which some believe creates industry-stifling uncertainty. Consumer advocates have proposed granting the FTC sole jurisdiction in this area because of what they call the commission’s superior technical expertise, while other industry officials have pushed for the FDA to receive sole oversight due to its sector-specific expertise. FDA had no comment.