emergo Archives - Medical Design Sourcing

Applying the FDA’s new human factors engineering guidance for medical device submissions

Emergo Group’s Human Factors Research & Design team takes a closer look at new FDA HFE guidance for medical devices.

Emilee Stanczyk, Emergo Group

The FDA issued a new draft HFE guidance document, Content of Human Factors Information in Medical Device Marketing Submissions, on Dec. 9, 2022. The guidance aims to help medical device manufacturers determine what evaluation information should be included in marketing submissions for medical devices. This post summarizes the guidance and describes the submission categories and evaluation information needed for each category.

The new guidance is intended to complement the FDA’s final HFE guidance from 2016, Applying Human Factors and Usability Engineering to Medical Devices. The new guidance outlines what evaluation information to include in a marketing submission, as noted above, but does not describe how to perform a human factors evaluation; this is where the 2016 draft guidance remains particularly rele…

Brazil’s ANVISA plans major medical device registration updates

Kathryn Burke, Emergo Group

Brazil’s medical device market regulator, ANVISA, announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of March 1, 2023.

The updates (link in Portuguese) to RDC No. 185/2001 further define the rules for classifying the risk of medical devices, the requirements for labeling and instructions for use and the procedures for notification or registration of medical devices.

The resolution’s major changes include:

Adoption of specific classification rules for new technologies including software as a medical device (SaMD) and nanomaterials. The updated classification rules generally align with EU MDR classifications. Consolidation of notification, registration and change rules in a single RDC. Incorporation of rules for the Documentary Repository of Medical Devices. Note: t…

What is the latest on FDA emergency use authorizations?

FDA has 26 active guidance documents related to special recommendations for medical devices during the COVID-19-associated public health emergency.

Medical device types covered include personal protective equipment (gloves, masks, etc.), certain remote assessment and monitoring devices, ventilators, sterilizers, disinfectants, infusion pumps, thermometers and telethermographic systems, digital health devices for treating psychiatric disorders, and diagnostic tests for COVID-19.

The EUA route is intended to provide an expedited route to the US market for devices that could help address the public health emergency. The FDA has not published specific timeframe expectations for these applications, and in Emergo’s experience, the time to authorization is highly variable, and has generally increased with the duration of the public health emergency.

Get the full story on Emergo’s website.