Memorandum

FDA Clears Tandem’s Control-IQ as “Interoperable Automated Glycemic Controller” (iController), Creating 510(k) Path for AID Algorithms; US Launch By “End of January 2020” – December 13, 2019

Executive Highlights

  • In major news, the FDA and Tandem announced the de novo authorization of Control-IQ as the first-ever “interoperable automated glycemic controller” (iController), creating a lower-risk class II (510(k)) pathway for interoperable AID algorithms – special controls posted here.­ Impressively, interoperable frameworks are now in place for all three components of an AID system (iCGM, ACE pump, and iController) – enabling faster innovation, less regulatory burden, and more component flexibility and patient choice.

  • Tandem will launch Control-IQ by the end of next month (January) – including new pumps with the advanced hybrid closed loop algorithm and a free, at-home software update for current t:slim X2 users. As expected, Control-IQ is cleared for 14 years and up with the Dexcom G6 CGM. Users will need a new prescription and must complete an online training module to receive the update.

    • Control-IQ will be the second AID system to the US market and the first with a no-fingersticks CGM (Dexcom G6), automated correction boluses, a free home software update, and embedded Bluetooth. Patient and provider excitement for Control-IQ has been categorized as “off the charts,” especially following extremely positive pivotal data at ADA and published in NEJM. This product will be a huge driver for Tandem in 2020; for delivering a simpler, next-gen user experience of AID; and expanding the entire category.

    • Remarkably, Tandem has already updated its t:simulator app (App Store; Google Play) and website with Control-IQ. The t:simulator app allows users to get a look at the user interface for Control-IQ on a simulated pump screen on their phone (see pictures below).

  • Tandem submitted Control-IQ to the FDA in ~July, a remarkably fast ~six-month FDA review for a brand-new regulatory classification. We saw a six-month review time for Dexcom’s G6 to create the new iCGM pathway (March 2018) and a four-month review for the t:slim X2 to create the ACE Pump path (February 2019). With the new iController classification, the FDA has created a set of special controls criteria, which include requirements “related to reliability, device interoperability, cybersecurity, and clinical relevance.” Most notably, the special controls don’t specify any performance standard (like iCGM) or study size, instead requiring clinical data to demonstrate performance “as appropriate, as determined by the FDA.” The controls also note that iControllers are cleared for use specifically with iCGM and ACE pumps.

    • With all the components of an interoperable AID ecosystem in place and now regulated individually, the FDA has radically changed the regulatory playing field for getting closed-loop systems to market and innovating. For example, if Dexcom’s G7 is cleared as an iCGM, Control-IQ will be able to upgrade from G6 to G7 quickly – avoiding a whole new study and the slow PMA (class III) system path of the past. If Tandem gets its next-gen t:sport cleared as an ACE Pump, it can seamlessly integrate Control-IQ. We expect other players (e.g., Abbott, Insulet, Medtronic, Tidepool) will take advantage of this new algorithm pathway, given the clear advantages for iterating components.

    • The FDA press release headline places notable emphasis on interoperability and patient choice: “FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system.”

  • It has been a remarkable year for Tandem: as of January, Control-IQ was still in the NIH-funded pivotal study; closing the year, Tandem has taken it all the way to clearance and created two entirely new pathways! Tandem received interoperable ACE pump clearance for the t:slim X2 in February, discovered and successfully patched a software bug in March and April, read out Control-IQ pivotal results (with no drop-outs!) at ADA 2019, published those results in the New England Journal of Medicine, and pushed Control-IQ through the FDA in a de novo submission. Wow!

  • See below for all the details on Control-IQ, the launch, the new regulatory pathway, implications for Tandem, implications for AID and competition, product pictures, what’s next for Control-IQ, and our questions.

    iController Definition, Control-IQ Indication, and Pictures

    In the FDA letter to Tandem, the FDA defines the new iController classification.

    • Interoperable automated glycemic controller. An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

    Tandem’s press release includes the indications for use for t:slim X2 and Control-IQ:

    • Control-IQ: Control-IQ technology is intended for use with a compatible integrated continuous glucose monitor (iCGM, sold separately) and ACE pump to automatically increase, decrease, and suspend delivery of basal insulin based on CGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 14 years of age and greater. Control-IQ technology is intended for single patient use. Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.

