FDA Draft PriorityDevices for Human Factors Review

FDA issued a draft guidance entitled “`List of Highest Priority Devices for Human Factors Review.” FDA is issuing this draft guidance document in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions. For device types listed the guidance suggests that information indicated in the new Final HFE/UE guidance be included in the premarket submissions or should provide a detailed rationale that supports the conclusion that human factors data are not necessary. The guiidance also indicates FDA may recommend or require human factors data be included in premarket submissions through other guidance or on a case-by-case request basis by reviewers. It is interesting that the list of device types in this guidance does not include all high risk devices and no radiation emitting or radiation therapy devices are included. The full guidance is at the link provided.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.