The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued guidance documents dedicated to certain medical devices becoming significantly important in the current environment: first guidance covers the infusion pumps and accessories thereto while the scope of the second document describes regulatory aspects relating to clinical electronic thermometers. Both documents are intended to assist medical device manufacturers facing an increase in demand due to the outbreak of the coronavirus disease (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus”. The outbreak of the disease led to the increasing number of patients requiring treatment of respiratory illnesses and complications associated thereto, resulting in surging demand on the appropriate respiratory medical devices. To ensure the availability of the aforementioned devices to the healthcare institutions and avoid potential shortages caused by insufficiency of the devices allowed to be marketed, the Agency implemented certain regulatory flexibilities creating a favourable legal framework for medical device manufacturers focused at this particular sphere, allowing them to use accelerated and simplified procedures requiring less time to complete all regulatory steps and place critical devices on the market.
It is important to mention that the policies introduced by the guidance documents are to be implemented immediately without prior public consultations. The Agency applies this accelerated procedure due to the public health emergency announced in the US earlier in March. At the same time, industry representatives still could provide their feedback and comments.
The Agency also emphasizes that the special measures introduced by the polices are temporary. Both documents would remain effective only during the public health emergency, and the general rules and requirements should be applied upon its cancellation.
FDA Approach to Infusion Pumps and Accessories
The scope of the first document published by the FDA covers infusion pumps and accessories thereto intended for treating patients that need continuous infusion therapy. In particular, the document establishes rules and requirements for the following types of medical devices:
- Infusion Pump (Product Code – FRN),
- Patient-controlled analgesia Infusion Pump (MEA),
- Infusion Pump Accessories (MRZ),
- Infusion Safety Management Software (PHC).
Thus, the scope of the document covers, inter alia, syringe infusion pumps, ambulatory infusion pump devices, and large volume parental infusion devices.
During the pandemic, a lot of patients require an infusion of medicines or other liquids. This resulted in increasing unmet demand on the devices that could be used for this purpose. In general, the Agency recommends to use medical devices that have already been approved and passed all conformity assessment procedures, or the devices subject to the Emergency Use Authorization (EUA) – a special regulatory framework used by medical device manufacturers placing critical supply devices on the market. At the same time, the Agency recognizes that the number of FDA-cleared devices is not sufficient to meet the demand existing in the current environment. To ensure the availability of the devices that are of significant importance, the Agency announced that it would not object to certain changes and modifications to the devices made without prior approval. Thus, medical device manufacturers are allowed to make changes to the design of their medical devices, the materials used, the software and also to the indications, without submitting a 510(k) premarket notification. This amendment is being implemented to provide medical device manufacturers with additional flexibility.
The document also provides examples of changes falling within the scope of the new temporary rules. In particular, the manufacturer could:
- Utilize the infusion pump motors provided by another supplier, or
- Establish compatibility with the accessories manufactured by another supplier.
Thus, the Agency introduces these measures to assist medical device manufacturers in increasing their production capacity to be able to meet the demand they faced. Under the new regulatory framework temporarily introduced by the FDA, the manufacturers are allowed to make limited modifications to medical devices without submitting a premarket notification, providing that such modifications do not create a significant risk to the public health. According to the document, such changes or improvements could include:
- Implementation of the remote monitoring system allowing to maintain remote control to reduce contacts between patients and healthcare professionals. The remote control should include a full scope of functions, such as changing parameters or monitoring alarms).
- Changes to the hardware and/or software of the device necessary to implement the remote monitoring functions, and also the changes needed to implement centralized remote control and monitoring.
- Establishing wireless connections.
- Extension of the use of infusion pumps to categories of patients and/or environments of use other than they are initially intended to.
- Modifications made to the device already approved by the FDA to implement additional compatibility with the accessories produced by another manufacturer.
Due to the risks associated with the COVID-19 outbreak, the Agency additionally emphasized the importance of using novel technologies to reduce contacts between patients and healthcare professionals to mitigate risks of infecting. Medical device manufacturers are advised to use wireless connection technologies providing that such connections and all the information transferred would be secured – the manufacturer shall ensure the highest level of protection against any unauthorized third-party intervention in operations of the device or disclosure of the patient`s information collected by the remote monitoring system and transferred using the wireless connection.
Regulatory Approach to Electronic Thermometers
The second document issued by the FDA is dedicated to the clinical electronic thermometers (Product Code: FLL), considered Class II medical devices. It is also important to mention that the scope of the document covers both contact and non-contact devices.
During the pandemic, clinical electronic thermometers are widely used to measure body temperature. Thus, the demand for the devices of this type has also increased significantly. According to the general rule, manufacturers intended to supply electronic thermometers to the US market should submit a 510(k) premarket notification applying for the FDA approval, and also to fulfill all applicable requirements related to the post-marketing surveillance. At the same time, the FDA recognizes the lack of such devices existing nowadays. To address this issue, the Agency implements certain flexibilities to the regulatory procedures devices in question should be subject to. In particular, the Agency announced that it would not object making available on the market the devices of the aforementioned type that have not been duly cleared by the FDA. This decision is based on the position that non-FDA-cleared clinical electronic thermometers could not create additional risk to public health. In accordance with the document, the risk would not be significant in case if:
- Thermometers comply with the requirements set forth by the applicable harmonized international standard (ISO 13485:2016).
- The device in question has been already approved and allowed to be marketed in another jurisdiction or its performance complies with applicable harmonized international standards.
- The label of the device contains detailed information on the performance of the device, the methods used to determine the temperatures, identified potential risks associated with the use of the device, and also the instructions and recommendations on cleaning and reprocessing.
It is also important to mention that irrespectively of the type of the device, the FDA requires the manufacturer to indicate explicitly in the labeling that some of the modifications to the device were not approved by the Agency. In particular, unapproved functions and features should be clearly distinguished from approved ones.
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