Why the FDA Increase Software Classification from Moderate LOC to Major LOC?

From our advisory board member Mr. Mike Zeevi

Dear all,

These are very trying times and we are trying our best to keep it together. This year, as you can understand, has been quieter than previous years, in terms of updates to the software from a regulatory and quality perspective. I have done my due diligence and have prepared this update, even though it is not as jumping as previous updates.

I am sending an update on software development standards and good practices as I have done in the past. Hopefully, this will give you new insights on how to relate to some of the issues happening in the regulatory/quality/technical field.

Life is becoming more difficult for the software developer. More recalls; tougher standards.

There are issues that are facts and there are issues that are opinions. Please try to relate to them accordingly.

Due to the corona emergency measures, it may seem that the level of software for submissions to the FDA for software has decreased, but it hasn’t. The FDA is returning more and more projects that were originally classified as Moderate LOC as Major LOC, with all of its implications.

More and more questions are being asked concerning cybersecurity, even though the FDA has not moved forward yet with the new draft guidance for cybersecurity. This is due to the corona wards now transmitting all patient information outside the ward to cut down on the contact with the corona patients.

We have entered a new world where virtual meetings and virtual audits are the norms. You may ask if this makes life easier or harder. The answer is yes.

Please pass this onto all colleagues and compatriots. If there are any questions or comments, please feel free to contact me. If any receiving this indirectly wants to get onto the distribution list, please contact me.

A copy of the attached document is found on our website: www.softquest.co.il under Updates.

GET THE FULL ARTICLE: Software Update 30Jun2020