Inhalers, Spacers FDA CDRH 510(k) Nebulizers

“Reviewer Guidance For Nebulizers, Metered Dose Inhalers, Spacers andActuators.”

This document was issued on October 1, 1993. It provides guidance on 510(k) submissions for these devices. It states in section V.C several references related to software including the requirement for detailed discussions of software related device features if there are any. And if there is software in the device then a hazard analysis, software requirements and design information, test plans and protocols with appropriate data and test reports, and documentation of the software development process, inculding the configuration management plan are all required. It also references the now obsolete reviewer guidance for computer controlled medial devices, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” and the current FDA submission guidance, “Guidance for the DContent of Premaket Submissions for Software Contained in Medical Devices,” should be used in its place.

In subsection E it emphasizes that If the device is a modified or enhanced version of a legally marketed device, modifications, if any, in software should be identified and each modifictaion should have some explanitory rational of whether or not the modifications are being implemented to correct problems.

SoftwareCPR Training Courses:

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

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

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

Instructor: Brian Pate

Next public offering:  TBD

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Being Agile & Yet Compliant (Public or Private)

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

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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Medical Device Cybersecurity (Public or Private)

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)

Next public offering:  TBD

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