NEW YORK and CAESAREA, Israel – The U.S. Food and Drug Administration has cleared the Lightning-enabled version of DarioHealth’s blood glucose monitoring system for use with the Dario app on iPhone 7, 8 and X smart mobile devices. “The launch of Apple’s smartphones with only a Lightning connector posed a unique challenge to the entire mobile ecosystem,” said Erez Raphael, chairman and CEO of DarioHealth, in a statement. “This news opens a significant U.S. market opportunity for DarioHealth, as it enables us to provide our diabetes management platform and expand the sales of the Dario Blood Glucose Monitoring System. This continues DarioHealth’s U.S. market progress and truly opens the door for wide-scale expansion in this pivotal market.”
WASHINGTON – The U.S. Food and Drug Administration approved an at-home test that screens for several breast and ovarian cancer genes through the genetic testing company 23andMe. It is the first direct-to-consumer test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The test only detects three out of more than 1,000 known BRCA mutations and a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk. “This test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening and is a step forward in the availability of DTC genetic tests” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a statement. St. Pierre said the FDA approval comes with several caveats, and consumers and health care professionals should not use the test results to determine any treatments. The test report provides information describing what the results might mean, how to interpret results and where additional information about the results may be found. The FDA reviewed data for the test through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.
WASHINGTON – Health experts are optimistic about the U.S. Food and Drug Administration’s guidance documents on digital health oversight released in December.
“These guidance documents take us one step closer to seeing a full integration of digital health into our lives,” said Kevin Madagan, a partner in Reed Smith LLP’s Life Sciences Health Industry Group.
The three guidance documents—two draft and one final—cover clinical decision support, changes to medical software policy based on congressional mandates in the 21st Century Cures Act, and Software as a Medical Device.
The draft guidance on clinical decision support, which has been six years in the making, clarifies which types of clinical decision support and patient decision support software the FDA defines as a medical device in need of agency oversight.
In a nutshell: Analytics technology intended to support clinical diagnoses that provides room for a physician to independently review the basis of the software’s recommendations would not be regulated by the FDA; however, software that analyzes medical images or laboratory or medical tests would remain regulated.
“This guidance, even in draft form, removes significant ambiguity,” said Madagan. “Until now, we didn’t know where the FDA would draw the line on CDS functions it would regulate, or whether they would ever agree to enforcement discretion for PDS.”
The other draft guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices. Among them: certain mobile apps.
“We’re making clear that certain digital health technologies—such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of the FDA’s guidance,” said Scott Gottlieb, FDA Commissioner, in a statement.
The final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product.
Though the FDA guidance documents provide more clarity on digital health, Madagan said there is much work left to do.
“With advancements in digital applications being integrated into medical devices, and now even drugs, the digital oversight and real-time tracking of our health is just beginning,” he said. “And this doesn’t even account for the potential of artificial intelligence.”
WASHINGTON – The U.S. Food and Drug Administration approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite has an ingestible sensor embedded in the pill that records that the medication was taken. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers,” said Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research. The system works by sending a message from the pill’s sensor to a wearable patch, which transmits the information to a mobile app so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.
SILVER SPRING, Md. – The U.S. Food and Drug Administration has announced the names of the companies selected to participate in its Pre-cert pilot program aimed at streamlining the agency’s approach toward digital health technology.
The pilot participants include Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsun, Tidepool, and Verily.
“These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product,” said Dr. Scott Gottlieb, FDA Commissioner, in a statement.
The goal of the Pre-cert program is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to pre-certify it.
With the information gleaned through the pilot, the agency hopes to determine the key metrics and performance indicators for pre-certification and identify ways that pre-certified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal program.
The FDA is also considering, as part of the pilot program, whether and how, pre-certified companies may not have to submit a product for pre-market review in some cases.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” said Gottlieb. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices.”
The FDA received interest in the program from more than 100 companies. In selecting the participants, the agency considered several factors including company size, demonstrated record of quality and organizational excellence, clinical focus area and the risk profile of the product. The FDA’s selection process identified companies that represent different perspectives and unique approaches to digital health technology development.
“We are extremely appreciative of the tremendous interest in participating in the FDA Pre-cert pilot program,” said Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, in a statement. “The number of applicants speaks to the significant impact this approach could have on facilitating timely advancement of software that has the potential to benefit health.”
As part of the Pre-cert pilot program, participants have agreed to provide access to measures they currently use to develop, test and maintain their software products, including ways they collect post-market data. Participants also agreed to be available for site visits from FDA staff, and provide information about their quality management system.
The FDA plans to share public updates about the Pre-cert pilot program via the pilot program webpage, as well as through stakeholder meetings, including a January 2018 workshop.
WASHINGTON – The U.S. Food and Drug Administration recently unveiled a pre-certification pilot program for digital health technology, and industry leaders are optimistic the program will speed up the process of getting new innovations safely into the hands of consumers and providers.
“Under the FDA’s new program, American innovators will have greater flexibility to create the health and wellness tech solutions that are already monitoring personal health and helping doctors treat patients more efficiently,” said Julie Kearney, vice president of regulatory affairs for the Consumer Technology Association.
As part of the agency’s Medical Innovation Access Plan announced in July, the Pre-Cert for Software Pilot will review a digital health technology company’s systems for software design, validation and maintenance, and if it meets the necessary quality standards, pre-certify it. Pre-certified companies may be able to submit less information to the FDA than is currently required before marketing a new digital health tool, said Dr. Scott Gottlieb, comissioner of the FDA, in a recent blog post announcing the pilot.
