10.16.13
FDA Gets Busy Before Government Shutdown Furloughs
September was a busy month for the U.S. Food and Drug Administration (FDA). Before the government shutdown on Oct. 1 emptied the agency of its employees, it awarded seven grants totaling more than $3.5 million to various pediatric device consortia to boost the development and availability of medical devices for children. The agency also issued a long-awaited final rule on the unique device identification (UDI) system, and a final guidance on medical mobile apps.
Grants Awarded to Stimulate Development of Pediatric Medical Devices
A panel of experts with experience in the clinical, business and regulatory aspects of pediatric device development reviewed
applications for grants to stimulate the development of pediatric medical devices, which will be administered by the FDA’s Office of Orphan Products Development (OOPD). Grant recipients primarily are physician researchers associated with
U.S. universities and hospitals.
“These consortia are part of FDA’s commitment to medical product innovation in areas of unmet medical need and will support pediatric medical device progression through all stages of development—concept formation, prototyping, preclinical, clinical, manufacturing, marketing and commercialization,” said Gayatri R. Rao, M.D., J.D., director of the FDA’s Office of Orphan Product Development. “At each stage, the consortia will assess and provide meaningful feedback about the scientific and medical merit of proposed pediatric device projects.”
Children differ in terms of size, growth and body chemistry, and present unique challenges to device developers. In addition, the activity level and ability to manage some implantable or long-term devices may vary greatly among children. While this program is administered by the OOPD, it is intended to encompass devices used in all pediatric diseases, not just rare diseases.
Medical device legislation passed by Congress in 2007 established funding to be distributed as grants for nonprofit
consortia to help stimulate projects to promote the development and availability of pediatric devices. This legislation was re-authorized as part of the FDA Safety and Innovation Act of 2012.
Those receiving grants will encourage innovation and connect qualified individuals with good pediatric device ideas to potential manufacturers; mentor and manage pediatric device projects through their development, including prototype design and marketing; connect innovators and physicians to existing federal and non-federal resources; and assess the scientific and medical merit of proposed pediatric projects and provide assistance and advice on business development, training, prototype development and post-marketing needs.
This is the third time since 2009 that the FDA has awarded grants to consortia that advance the development of pediatric medical devices. This year’s awards have been granted to groups that each bring together teams with excellence and expertise in delivering business, regulatory, legal, scientific, engineering, and clinical services for children. While a small portion of the grants fund specific projects, the real spirit of this grant program is to provide advisory resources to promote multiple projects, officials said.
Each of the grant recipients will coordinate among the FDA, device companies, and the National Institutes of Health’s
Eunice Kennedy Shriver National Institute of Child Health and Human Development to facilitate research and any necessary applications for device approval or clearance.
Along the way, the consortia will work collaboratively with the FDA to help innovators effectively navigate existing laws, regulations, and agency guidance to protect the health and safety of children.
Final Rule for UDI System
On Sept. 20, the FDA announced a final rule for the long-awaited UDI system.
Once implemented, the system, according to the agency, will provide a consistent way to identify medical devices.
The UDI system is designed to improve the quality of information in medical device adverse events reports, which will help industry and the FDA identify product problems more quickly, better target recalls and improve patient safety. Years in the making, the development of the UDI system involved collaboration among FDA, the medical device industry, the clinical community, as well as patient and consumer groups.
The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier also will include production-specific information such as the product’s lot or batch number, expiration date and manufacturing date when that information appears on the label.
The second component is a publicly searchable FDA database called the Global Unique Device Identification Database that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center, according to the agency.
The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.
Once fully implemented, the UDI system rule is expected to have many benefits for patients, the healthcare system and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It also will offer a clear way of documenting device use in electronic health records and clinical information systems.
“A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
The FDA issued the proposed rule requesting input from industry, the clinical community and patient and consumer groups in July last year.
According to FDA officials, the agency tried reduce the burden on industry by building upon systems already in place. The UDI system is a key component of the National Medical Device PostMarket Surveillance System proposed in September 2012.
In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year, and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act.
Included the announcement is the publication of a draft guidance for manufacturers outlining how to submit information to the database. The Advanced Medical Technology Association (AdvaMed), the industry’s largest trade group, was quick to
respond to the announcement.