    • t:slim X2 insulin pump: The t:slim X2 insulin pump with interoperable technology is an alternate controller enabled (ACE) pump that is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in individuals 6 years of age and greater. The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use with NovoLog or Humalog U-100 insulin.

    The pictures below are taken from Tandem’s t:simulator app (App Store; Google Play), which has just been updated to include simulations of Control-IQ. The interface looks outstanding and does a much better job than the MiniMed 670G at flagging for the user what has been happening. The diamond on the left side and the indicator on the top right indicates boluses, automated basal actions, and shut-offs. Insulin-on-board also includes both automated basal and bolus insulin, key for users making decisions. (By contrast, the 670G does not include automated basal in IOB, and we think this is a serious drawback for fully optimizing Time in Range.)

    Launch Timing & Product Details

    Control-IQ is expected to “be available by the end of January 2020” as a free at-home software update for all in-warranty Tandem t:slim X2 users ages 14+ in the US, with new pumps with Control-IQ shipping in the same timeframe. Tandem submitted Control-IQ to the FDA in ~July, marking ~six-month review timeline – that was perhaps longer than initially expected (the MiniMed 670G was approved in three months under a PMA, and the Dexcom G6 and Tandem t:slim X2 pump were already FDA-cleared), though the creation of a brand new regulatory pathway likely contributed to a longer review process. We saw a six-month review time as Dexcom G6, which similarly created a brand-new iCGM pathway. The “January 2020” launch timing comes just outside of previous expectations to launch in “4Q19,” but with product clearance coming so late in the year, we are glad to see Tandem being patient and ensuring a smooth rollout – there is much more to lose from rushing to market vs. waiting one month. Per Tandem’s 3Q19 remarks, the company will “take a few weeks” to educate providers on features and functionality, before shipping out pumps with Control-IQ to new users and rolling out the software update. At DiabetesMine Innovation Summit last month, Tandem’s Garrett Marin gave a walkthrough of the planned five-step update process – it’s unclear whether the FDA required any sorts of changes to this process before clearance. Eligible users will receive an email announcing availability of Control-IQ, which will take users to an “online portal” to request a prescription. According to Tandem’s press release, this email will come “in the coming days.” When Tandem receives the signed prescription, users will be sent an online training. After completing the training and passing a “comprehensive quiz,” a unique code will be sent to users to download Control-IQ. Basal-IQ will remain available for users.

    Control-IQ will be the second automated insulin delivery (AID) system to market after the MiniMed 670G (US launch in June 2017) and the first with a no-calibration CGM (Dexcom G6), automatic correction boluses, free at-home updates, and Bluetooth built-in. The Control-IQ algorithm, licensed from Dexcom-owned TypeZero, uses CGM readings, insulin-on-board, programmed pump settings (e.g., basal rate, insulin-to-carb ratio, and insulin correction factor), and “other variables” to predict blood glucose values 30 minutes into the future. When the predicted insulin value is between 112.5-160 mg/dl, the algorithm maintains the “active Personal Profile”; in other words, insulin is delivered as programmed by the user. When glucose is predicted to be between 70 and 112.5 mg/dl in 30 minutes, the basal insulin delivery is decreased and if glucose is predicted to be below 70 mg/dl in 30 minutes, basal insulin delivery is shut off. Similarly, basal insulin is increased when blood glucose is predicted to be between 160-180 mg/dl in 30 minutes and a correction bolus is delivered when glucose is predicted to be above 180 mg/dl in 30 minutes. These automated correction boluses are calculated as approximately 60% of a correction bolus needed to reach a target of 110 mg/dl. When Sleep Activity is activated (either by a programmed sleep schedule or manually enabled by the user), the adjustment ranges are lowered and narrows in order to achieve a tighter 112.5-120 mg/dl by the morning. Conversely, when Exercise Activity is enabled, the ranges are raised to achieve glucose values between 140 and 160 mg/dl. The chart below summarizes the algorithm very nicely!