The FDA’s new approach allows the federal government to keep up with the industry’s fast pace of innovation, while preserving consumer safety, industry leaders say.
“The FDA’s traditional approach to medical devices is not well suited to these products,” said Gottlieb. “We need a regulatory framework that accommodates the distinctive nature of digital health technology.”
The Advanced Medical Technology Association is optimistic about the pilot, said Janet Trunzo, senior executive vice president, technology and regulatory affairs.
“If properly implemented, the program has the potential to reduce pre- and post-market burdens for both software developers and FDA,” she said.
Applications for the pilot are currently being accepted and the FDA will choose nine companies to participate, ranging from small startups to large companies that develop both high- and low-risk devices. The agency will report on its findings next January.
The U.S. Food and Drug Administration recently announced that it would begin using in silico clinical trials at its Center for Devices and Radiological Health as a way to help facilitate access to new innovations once the agency approves them.
The use of in silico trials, which use computer models and simulations to develop and evaluate devices and drugs, is part of the FDA’s plan to implement the 21st Century Cures Act, passed by Congress in December 2016.
Industry leaders are cautiously applauding the announcement.
Yoram Vodovotz PhD of the University of Pittsburgh/University of Pittsburg Medical Center’s McGowan Institute For Regenerative Medicine has used in silico trials in his own work, and has written of their benefits.
“In silico study in medicine is thought to have the potential to speed the rate of discovery while reducing the need for expensive lab work and clinical trials,” he said.
With regard to medical devices, the FDA’s in silico trial plans include the development of a digital library of models and a family of “virtual patients” for device testing, all while seeking consistency.
“We need to make sure that the adoption of these strategies is consistent across different medical products and across the agency,” said Scott Gottlieb, FDA Commissioner, in a recent blog post about the in silico trials.
The passing of the Cures act gave the FDA a wealth of resources and authorities, including $500 million over nine years. In silico trials are a way to forge a quicker path for breakthrough technologies to reach patients who may desperately need them.
“Access to advances in medical care is a critical component of public health,” said Gottlieb. “And the price of new technology affects the ability of people to access these new treatments. We therefore need to be mindful of the costs of our regulatory processes, to the degree that these costs also affect the availability of new innovations, and the way that they are ultimately priced.”
It’s encouraging to see the agency look for ways to be good stewards of what they’ve got in the interest of advancing health outcomes for everyone.
SILVER SPRING, Md. – Dr. Scott Gottlieb, commissioner of the U.S. Food & Drug Administration, recently revealed the agency’s plans to establish a more efficient approach to digital health device regulation—and industry experts are cautiously optimistic.
“The streamlined certification process is a step in the right direction,” said Xu Zou, CEO of Internet of Things security software provider ZingBox.
Gottlieb’s Digital Health Innovation Plan calls for the government to establish public health policies that are clear enough for developers to apply on their own, without having to seek out the FDA’s position on every technology change or software development on a case-by-case basis.
“Smart devices make streamlining the FDA’s approval process a necessity,” said Jacques Touillon, CEO and co-founder of Airboxlab, maker of smart air quality monitoring devices.
“The current system worked when changing the function of a device meant shipping a whole new product, but today developers can add entirely new features to a product as it sits on a user’s nightstand, simply by updating the software over the Internet,” he said.
In his blog post that laid out the new plans, Gottlieb said the FDA will establish guidelines specifying the boundaries around low-risk technologies like some mobile health apps and clinical administrative support software. In addition, the agency will add other technologies that could be considered low-risk.
The commissioner also described a new third-party certification pilot program, still under development, under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA premarket review.
Zou said that while the FDA’s plans may help streamline the certification process, device security must be a top priority.
“History has shown that where new features and innovation go, so do the hackers and malware,” he said. “As the requirements of FDA certification relaxes, device manufacturers and health care providers must plan for the additional security needed to protect the more feature-rich devices.”
During a recent interview with reporter Dan Gorenstein of Marketplace, I shared with him that the U.S. Food & Drug Administration approved 15,000 medical devices from 2012-2016, with over 2,900 medical devices approved in 2016 alone (according to EmergoGroup). In researching that statistic, I learned some other fun facts about the FDA approval process.
Did you know that the average medical device approval from the FDA takes an average of 177 days? Neither did I.
Did you know that all 510(K) submissions are assigned a “K number” – the letter K followed by six digits? The first two digits of the 510(K) number indicate the year it was submitted for review. The next four digits are sequential starting at 0 and indicate the order in which the submission was received during the year.
Did you know that the first 510(K) ever submitted was by Zimmer Inc., which holds K760001, submitted on May 26, 1976.
Did you know that Boston Scientific Scimed Inc. owns K000001? It’s not the first 510(K) ever, but it was the first one submitted in the new millennium on January 3, 2000.
I’m sure 2017 will see it’s share of medical device approval submissions to the FDA and I’m sure we’re going to learn about some incredible technologies to help improve the way home health care is delivered. I’ll try to cover most of it right here, so stay tuned!
Thanks to medical device consultants EmergoGroup for the FDA fun facts.
SILVER SPRING, Md. – The U.S. Food and Drug Administration has released draft guidance on the requirements for clinical evaluation of software-as-a-medical-device (SaMD). The draft guidance is intended to provide “globally harmonized” principles around when and what type of clinical evaluation is appropriate. “Based on the significant impact SaMD has on clinical outcomes and patient care, a SaMD manufacturer is expected to gather, analyze and evaluate data, and develop evidence to demonstrate the assurance of safety, effectiveness and performance of the SaMD,” the guidance states. Public comment on the draft guidance is being accepted.