In many ways the gatekeepers of healthcare innovation and advancement in the US, the FDA is key in shaping the future of the healthcare industry both in America and abroad. When it comes to the digital space the FDA has been evolving both in the way technology is approved and vetted.
Over the last year FDA Commissioner Scott Gottlieb has put an emphasis on speeding up the process in getting technology and medications out to the public. This is evidenced by the new Pre-Cert program which would uproot the way software as a medical device is regulated, with the possibility of deeming a company safe instead of focusing on each individual product.
Here is a look at some of the biggest news out of the FDA in the last year:
Fast track to innovation? FDA’s Pre-Cert program
The FDA first introduced the idea for the Pre-Cert program in August of 2017, which proposes to allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process. This was followed by the launch of a pilot program, where nine companies of various sizes began developing programs using this pathway.
Big names like Johnson & Johnson, Apple and Fitbit were among the first companies to go through the Pre-Cert program. But it also included up and coming players in the field like Pear Therapeutics, which is working on a digital therapeutic to treat opioid addiction, and smaller entities like Tidepool, which helps people with diabetes track their patterns.
“Because of software’s faster iterative design, development, and validation, traditional implementation of the premarket requirements may impede or delay patient access to advances in software technology that would improve public health,” the FDA wrote in a ahead of the workshop in February. “Since issuing the action plan, we have partnered with a range of digital health software companies and other stakeholders to begin developing a precertification program that could replace the need for a premarket submission for certain medical software products and allow for a streamlined review of marketing submissions for others.”
The first version of the Pre-Cert program is scheduled to launch this December, but has already had input from stakeholders and the public.
Over the course of the year the FDA has released drafts of a working model for the program.
In late June the FDA released the second draft of its Pre-Cert framework, where it laid out 12 categories that the agency can look at when evaluating an organization. Those areas include leadership, transparency, people and risk management.
This second draft was released following a 17-page first draft in April. The first draft spells out two levels of pre-certifications within the software as a medical device (SaMD) space, one for companies with experience developing SaMD and another for businesses developing SaMD for the first time. However, in the latest draft the lines between the two levels are less set in stone; instead companies can test into either category regardless of past experience.
Right now it looks like developers will have the ability to opt into the Pre-Cert program and will be able to take the traditional route if they so choose. But some are questioning if this option will create a new norm for the industry.
If the pilot goes well and Pre-Cert discussions finalize in the future, startups could potentially go straight into the program before launching any products.
“If Pre-Cert is done the right way, then Pre-Cert becomes something you start with and that your funders will say, let’s go to the Pre-Cert concept from day one and you’ll have a quicker path to launch,” Morgan Reed, the President of ACT | The App Association, told Babyforyou.net.ua in February.
But the program certainly has its critics. Some fear that the Pre-Cert program would actually give the FDA more power over the industry.
“This is a good old-fashioned trade,” Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA law, said in an email to Babyforyou.net.ua in April after the first draft guidance. “Industry wants faster approvals. FDA wants more control over industry. So FDA’s proposing an exchange: faster approvals for more FDA authority.”
In a recent op-ed published in Babyforyou.net.ua, Thompson also highlighted that not all companies will be qualified to participate in the program due to the excellent standards set forth. He also called into question the FDA’s ability to inspect medical device establishments once through the program.
Regardless of the criticism, according to the , the agency is currently finalizing Pre-Cert 1.0 and integrating stakeholder feedback lessons learned and other input. The agency is also in the scenario testing phase, which will look at program objectives and lessons learned. By December the first version of the Pre-Cert program will be launched. At that time the organization will also be coming out with next steps for the program.
A new center for digital health
With more digital health companies cropping up across the country the FDA has announced plans to create a Center for Excellence for Digital Health with the goal of modernizing regulatory approach to help the industry while still protecting patients.
“This Center of Excellence would help establish more efficient regulatory paradigms, consider building new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices,” the .
The agency said the idea is to help developers create innovations that will benefit patients.
“With these advances has come a new swath of companies that are investing in these new opportunities,” the agency wrote. “These firms may be new to healthcare products and may be new to healthcare products and maybe not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas.”
