A Look Inside the FDA’s Review Processes for Medical Devices was reported by Hope Warshaw for T1DExchange.org, 25 June 2021.
Ever wonder how your diabetes devices and drugs get approved by the US FDA? It often feels like a slow, black box without much logic. Well, here’s a quick tutorial on how the U.S. Food and Drug Administration (FDA) classifies, reviews and allows any and all medical devices to enter the U.S marketplace. Plus, catch up on how FDA has recently opened the door to integrated and interoperable diabetes devices.
Most of the work to review medical devices is conducted within the FDA’s Center for Diagnostics and Radiological Health, abbreviated CDRH. CDRH reviews medical devices through one of several pathways. The pathway CDRH uses for review is based on the level of control needed by the person operating the device to assure the safe and effective use.
Stated more succinctly: how much potential the device has to cause harm to the user.
- 510k-exempt: very low-risk devices. These do not require FDA review prior to being made available. Example: insulin pen clip that does not offer bolus doses decision support
- Class I: low-risk devices. Examples: bandages, nonelectric wheelchairs
- Class II: moderate-risk devices. Example: blood glucose monitors (BGM), older insulin pumps without Continuous Glucose Monitor (CGM) integration, smart insulin pens that can integrate with CGM, such as: Medtronic’s InPen and Bigfoot’s Unity System
- Class III: higher user risk. Example: insulin pumps that integrate with CGM and assist in minimizing hyperglycemia and hypoglycemia
When a manufacturer submits a Class I or II device to CDRH for review, they submit what is called a Premarket Notification, also know as a 510k. If the manufacturer receives a positive review of their Class I or II device, it receives “clearance.” The device is then known as “FDA-cleared.”
When a manufacturer submits a Class III device they submit a Premarket Approval Application, abbreviated as a PMA. Class III devices undergo a more rigorous review at CDRH. This determines reasonable assurance of safety and effectiveness. If the manufacturer receives a positive review of their Class III device, it receives “approval.” The device is then known as “FDA-approved.”
FDA Opens the Door for Innovation in Diabetes Care: Over the past few years FDA’s CDRH has, through several new authorizations, has opened the door to diabetes device innovation, which includes greater device integration and interoperability (see definition below).
For starters, in 2018 FDA cleared the first integrated CGM (iCGM). An iCGM is integrated with other compatible medical devices and electronic interfaces, such as automated insulin dosing systems, insulin pumps, BGM or other electronic devices used for diabetes management. With this authorization FDA initially cleared the Dexcom G6 iCGM.
FDA also began classifying the iCGM as a Class II device with this authorization. (Older CGM systems were classified as Class III devices and required use of FDA’s premarket approval pathway.)
Next, in late 2019, FDA authorized the Tandem Diabetes Care Control-IQ technology. With this authorization, FDA allowed, “substantially equivalent controller technologies…to go thru the 510k review process” (see above)
This authorization opened the door to the first interoperable, automated glycemic controller device that automatically adjusts insulin delivery by connecting to an alternate controller-enabled insulin pump (abbreviated ACE pump) and integrated continuous glucose monitor (iCGM) (defined above). The Tandem Diabetes Care t:slim X2 Control-IQ Technology device was reviewed through a new route called the De Novo premarket review pathway established to enable faster innovation, less regulatory burden, more component flexibility, and more device choices. The FDA defined new device categories with this new pathway, including an interoperable automated glycemic controller device (referred to as icontroller). The icontroller automatically adjusts insulin delivery by connecting to an ACE pump and the iCGM.
Lastly, one other addition. In early 2019 FDA set a fast-track process in place referred to as the Breakthrough Devices Program. This program provides priority review to help people gain access to breakthrough technologies faster. In the diabetes area, Medtronic received this designation in 2019 for its Personalized Closed Loop (PCL) insulin pump system.5 The update on the PCL straight from Medtronic is that the PCL will be more advanced than MiniMed 780G. PCL is a future pump system currently in feasibility trials. (The MiniMed 780G was submitted to FDA by Medtronic in April 2021 and is currently under review.)
These important and numerous changes are putting the pieces in place for so-called, “device interoperability.” This will introduce the ability to purchase different device components (based on the user’s device preferences), and not to have to purchase the complete system from just one manufacturer.
As explained by Brandon Arbiter, VP of Product and Business Development at Tidepool, “Diabetes is not a one-size-fits-all disease. When a person with diabetes can choose and connect the components that work best for them, they will get better outcomes, and that’s why interoperability is so important for us.”
Access To Personal Health Information Draws Data Security Concerns was reported by Hannah Nelson for EHRIntelligence.com, 30 June 2021. This is a particularly important topic to people living with Type 1 diabetes, in which their blood glucose and pump data may be shared with HCPs who pay for a license, but not directly to the patient. Should every patient be allowed access to their own data captured by devices that measure their biological information? WITHOUT A DOUBT? Should patients have to “purchase” access to their own data? I don’t think so … do you?
