scope:

This TIR was developed to provide background and information regarding HFE/UE activities and their corresponding applicability to DESIGN CONTROLS in accordance with 21 CFR 820.30. The scope of this TIR applies to all developers and MANUFACTURERS of medical devices and combination products that contain a device constituent part. The TIR is for those MANUFACTURERS intending to commercialize products in the United States and therefore does not address all requirements for commercializing products outside the U.S.

While this TIR presents specific recommendations for aligning HFE/UE processes to DESIGN CONTROLS, it is recognized that MANUFACTURERS may develop their own methodologies, processes, and customized QUALITY SYSTEMS in order to ensure compliance with 21 CFR 820.30 and other regulations. MANUFACTURERS should consider evaluating the recommendations in this TIR and the resultant impact to their existing QUALITY SYSTEMS and processes, including compliance with ANSI/AAMI/ISO 13485 and ANSI/AAMI/ISO 14971, as applicable.

This TIR presents specific DESIGN CONTROLS activities as specified in 21 CFR 820.30; however, it does not cover all elements within 21 CFR 820 or 21 CFR 820.30. The focus of this TIR is DESIGN CONTROLS activities that overlap functionality with HFE/UE processes, leading to robust HFE/UE documentation in support of a MANUFACTURER'S DESIGN HISTORY FILE [21 CFR 820.30 (j)] and HFE/UE FILE [ANSI/AAMI/IEC 62366-1:2015]. In addition, MANUFACTURERS establish QUALITY SYSTEMS to be compliant with 21 CFR, as well as ANSI/AAMI/IEC 62366-1:2015 (referred to as "ANSI/AAMI/IEC 62366-1" throughout this document), and the scope of these systems is dependent on multiple variables, such as overall MANUFACTURER size and device complexity. As such, this TIR is intended to provide general overviews, recommendations, and deliverables with respect to DESIGN CONTROLS and HFE/UE for MANUFACTURERS to utilize and customize according to their own QUALITY SYSTEMS and procedures.

Figure 1 below provides a detailed mapping of HFE/UE integration as part of DESIGN CONTROLS where activities performed produce HFE/UE deliverables. Some of these deliverables are considered "live" and are required to be updated when new information is produced. For instance, "Updated RISK ANALYSIS" is a HFE/UE deliverable due to activities produced in DESIGN OUTPUT, VERIFICATION, VALIDATION, Submission, and In Market after the initial RISK ANALYSIS deliverable performed in DESIGN INPUTS.