    • Control-IQ’s extremely positive pivotal data read-out at ADA 2019 and was subsequently published in NEJM. The pivotal met all primary and secondary endpoints – Time-in-range (70-180 mg/dl) was 2.6 hours per day better with Control-IQ – 70% vs. 59% (p<0.0001) – with most of the benefit coming from less time >180 mg/dl (-2.4 hours/day). Control-IQ had a 0.33% advantage in A1c at six months (baseline: 7.4%; p=0.0014), and mean CGM was 13 mg/dl lower with Control-IQ by the end of the study (156 vs. 170 mg/dl; p<0.001). All 168 participants completed the randomized study, and Control-IQ users spent a remarkable 92% (!) of the full six months with closed loop active – a stunning result. Lastly, Control-IQ achieved near-perfect scores on a technology acceptance questionnaire: ease of use was 4.7/5, usefulness was 4.6/5, trust was 4.5/5, and desire to continue using was an impressive 4.8/5 – an encouraging sign of the system’s simplicity (no modes to juggle), the no fingersticks G6, and limited alarms.

    New 510(k) Regulatory Pathway: “Interoperable Automated Glycemic Controller” and Special Controls

    In industry-changing news, the FDA granted marketing authorization for Control-IQ under a new “interoperable automated glycemic controller” (previously referred to as “iController”) classification. Through a de novo submission for Control-IQ, the FDA has created a new pathway for interoperable automated insulin delivery algorithms, down-regulating them from a high-risk class III (PMA) to a lower-risk class II device. Future iControllers will be able to submit 510(k)s to the FDA and claim Control-IQ as the “substantially equivalent” predicate device.

    Special controls for the iController classification are outlined in the FDA’s letter to Tandem (pasted in the appendix below). The controls outline the reliability, device interoperability, cybersecurity, and clinical relevance requirements for an iController, but importantly, do not specify any performance standard (like iCGM) or require studies of a certain size/type. There seems to be a lot of flexibility to work with the FDA, which we take as an excellent sign for the entire field. The most notable special controls relate to:

    • Clinical data is required to demonstrate clinical performance of the device “as appropriate, as determined by the FDA”

    • Appropriate measures must be in place when connection with other devices is interrupted, lost, and re-stablished after an interruption

    • Critical events (e.g., commands, malfunctions, alarms, and connectivity) must be recorded to allow for auditing of communications between digitally connected devices

    • Device can only receive glucose data from iCGM and only send drug delivery commands to ACE pumps

    The FDA press release headline places notable emphasis on interoperability and patient choice: “FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system.” The iController was the third and final piece necessary to build out an AID system that separately regulates the individual components (i.e., iCGM, ACE pump, and iController) and allows users to stitch them together (provided the companies have a relationship and the devices have the appropriate interoperable indication). Incredibly, these three classifications were all created in the past ~20 months (Dexcom G6 was cleared as an iCGM in March 2018) and all under the lower-risk class II pathway. This new interoperable AID framework will be a huge improvement over the previous class III PMA submissions required for every combination of AID components, reducing regulatory burden, reducing the entry barrier for manufacturers, allowing faster iteration, and enabling more patient choice.

    Getting the new iController classification down-regulated as a class II device is a huge win, as it is arguably more nuanced than iCGM accuracy requirements or ACE pump communication requirements. Still, just a few months ago in June, FDA’s Dr. Alain Silk suggested it was coming, saying, “We do think that a class II, 510(k) pathway with Special Controls may be a way to get to regulation of the software controller as a medical device.”

    • Many next-generation AID systems (e.g., Tidepool Loop, Insulet Omnipod Horizon, Tandem t:sport) are expected to have direct smartphone control. Who will be able to launch this first? Will algorithms with smartphone control still be considered class II devices?

    • For an excellent FDA review of the interoperable AID category and the advantages, see Dr. Alain Silk’s presentation from ADA 2019. The picture below illustrates the aim pretty well for a simpler pump-CGM integration – regulating the components separately (bottom) reduces the regulatory hassle relative to the PMA path (top).

     

    Implications for Tandem

    • It has been a remarkable year for Tandem: as of January, Control-IQ was still in its pivotal study; Tandem has taken it all the way to product approval and created two entirely new regulatory pathways. Tandem received ACE pump clearance for t:slim X2 in February, discovered and successfully patched a software bug in March and April, read out Control-IQ pivotal results (with no drop-outs!) at ADA 2019, published those results in the New England Journal of Medicine, and pushed Control-IQ through the FDA in a de novo submission. Wow!