Janet Trunzo, senior executive vice president of technology and regulatory affairs for AdvaMed said the group was still reviewing the final version, but commended the FDA for addressing many of the issues that industry raised in the proposed rule.
“We have long supported a UDI system for medical devices that, if appropriately implemented, holds the promise of more accurate and useful post-market surveillance and more rapid medical technology improvements. And this rule is a good step toward achieving that goal,” Trunzo said. “We are pleased that FDA recognizes the difficulty and limited benefit of direct marking of implants and has eliminated this requirement. Similarly, we commend FDA for concluding that multiple single-use devices within multi-packs only need the UDI on the multi-pack and not the individual device.”
One of the industry’s concerns was that many manufacturers will have extensive inventories of product when the UDI rule goes into effect. Trunzo said she was “encouraged” that FDA understands this issue and will allow an additional three years for inventories to be depleted.
“Also, in line with industry recommendations, FDA acknowledges that one year may not be enough time to implement a UDI system for all Class III devices and will allow firms to petition to extend the implementation period based on public health and supply disruption issues,” Trunzo added. “Finally, while FDA recognizes the ISO date format is more appropriate than their proposed American format, we are puzzled that the final rule includes the day of the month for expiration dates when expiration date testing generally does not include the day of the month.”
Final Guidance on Mobile Apps
On Sept. 26, FDA issued a final guidance for developers of mobile medical applications, or apps, software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s tailored approach to mobile apps.
According to the agency, the FDA will not enforce Federal Drug & Cosmetic Act requirements across the board for apps; rather it will enforce rules with discretion, as most apps are of minimal risk to consumers. The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.
“Mobile apps have the potential to transform healthcare by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional healthcare settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it,” read an FDA statement released on Sept. 23. Mobile medical apps currently on the market can, for example, diagnose abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes. “Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly,” said Shuren.
“The FDA’s tailored policy protects patients while encouraging innovation.”
The FDA is focusing its oversight on mobile medical apps that:
The agency does not regulate the sale or general consumer use of smartphones or tablets nor does it regulate mobile app distributors such as the iTunes App store or the Google Play store.
September was a busy month for the U.S. Food and Drug Administration (FDA). Before the government shutdown on Oct. 1 emptied the agency of its employees, it awarded seven grants totaling more than $3.5 million to various pediatric device consortia to boost the development and availability of medical devices for children. The agency also issued a long-awaited final rule on the unique device identification (UDI) system, and a final guidance on medical mobile apps.
Grants Awarded to Stimulate Development of Pediatric Medical Devices
A panel of experts with experience in the clinical, business and regulatory aspects of pediatric device development reviewed
applications for grants to stimulate the development of pediatric medical devices, which will be administered by the FDA’s Office of Orphan Products Development (OOPD). Grant recipients primarily are physician researchers associated with
U.S. universities and hospitals.
“These consortia are part of FDA’s commitment to medical product innovation in areas of unmet medical need and will support pediatric medical device progression through all stages of development—concept formation, prototyping, preclinical, clinical, manufacturing, marketing and commercialization,” said Gayatri R. Rao, M.D., J.D., director of the FDA’s Office of Orphan Product Development. “At each stage, the consortia will assess and provide meaningful feedback about the scientific and medical merit of proposed pediatric device projects.”
Children differ in terms of size, growth and body chemistry, and present unique challenges to device developers. In addition, the activity level and ability to manage some implantable or long-term devices may vary greatly among children. While this program is administered by the OOPD, it is intended to encompass devices used in all pediatric diseases, not just rare diseases.
Medical device legislation passed by Congress in 2007 established funding to be distributed as grants for nonprofit
consortia to help stimulate projects to promote the development and availability of pediatric devices. This legislation was re-authorized as part of the FDA Safety and Innovation Act of 2012.
Those receiving grants will encourage innovation and connect qualified individuals with good pediatric device ideas to potential manufacturers; mentor and manage pediatric device projects through their development, including prototype design and marketing; connect innovators and physicians to existing federal and non-federal resources; and assess the scientific and medical merit of proposed pediatric projects and provide assistance and advice on business development, training, prototype development and post-marketing needs.
