Section 3060(b) of the 21st Century Cures Act* requires a report to be published every two years that examines information available on any risks and benefits to health associated with the (non-device) software functions.
FDA organized its findings in three categories across the five software functions, which align to the requirements of the Cures Act:
There are five (non-device) software functions:
Many of the findings detailed in this report correspond to positive impacts on patient safety and health benefits related to use of the five software functions. FDA acknowledges, however, that given there is no requirement to report adverse events from non-device software, adverse events may be underrepresented in this report.
*Section 3060(a), titled “Clarifying Medical Software Regulation,” amended the FD&C Act to add section 520(o), which describes software functions that are excluded from the definition of device in 201(h) of the FD&C Act.
FDA has developed this draft guidance document to recommend information that should be provided in a premarket submissions (i.e., PMA, 510(k) etc.) to demonstrate electromagnetic compatibility (EMC) for electrically powered medical devices and medical devices with electrical or electronic functions.
FDA recommends that the medical device manufacturer provides a summary describing all voluntary consensus standards used to evaluate EMC (such as IEC 60601/80601 series of standards that apply to devices used in patient care settings, while the IEC 61010-1 series applies to devices used in laboratory settings). In addition, FDA recommends that EMC tests be performed using methods described in FDA-recognized consensus standards that are appropriate for the medical device. If the consensus standard(s) referenced in the submission are not recognized by FDA, sufficient justification should be provided regarding how the EMC testing performed adequately addresses EMC, based on the medical device’s functions, modes, indications for use, intended use, and intended use environments.
The IVDR establishes 4 risk classes D, C, B, and A, with D being the highest risk class and A the lowest and there are 7 classification rules:
|Rule||Device Intended Use (example)|
|Rule 1||To detect transmissible agents of a life-threatening disease where it is critical for patient management or where the disease has a high risk or suspected high risk of propagation|
|Rule 2||To be used for blood grouping or tissue typing for the purposes of transfusion or transplantation|
C or D
|Rule 3||To detect, screen and manage various infectious diseases including for example; detecting the presence of a sexually transmitted agent, pre-natal screening and management of patients suffering from a life-threatening condition.|
C or B
|Rule 5||General Laboratory Use|
|Rule 6||Devices not covered in Rules 1-5|
|Rule 7||Devices which are controls without a quantitative or qualitative assigned value|
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