FDA / EU MDR / Regulatory News
EU postpones application of the Medical Devices Regulation to prioritize the fight against coronavirus
This decision postpones, for exceptional reasons in the current context, the application of the Medical Device Regulation by one year – until 26 May 2021
This proposal will not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation (IVDR) and Eudamed (database which will be used to monitor the safety and performance of devices and is part of the EU’s MDR), which become applicable from 26 May 2022
The FDA guidance facilitates expanded use of remote monitoring devices during COVID-19 pandemic.
“FDA believes the policy set forth in this guidance will help address these urgent public health concerns by helping to expand the availability and capability of remote patient monitoring devices“
During the period the guideline is effective, the FDA will not object “to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring during the declared public health emergency without prior submission of a premarket notification.”
The enforcement policy described in the guidance applies to the following non-invasive remote monitoring devices:
| Device Type |
Classification Regulation |
Product Code |
| Clinical electronic thermometer |
21 CFR 880.2910 |
FLL |
| Electrocardiograph (ECG) |
21 CFR 870.2340 |
DPS |
| Cardiac monitor |
21 CFR 870.2300 |
DRT, MWI, MSX, PLB |
| Electrocardiograph software for over-the-counter use |
21 CFR 870.2345 |
QDA |
| Pulse Oximetry (SpO2) |
21 CFR 870.2700 |
DQA |
| Non-invasive Blood Pressure (NIBP) |
21 CFR 870.1130 |
DXN |
| Respiratory Rate/Breathing Frequency |
21 CFR 868.2375 |
BZQ |
| Electronic Stethoscope |
21 CFR 870.1875 |
DQD |
FDA stood up a new emergency program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.
By redeploying staff, the FDA thinks it can respond to COVID-19-related requests and review protocols within 24 hours of receipt as political pressure ramps up to speed along new therapies and vaccines.
FDA is prioritizing interactions “based on a product’s scientific merits, stage of development and identification as a possible priority product.”
Cybersecurity
FBI and “Zoom-bombing”
The Federal Bureau of Investigation (FBI) has released an article on defending against video-teleconferencing (VTC) hijacking (referred to as “Zoom-bombing” when attacks are to the Zoom VTC platform).
As individuals continue the transition to online lessons and meetings, the FBI recommends exercising due diligence and caution in your cybersecurity efforts. The following steps can be taken to mitigate teleconference hijacking threats:
- Do not make meetings or classrooms public. In Zoom, there are two options to make a meeting private: require a meeting password or use the waiting room feature and control the admittance of guests.
- Do not share a link to a teleconference or classroom on an unrestricted publicly available social media post. Provide the link directly to specific people.
- Manage screensharing options. In Zoom, change screensharing to “Host Only.”
- Ensure users are using the updated version of remote access/meeting applications. In January 2020, Zoom updated their software. In their security update, the teleconference software provider added passwords by default for meetings and disabled the ability to randomly scan for meetings to join.
- Lastly, ensure that your organization’s telework policy or guide addresses requirements for physical and information security.
