FDA Changes to Medical SW Policies Draft Guidance

On Dec. 8, 2017 FDA released a Draft guidance “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”. This guidance dsicusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or will not be regulated. Note, however, that the 21st Century Cures Act allows regulation of devices excluded from regulation if a federal register notice finds it wouild be reasonably likely to have serious adverse health consequences This guidance indicates that 4 other existing FDA software guidances will be modified to incorporate the policies indicated. related to application of these policies on a software function-specific basis and across platforms. These includes the Mobile Medical Applications, Off-theShelf Software (to removeLaboratory Information Management Systems (LIMS)), General Wellness, Medical Device Data Systems guidances. This draft guidance contains many criteria and details regarding FDA’s legal authority (or lack thereof) to regulate medical software and whether if within their authority they will exercise enforcement discretion and not actively regulate. It includes related factors such as whether the software is certified by non-FDA HHS Office of the National Coordinator for Health Information Technology. The full guidance is at the link provided. Policies Resulting from Section 3060 of the 21 3 st Century Cures Act

Upcoming SoftwareCPR Training Courses:

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

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

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

Register here:

https://events.eventzilla.net/e/december-2022-softwarecpr-agile-and-compliant-training-course-2138573767

 

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