FDA CDRH 510(k)Tomography Devices and Accessories

“Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems”

This documenent was issued on December 3, 1998.

Section VII.D is on software. It provides an itemized list of information to be included in the submission. This list basically is the requirements listed in the current FDA software submission guidance which is also referenced in this section. It does not state a specific level of concern and leaves that to be defined by the manufacturer. In the list of information to be provided it emphasizes that a list of errors and bugs remaining in the device be provided with an explanation of how they were determined not to to effect safety and effectiveness including operating usage and human factors.

Sections VIII.B & VIIII. Device Description for SPECT Devices and PET systems has several explicit references to software. Including that the device description list of major components of the system and their purpose, including related interfacing software. IT fFurther requires descriptions of aqusition processing, and network software, instruction methods, filtering, processing software,and third party software, as well as descriptions of the software that is part of accessory devices; display monitors, hand held or wireless remote control units, and storage devices.

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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

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Instructors: Mike Russell, Ron Baerg

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This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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