|Recognition List Number: 022 FR Publication Date: 09/08/2009
Part B: Supplementary Information
Recognition Number 5-50: IEC 62366, medical devices - application of usability engineering to medical devices. (General I (QS/RM))
Date of Standard: 2007.
|Address of Standards Development Organization:|
| International Electrotechnical Commission (IEC)|
| 3, Rue de Varembe'|
| PO Box 131|
| CH-1211 Geneva 20, 0 |
|CDRH Offices and Divisions associated with recognized standards:|
|(1)||OFFICE OF COMPLIANCE (OC) |
|(2)||OFFICE OF COMPLIANCE (OC) |
|(3)||OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL) |
|Processes Affected: |
|510(k), IDE, PMA, PDP, HDE|
|Type of Standard:|
| Horizontal, International|
|Extent of Recognition:|
|This standard describes a process for integrating human factors engineering in the form of a comparable term "Usability Engineering" into the product design and development process necessary to satisfy FDA Quality Systems-Design Control requirement to ensure that the needs of the user are appropriately defined, verified and validated. |
Any declaration of conformance to this standard with respect to the design and development of any particular medical device should be accompanied by the following documentation at a minimum:
1. A pictorial representation and functional description of the device user-interface including logic and sequence of interaction under differing circumstances of use.
2. Instructions for use.
3. A description of user profiles for intended users, intended operating conditions, potential hazards with the use of the device including reasonably foreseeable use errors relevant in defining and evaluating the adequacy of the device-user interface.
4. Summary description of the risk analysis relevant to the device user interface and its possible role in permitting or contributing to use error, including risks associated with incorrect actions, lack of action when necessary, misunderstanding, not perceiving device output, or lack of essential knowledge necessary for proper device operation.
5. Usability specifications should focus on specific risks prioritized by assessed risk level of use error and incorporate both performance and subjective assessment.
6. Summary description of tasks and activities conducted to verify that the device-user interface design output is compatible with established design input requirements.
7. Summary description of device-user interface design validation activities including demonstration of safe use by representative users under reasonably realistic simulated conditions of use and rationale for acceptability of residual risks; failures for high risk tasks or scenarios of use should be either nonexistent or result from explainable experimental artifact.
Any declaration of conformance to this standard with respect to establishing a manufacturer's standard design and development process (i.e., "Deign Controls") adequate to meet the needs of the user should be accompanied by the following documentation at a minimum:
1. Description of the process to be followed in defining the user needs to establish the device-user interface design input to include the need for design features that will enhance safety in the form of prevention or minimization of risk of unintentional errors by users.
2. Description of the process to be followed in verifying that the user needs as defined by the design input are addressed by the design output.
3. Description of the risk analysis process to be followed in identifying and assessing and mitigating reasonably foreseeable risks associated with intended use.
4. Description of the process to be followed in validating that the final design functions in a way as to meet the intended user needs and that mitigation to previously identified risks are effective.
|Relevant Guidance: |
|For additional guidance on human factors engineering as it relates to the Quality System Regulation-Design Controls, see DCRH publication "Medical Device Use-Safety: Incorporating Human Factors into Risk Management" available at http://www.fda.gov/cdrh/humfac/1497.pdf|
|FDA Technical Contact:|
| Ron D. Kaye |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2520 |
| Silver Spring MD 20993 |
| 301/796-6289 |
| email: email@example.com|