A survey, conducted by Propeller Insights on behalf of Axway in April 2021, gathered insights from a nationally representative sample of 1,017 Americans about their digital healthcare experiences and their perception of health data security and privacy. Overall, 60 percent of respondents said that they wanted more control over who has access to their personal health information. Additionally, 36 percent of patients reported that they do not believe their personal health data is safe from hackers and 27 percent said they are unsure if their data is secure.
Beginning on July 1, CMS will enforce its Interoperability and Patient Access final rule which requires payers and providers to break down the silos that prevent patient access to personal health information.
To comply with the interoperability and patient access final rule, many provider organizations are implementing application programming interfaces (APIs). “Patients have a right under HIPAA to access their health information,” CMS officials noted in a fact sheet. “We believe they also have a right to know their health information is exchanged in a way that ensures their privacy and security. We are working to balance these important issues in a way that empowers patients to be in charge of their healthcare.”
Nearly half of physician practices owned by hospitals, corporate entities was reported by Samantha Liss for Healthcaredive.com, 29 June 2021.
Nearly 70% of U.S. physicians are now employed by a hospital or a corporate entity, according to the latest report by Avalere for the Physicians Advocacy Institute, a coalition of state doctors’ groups. This is the first time the report included ownership by corporate entities outside of just hospitals. Hospitals and corporate entities, which include insurers or private equity groups, own nearly half of the physician practices in this country, according to the report released in June 2021 that examines the two-year period from 2019 through 2020. Independent physicians are becoming increasingly rare in the U.S., which should raise some alarms, according to the Physicians Advocacy Institute.
This latest analysis shows that just three in 10 of the nation’s physicians remain independent. More physicians left independent practice after the onset of the pandemic, according to the report. Of the 48,400 that became employed by either a hospital or corporate entity over the two-year period, 22,700, or about 47%, left after the pandemic started.
The advocacy group penned a letter to Congress, urging greater federal scrutiny with a plea for policies “to help protect the physician-patient relationship from undue corporate interference. This report shows a startling shift towards the corporatization of healthcare across the U.S., which if left unchecked, may result in an inappropriate incursion into the practice of medicine,” the group wrote.
Diet, T1D, and the Microbiome was written by Jenna Feeley for TheSugarScience.org, 30 April 2021.
Research continually shows that diet plays an integral role in modulating the microbiome. Because the microbiome has a profound impact on many systems within the body, monitoring and adjusting dietary habits to fit individual patient needs is central to maintaining health and wellbeing. This is even more important for those who are living with or are susceptible to autoimmune conditions, as the microbiome plays an important role in immune regulation.
Short Chain Fatty Acids Protect Against T1D: Lactate and butyrate, which are Short Chain Fatty Acids (SCFAs), seem to play a protective effect in T1D development. Decreased levels of lactate and butyrate producing bacteria have been linked to pancreatic beta cell autoimmunity. Bacteria metabolize nondigestible carbohydrates such as those found in fruits and vegetables in order to produce SCFAs. Therefore, it is important that T1D susceptible patients consume a diet high in nondigestible carbohydrates to ensure healthy levels of SCFAs.
Bacteroides & Beta Cell Autoimmunity: The Bacteroides species of bacteria are pathogenic and commonly found in clinical infections. Increased levels of Bacteroides species can lead to beta cell autoimmunity and a dysbiotic state that may leave patients susceptible to T1D development. Higher levels of Bacteroides have been observed in those who consume high levels of saturated fat and animal protein. Alternatively, the protein casein, a protein found in milk, was found to have a protective impact against beta cell autoimmunity in patients who are susceptible to T1D development. Lastly, a gluten free diet may protect against autoimmune disorder development by increasing the Akkermansia species and decreasing Bifidobacterium, Tannerella, and Barnesiella species.
Ketogenic Diet, the Microbiome, & T1D: Ketogenic diets have been utilized by T1D patients in order to tighten blood glucose control; decreased carbohydrate load helps to reduce insulin needs and blood glucose fluctuations. Ketogenic diets may also modulate the immune system by altering microbiome contents. In mice it was found that decreased levels of Bifidobacteria (from a ketogenic diet) leads to a reduction of Th17 cells which subsequently reduces immune activation. Therefore, decreasing the Bifidobacteria species through a ketogenic diet would be beneficial for T1D patients as it would decrease unnecessary immune activation.
The takeaway: The diet plays an important role in maintaining health; however, with our new understanding of the microbiome and its far-reaching effects on overall health, our diet may be impacting us more than we previously thought. For T1D patients, diet impacts both the immune system (i.e. autoimmune attack against beta cells) in addition to daily blood sugar management. It is therefore imperative that T1D patients find a way of eating that supports their individual needs and promotes overall health. This may also be applied to those who are susceptible to T1D development as balancing the microbiome could potentially protect against autoimmune diseases.
Read more: Diet, T1D, and the Microbiome