The US FDA released a new guidance document communicating a new policy intended to expand the use a hospital based vital signs equipment to include home use. This policy changes is in response to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. You can download the guidance by clicking this link: Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
The enforcement policy described in this guidance applies only to the following non-invasive remote monitoring devices that measure or detect common physiological parameters and that are used to support patient monitoring during the COVID-19 public health emergency:
- Clinical electronic thermometer 21 CFR 880.2910
- Electrocardiograph (ECG) 21 CFR 870.2340
- Cardiac monitor 21 CFR 870.2300
- Electrocardiograph software for over-the- counter use 21 CFR 870.2345
- Pulse Oximetry (SpO2) 21 CFR 870.2700
- Non-invasive Blood Pressure (NIBP) 21 CFR 870.1130
- Respiratory Rate/Breathing Frequency 21 CFR 868.2375
- Electronic Stethoscope 21 CFR 870.1875
FDA does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA- cleared non-invasive remote monitoring devices that are used to support patient monitoring (hereinafter referred to as “subject devices”) during the declared public health emergency.
For the duration of the public health emergency, FDA does not intend to object to modifications to the FDA-cleared indications, claims, or functionality of the subject devices without prior submission of a premarket notification where the modification does not create an undue risk in light of the public health emergency.
For the duration of the public health emergency, FDA does not intend to object to hardware or software architecture modifications to subject devices that allow for increased remote monitoring capability to support additional claims or indications without prior submission of a premarket notification, taking into account the considerations described above (in Section IV.A.) and where the modifications do not directly affect the physiological parameter measurement algorithms.
Examples of such modifications include:
- The inclusion of monitoring statements related to patients with COVID-19 or co-existing conditions (such as hypertension or heart failure)
- For subject devices previously cleared only for use in hospitals or other health care facilities, a change to the indications or claims regarding use in the home setting
- Hardware or software changes to allow for increased remote monitoring capability
Categories Discussed in this guidance:
- Modifications to FDA-cleared Indications, Claims, or Functionality
- Modifications to FDA-cleared Hardware or Software Intended to Increase Remote Monitoring Availability or Capability
- Clinical Decision Support Software for Monitoring related to COVID-19 and Co-existing Conditions
FDA reminders contained in this guidance:
- FDA recommends that the labeling for devices described above include the following elements, where these elements are not already required by regulation.
- FDA is making these labeling recommendations because it believes they will help users better understand the device modifications. (There are 5 items listed in the guidance for labeling)
- FDA recommends any such changes be designed, evaluated and validated in accordance with FDA recognized standards (a list of example standards is contained in the guidance)
- In addition, for any such changes, manufacturers should develop and implement appropriate cybersecurity controls to assure device cybersecurity and maintain device functionality and safety.
- Device manufacturers can use their pre-existing Quality System Tools including established “emergency release” mechanisms that have been use for so called “hot” fixes and cybersecurity releases
- Device Manufacturers can do as much in parallel as possible. For example, work on requirements, designs, coding, test procedures, user documentation/IFU in parallel. Eliminate normal delays due to multiple
sign-offs and put one person in charge of all approvals to expedite delivery. That person should be the most knowledgeable of the whole design and well versed in the new intended use.
- Device Manufacturers can establish a real time one on one post market relationship with clients who are using these updated devices. Waiting for standard post market data, through standard post market data channels is not going to be an effective choice, during this Apollo 13 type event. This needs to be and AGILE and Real Time activity.