    • Control-IQ will launch as the first commercial hybrid closed loop system with a no fingersticks CGM (Dexcom G6), automatic correction boluses, and embedded Bluetooth. Tandem is also still the only company offering free, in-warranty software updates that can be done at home. This system is a significant advantage over the currently available MiniMed 670G, and Insulet’s Omnipod Horizon is slated for a 2H20 launch. Tidepool Loop’s timing is unclear, though the creation of this new category could help it get to market quickly. See our updated AID Competitive Landscape here.

    • With a brand new, lower-risk regulatory pathway, Tandem’s follow-on products should get to market faster – e.g., the launch of t:sport next year. Competitors will have to play catch up to utilize the 510(k) pathway – e.g., Insulet added ACE Pump labeling seven months after Tandem, while not a single company has added iCGM labeling (FreeStyle Libre 2 is close).

    • The Control-IQ algorithm is licensed from TypeZero, which is now owned by Dexcom. We wonder if other pump and CGM companies will be able to access the interoperable control algorithm, provided the business relationship is in place. For example, could Insulet use this algorithm as a separate product from its own Horizon system and Tidepool Loop, integrating it with the Omnipod Dash ACE Pump and G6 iCGM? Could Lilly and Beta Bionics integrate Control-IQ with the G6 iCGM, assuming they obtain ACE Pump labeling? Theoretically, any ACE Pump company partnered with Dexcom could integrate Control-IQ without having to run a pivotal trial; however, we’re not positive about that, as it could depend on the business relationship and IP around Control-IQ between Tandem and Dexcom. And how smart of Dexcom to buy this algorithm!

      • More ambitiously, we wonder if the new Abbott FreeStyle Libre-Tandem pump partnership could use Control-IQ? That seems the most unlikely, but we’ll be eager to see what happens. ( is currently the only other ACE pump, aside from t:slim X2)? 

    Implications for Automated Insulin Delivery and Competition

    With the final piece of the FDA’s interoperable vision for AID components, the doors have been blown open for faster component iteration and more customizability for patients. Based on the special controls released today, becoming an iController does not seem onerous; presumably it will become the de facto standard for new AID algorithm submissions. We’ve already seen iCGM become a sort-of standard for CGM companies, though Dexcom G6 and G6 Pro remain the only currently cleared iCGMs; Abbott and Senseonics seem poised to get iCGM clearance within the next six months (for FreeStyle Libre 2 and Eversense 90-Day, respectively), and Medtronic is currently in its pivotal study with the Zeus CGM. With recent ACE pump labeling for Omnipod Dash, Medtronic is now the only insulin pump company in the US without the ACE designation – the company announced it would work on a Bluetooth ACE pump back in June. MiniMed 780G, Tidepool Loop, and Omnipod Horizon could all be submitted to the FDA in the next 12 months – how many of these will take advantage of the newly created algorithm pathway? See our freshly updated AID landscape.

    Even with the fully interoperable framework now in place, formal company agreements are still needed to share device data and actually form an AID system. As Dexcom G6 + Tandem t:slim X2 + Control-IQ will be the first interoperable AID system, we will be watching closely on how the two companies handle supplies and customer service. As Dexcom CEO Kevin Sayer shared in our interview earlier today, interoperability in diabetes devices will never be truly mix-and-match like we see in consumer electronics (e.g., Sony Bluetooth headphones can work with Apple and Samsung smartphones without any formal company agreements or submission to a regulator). Still, the regulatory and product innovation advantages of moving to a class II, 510(k), component-level regulation are still hugely attractive to manufacturers.

    • Ultimately, it’s unclear how patients will view closed, single-company systems (e.g., MiniMed 670G) vs. interoperable-component systems (e.g., Tandem Control-IQ + Dexcom G6) systems. The availability of both frameworks is a win for patient choice and competition. In a closed approach like Medtronic, customers have the advantage of relying on a single manufacturer for all their needs. Given the products are all developed at the same organization, they may also have more reliable or optimized integration. The downside to a closed framework is a company like Medtronic must excel at all three AID components; in Medtronic’s case, this has meant lagging behind on CGM and algorithm simplicity. An interoperable framework allows manufacturers to specialize in one or two specific parts of a system, potentially creating more compelling individual offerings (e.g., Dexcom G6 is a more compelling offering than Medtronic’s Guardian Sensor 3), and it creates more room for patients’ particular preferences. To the extent we see multiple CGM companies integrating with multiple pump companies, it may also protect patients against payer dynamics – e.g., Dexcom and Abbott and Senseonics could integrate with various pump companies. However, these components must all work reliably together and have clear protocols for assigning responsibility when issues arise.