The agency cited the latest medical apps launched by Apple yesterday, saying that the FDA worked closely with tech giant as they developed and tested the software. The statement went on to say that traditionally the healthcare industry has been behind the times when it comes to adopting new technologies, in part because of regulations.
“But momentum toward a universal digital future in healthcare is advancing. Due to the great promise of these technologies and the rapid pace of change,” the agency wrote, “the FDA is working to modernize our regulatory approach to better enable and more efficiently spur innovation in this novel area to improve the health and quality of life of consumers and patients.”
As consumer genomics companies like 23andMe and Helix continue to expand its reach, the regulations in this space have also been evolving.
After years in the grey zone, in June the FDA finally announced a new ruling that exempts individual genetic risk tests from 510(k) premarket approval. This means that companies, like 23andMe offering genetic risk tests, only have to go through a one-time premarket review of its testing apparatus.
Companies going through the new process will still need to meet the same standards as before this ruling, but they they won’t have to go through the entire approval process for each test before launch. However, if a company makes false claims they will be subject to FDA sanctions.
This has been coming down the pipeline for a while. Last November the FDA announced that it was working on a new pathway for consumer genomics.
"The FDA is taking steps to implement a novel regulatory approach for the regulation of [genetics home reference (GHR)] tests that applies proper oversight in a flexible, new way," FDA Commissioner Scott Gottlieb said in a statement in November. "It builds on the important lessons we learned from the FDA’s authorization of the first GHR and carrier screening tests sold directly to consumers.”
But in the past genomics companies have run into difficulties navigating FDA regulations. Notably, 23andMe the FDA ordered the company to immediately stop selling its testing services until it went through the de novo process. The company eventually landed a de novo close to three years later, which allowed them to sell direct-to-consumer kits.
“The special controls describe the testing that 23andMe conducted to demonstrate the performance of these tests and clarify agency expectations for developers of other GHRs,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an . “By establishing special controls and eventually, a premarket review exemption, the FDA can provide a streamlined, flexible approach for tests using similar technologies to enter the market while the agency continues to help ensure that they provide accurate and reproducible results.”
Amending the guidances
Last fall the FDA released a slew of new draft guidances. One of the most controversial, proposed to change the way that clinical decision support tools are regulated, so that instead of a CDS device being regulated based on risk it will depend on the on the degree of human involvement. Under the new draft guidance a CDS tool does not have to be regulated if a doctor can independently review and understand the basis of the software’s decision.
Experts have split into two camps. Some like healthcare lawyer Nathaniel Lacktman praised Gottlieb for loosening regulations and recognizing “the need not to over-regulate our industry.”
But others, like Thompson, who is also the CDS Coalition leader, say the draft would expand the scope of FDA regulations, and that it fails to take a risk-based approach, lumping in many low-risk programs already on the market.
In February the CDS Coalition sent a letter, penned by Thompson, to the FDA, voicing its concerns and recommending that the FDA exempt low risk CDS software.
“FDA’s approach would basically extend regulation to any software that offers insights that the user might not be expected to come up with on his or her own,” Thompson wrote in the letter. “FDA would thus end up regulating any software that does not simply do mundane calculations that users could do themselves.”
Also announced last December were updates to the medical software policy based on Congressional mandates in the 21st Century Cures Act. In the Cures Act guidance, the FDA listed four categories of devices that the FDA won’t regulate, which are the same as the ones in the law that was passed in 2016, and include software used for administrative purposes in a hospital; wellness software for “maintaining or encouraging a healthy lifestyle;” EHR software; and software for transferring, storing or displaying data.
While in place since 2016, it is important to note that included in the Cures Act is guidance about using real world data (RWD) and real world evidence (RWE) in healthcare decisions. Both RWD and RWE can now be used to support regulatory decision making.
“Over the past decades, the use of computers and other electronic tools to gather and store huge amounts of health-related data has been increasing,” the . “This data holds potential to allow us to better design and conduct clinical trials in the health care setting to answer questions previously though infeasible. In addition, with the development of sophisticated, new analytical capabilities, we are better able to analyze these data and apply the results of our analyses to medical product development and approval.”
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