FDA Guidance Recalls versus Enhancements

The FDA issued a gudance entitled “Distinguishing Medical Device Recalls from Medical Device Enhancements” dated 15-Oct-2014. This guidance provides a series of examples as well as some explanation to help distinguish recalls, corrections, removals, and enhancments of medical devices. A number of the examples are for software changes. Some general principles relate to whether the change is being made because the device does not meet its specificaitons and claims and whether the device is violative (not in compliance with FDA law/regulation).

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

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