This is the third time since 2009 that the FDA has awarded grants to consortia that advance the development of pediatric medical devices. This year’s awards have been granted to groups that each bring together teams with excellence and expertise in delivering business, regulatory, legal, scientific, engineering, and clinical services for children. While a small portion of the grants fund specific projects, the real spirit of this grant program is to provide advisory resources to promote multiple projects, officials said.
Each of the grant recipients will coordinate among the FDA, device companies, and the National Institutes of Health’s
Eunice Kennedy Shriver National Institute of Child Health and Human Development to facilitate research and any necessary applications for device approval or clearance.
Along the way, the consortia will work collaboratively with the FDA to help innovators effectively navigate existing laws, regulations, and agency guidance to protect the health and safety of children.
Final Rule for UDI System
On Sept. 20, the FDA announced a final rule for the long-awaited UDI system.
Once implemented, the system, according to the agency, will provide a consistent way to identify medical devices.
The UDI system is designed to improve the quality of information in medical device adverse events reports, which will help industry and the FDA identify product problems more quickly, better target recalls and improve patient safety. Years in the making, the development of the UDI system involved collaboration among FDA, the medical device industry, the clinical community, as well as patient and consumer groups.
The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier also will include production-specific information such as the product’s lot or batch number, expiration date and manufacturing date when that information appears on the label.
The second component is a publicly searchable FDA database called the Global Unique Device Identification Database that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center, according to the agency.
The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.
Once fully implemented, the UDI system rule is expected to have many benefits for patients, the healthcare system and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It also will offer a clear way of documenting device use in electronic health records and clinical information systems.
“A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
The FDA issued the proposed rule requesting input from industry, the clinical community and patient and consumer groups in July last year.
According to FDA officials, the agency tried reduce the burden on industry by building upon systems already in place. The UDI system is a key component of the National Medical Device PostMarket Surveillance System proposed in September 2012.
In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year, and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act.
Included the announcement is the publication of a draft guidance for manufacturers outlining how to submit information to the database. The Advanced Medical Technology Association (AdvaMed), the industry’s largest trade group, was quick to
respond to the announcement.
Janet Trunzo, senior executive vice president of technology and regulatory affairs for AdvaMed said the group was still reviewing the final version, but commended the FDA for addressing many of the issues that industry raised in the proposed rule.
“We have long supported a UDI system for medical devices that, if appropriately implemented, holds the promise of more accurate and useful post-market surveillance and more rapid medical technology improvements. And this rule is a good step toward achieving that goal,” Trunzo said. “We are pleased that FDA recognizes the difficulty and limited benefit of direct marking of implants and has eliminated this requirement. Similarly, we commend FDA for concluding that multiple single-use devices within multi-packs only need the UDI on the multi-pack and not the individual device.”
One of the industry’s concerns was that many manufacturers will have extensive inventories of product when the UDI rule goes into effect. Trunzo said she was “encouraged” that FDA understands this issue and will allow an additional three years for inventories to be depleted.
“Also, in line with industry recommendations, FDA acknowledges that one year may not be enough time to implement a UDI system for all Class III devices and will allow firms to petition to extend the implementation period based on public health and supply disruption issues,” Trunzo added. “Finally, while FDA recognizes the ISO date format is more appropriate than their proposed American format, we are puzzled that the final rule includes the day of the month for expiration dates when expiration date testing generally does not include the day of the month.”
Final Guidance on Mobile Apps
On Sept. 26, FDA issued a final guidance for developers of mobile medical applications, or apps, software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s tailored approach to mobile apps.
According to the agency, the FDA will not enforce Federal Drug & Cosmetic Act requirements across the board for apps; rather it will enforce rules with discretion, as most apps are of minimal risk to consumers. The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.
“Mobile apps have the potential to transform healthcare by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional healthcare settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it,” read an FDA statement released on Sept. 23. Mobile medical apps currently on the market can, for example, diagnose abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes. “Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly,” said Shuren.
“The FDA’s tailored policy protects patients while encouraging innovation.”
The FDA is focusing its oversight on mobile medical apps that:
- Are intended to be used as an accessory to a regulated medical device; or
- Transform a mobile platform into a regulated medical device.
The agency does not regulate the sale or general consumer use of smartphones or tablets nor does it regulate mobile app distributors such as the iTunes App store or the Google Play store.