    What’s Next for Control-IQ?

    Tandem is expected to launch the t:connect smartphone app concurrently with Control-IQ, though we didn’t hear any updates on that today. The secondary display app will allow patients to upload their pump data and Dexcom G6 data to the t:connect web platform wirelessly, the first no-cable uploader for a pump in the US. (From what we can tell, Omnipod Dash still needs to be plugged in to a computer to upload to Glooko, though it will add this capability over time.) The t:connect app mirrors pump information, including Dexcom CGM trend, insulin on board, recent boluses, and basal information.

    • The pediatric pivotal for Control-IQ (ClinicalTrials.gov) is on track for FDA submission in 1Q20 for participants 6-14 years old. As of 2Q19, management thought pediatric approval for Control-IQ could come before summer 2020, where diabetes camps will offer a “significant educational and market opportunity.” Notably, the Control-IQ product page currently has an explicit boxed warning that Control-IQ “should not be used by anyone under the age of six years old.” Since the pediatric indication is the same algorithm (to our knowledge), it should be a 510(k) filing claiming substantial equivalence to today’s submission.

    • International launch plans for Control-IQ will likely be discussed on Tandem’s 4Q20 call early next year. Of course, Control-IQ will be limited to countries where both t:slim X2 and Dexcom G6 are available.

    Close Concerns’ Questions

    • How much will all the new class II, 510(k) pathway reduce regulatory burden and speed innovation in automated insulin delivery?

    • What level of change to an iController would require an entirely new clinical study?

    • What will user uptake look like for Control-IQ? How fast will current users upgrade in 2020? Will Control-IQ accelerate technology uptake in MDI/fingerstick users?

    • How is the FDA defining “substantial equivalence” for controllers? Will Control-IQ or other iControllers placed on a smartphone still be a 510(k) submission?

    • Will other ACE pump manufacturers who want to use Control-IQ work with Dexcom? Or does the Tandem-Dexcom relationship prevent this? What about other CGM manufacturers that want to integrate with Tandem’s Control-IQ – e.g., could Abbott’s FreeStyle Libre 2 iCGM use Control-IQ, or will Abbott need to find its own control algorithm?

    • How will patients view closed vs. interoperable AID systems? How much a competitive advantage will iController be for Control-IQ? How long will it take other companies to get iController status?

    • How will payers view closed vs. interoperable AID systems?

    • How will Tandem and Dexcom handle customer service and other responsibilities related to Control-IQ? Will this be scalable into larger numbers of users (e.g., tens or hundreds of thousands)? How difficult will it be for patients to navigate multiple suppliers?

    • Will these next-gen AID user experiences drive significantly larger uptake of pumps and CGM? Will the uptake be rapid (1-3 years) or gradual (5+ years)? When we will we see the vast majority of type 1s on AID? For how many years will cost remain a gating factor?

    • How usable is Control-IQ for HCPs? How long will it take Tandem to train HCPs on its use?

    Additional Control-IQ Pictures

    Appendix: “Interoperable Automated Glycemic Controller” (iController) Special Controls

