27/28 April 2021
CDRH, the FDA department responsible, inter alia, for the regulation of medical devices, published a new draft guidance in mid-December 2012. The Guidance ("Design Considerations for Devices Intended for Home Use") aims at assisting manufacturers in developing and designing home use medical devices. By applying this Guidance, especially the incorrect use of the products is to be prevented or at least minimised.
The draft consists of 22 pages subdivided in 10 chapters:
With reference to the GMP rules on medical devices (21 CFR 820, QSR) the chapter "Background" refers explicitly to the design requirements according to 21 CFR 820.30. The development of medical devices is to be assisted by a risk management plan identifying, estimating and evaluating potential hazards and risks of the new medical device, describing risk control and monitoring of the controls. Software is explicitly mentioned as potential risk, too.
The Chapter "Device Considerations" also addresses the topic calibration. If possible, home use medical devices should be designed without the need for calibration. Should a calibration be necessary nevertheless, it should be carried out according to the state of art and it should naturally be traceable.
Conclusions: the draft guidance on "Design Considerations for Devices Intended for Home Use" especially refers to design aspects of medical devices intended for home use, but it contains nevertheless valuable information for the manufacturers of other medical devices. This is also mentioned in the draft itself. The draft refers to a number of further guidances which makes it rather complex. You can comment the draft guidance until mid-March.
Please also see the draft guidance "Design Considerations for Devices Intended for Home Use".