FDA www.fda.gov has awarded 15 grants totaling more than $19 million to boost the development of medical devices, drugs, and biological products for patients with rare diseases. At least a quarter of the funding will go to studies focusing solely on pediatrics.
The grant program is administered through the FDA’s Orphan Products Grants Program www.fda.gov/newsEvents/Newsroom/PressAnnouncements/ucm416738.htm to promote the development of products for rare diseases. Since its inception, the program has given more than $330 million to fund more than 530 new clinical studies to work on developing treatments for rare diseases and so far, has approved more than 50 products.
The 2014 grant recipients include Cincinnati Children’s Hospital Medical Center, Mayo Clinic Arizona, University of Texas Health Center San Antonio, Johns Hopkins University, University of California San Diego, Stanford University, Mayo Clinic Rochester, River Vision Development Corporation, Seattle Children’s Hospital, City of Hope Beckman Research Institute, Selexys Pharmaceuticals Corporation, Wayne State University, and Aesrx LLC.
FDA is also taking steps to more effectively manage cybersecurity risks and published their final guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices www.fda.gov/MedicalDevices/NewsEvents/News/default.htm.
FDA recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device and submit documentation to FDA on the risks that have been identified and the controls in place to mitigate those risks. The guidance also recommends that manufacturers submit their plans for providing patches and updates to operating systems and medical software.
FDA’s concerns about cybersecurity vulnerabilities include malware infections on network-connected medical devices or computers. FDA is concerned about smartphones, and tablets used to access patient data, unsecured or uncontrolled distribution of passwords, failure to provide timely security software updates and patches to medical devices and networks, and security vulnerabilities in off-the-shelf software designed to prevent unauthorized access to the device or network.
FDA has been working closely with other federal agencies and the medical device industry to identify and communicate with stakeholders about vulnerabilities. FDA is planning a public workshop this fall to discuss how government, medical device developers, hospitals, cybersecurity professionals, and other stakeholders can collaborate to improve the cybersecurity of medical devices.