    Pasted from the FDA letter to Tandem

    1. Design verification and validation must include:
      1. An appropriate, as determined by FDA, clinical implementation strategy, including data demonstrating appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
        1. The clinical data must be representative of the performance of the device in the intended use population and in clinically relevant use scenarios and sufficient to demonstrate appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
        2. For devices indicated for use with multiple therapeutic agents for the same therapeutic effect (e.g., more than one type of insulin), data demonstrating performance with each product or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed.
        3. When determined to be necessary by FDA, the strategy must include postmarket data collection to confirm safe real-world use and monitor for rare adverse events.
      2. Results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
      3. A detailed and appropriate, as determined by FDA, strategy to ensure secure and reliable means of data transmission with other intended connected devices.
      4. Specifications that are appropriate, as determined by FDA, for connected devices that shall be eligible to provide input to (e.g., specification of glucose sensor performance) or accept commands from (e.g., specifications for drug infusion pump performance) the controller, and a detailed strategy for ensuring that connected devices meet these specifications.
      5. Specifications for devices responsible for hosting the controller, and a detailed and appropriate, as determined by FDA, strategy for ensuring that the specifications are met by the hosting devices.
      6. Documentation demonstrating that appropriate, as determined by FDA, measures are in place (e.g., validated device design features) to ensure that safe therapy is maintained when communication with digitally connected devices is interrupted, lost, or re-established after an interruption. Validation testing results must demonstrate that critical events that occur during a loss of communications (e.g., commands, device malfunctions, occlusions, etc.) are handled and logged appropriately during and after the interruption to maintain patient safety.
      7. A detailed plan and procedure for assigning post-market responsibilities including adverse event reporting, complaint handling, and investigations with the manufacturers of devices that are digitally connected to the controller.
    2. Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following:
      1. Risk control measures to address device system hazards;
      2. Design decisions related to how the risk control measures impact essential performance; and
      3. A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design.
    1. The device shall include appropriate, as determined by FDA, and validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
      1. Secure authentication (pairing) to connected devices;
      2. Secure, accurate, and reliable means of data transmission between the controller and connected devices;
      3. Sharing of necessary state information between the controller and any connected devices (e.g., battery level, reservoir level, sensor use life, pump status, error conditions);
      4. Ensuring that the controller continues to operate safely when data is received in a manner outside the bounds of the parameters specified;
      5. A detailed process and procedures for sharing the controller’s interface specification with connected devices and for validating the correct implementation of that protocol; and
      6. A mechanism for updating the controller software, including any software that is required for operation of the controller in a manner that ensures its safety and performance.
    2. The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices, and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the controller must, at a minimum, include:
      1. Commands issued by the controller, and associated confirmations the controller receives from digitally connected devices;
      2. Malfunctions of the controller and malfunctions reported to the controller by digitally connected devices (e.g., infusion pump occlusion, glucose sensor shut down);
      3. Alarms and alerts and associated acknowledgements from the controller as well as those reported to the controller by digitally connected devices; and
      4. Connectivity events (e.g., establishment or loss of communications).
    3. The device must only receive glucose input from devices cleared under 21 CFR 862.1355 (Integrated continuous glucose monitoring system), unless FDA determines an alternate type of glucose input device is designed appropriately to allow the controller to meet the special controls contained within this section.
    4. The device must only command drug delivery from devices cleared under 21 CFR 880.5730 (Alternate controller enabled infusion pump), unless FDA determines an alternate type of drug infusion pump device is designed appropriately to allow the controller to meet the special controls contained within this section.
    5. An appropriate, as determined by FDA, training plan must be established for users and healthcare providers to assure the safety and performance of the device when used. This may include, but not be limited to, training on device contraindications, situations in which the device should not be used, notable differences in device functionality or features compared to similar alternative therapies, and information to help prescribers identify suitable candidate patients, as applicable.
    6. The labeling required under 21 CFR 809.10(b) must include:
      1. A contraindication for use in pediatric populations except to the extent clinical performance data or other available information demonstrates that it can be safely used in pediatric populations in whole or in part.
      2. A prominent statement identifying any populations for which use of this device has been determined to be unsafe.
      3. A prominent statement identifying by name the therapeutic agents that are compatible with the controller, including their identity and concentration, as appropriate.
      4. The identity of those digitally connected devices with which the controller can be used, including descriptions of the specific system configurations that can be used, per the detailed strategy submitted under paragraph (1)(iii).
      5. A comprehensive description of representative clinical performance in the hands of the intended user, including information specific to use in the pediatric use population, as appropriate.
      6. A comprehensive description of safety of the device, including, for example, the incidence of severe hypoglycemia, diabetic ketoacidosis, and other relevant adverse events observed in a study conducted to satisfy paragraph (1)(i).
      7. For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
      8. For any controller with hardware components intended for multiple patient reuse, instructions for safely reprocessing the hardware components between uses.

     

    --by Albert Cai, Adam Brown, and Kelly Close