FDA Final MDDS Guidance

FDA issued a final version of its guidance for “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” The document is dated February 9, 2015, although it was issued several days prior. This guidance is very significant as it states FDA is exercising discretion and not requiring compliance to the recent regulation for MDDS and goes further to indicate this also applies to Medical Image Management Communication and Storage Devices. The excerpt which indicated this is repeated below and the full guidance is at the link provided.

“This means that for devices that meet the definitions in the regulations listed above, the FDA does not intend to enforce compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting, and quality system regulation for manufacturers of these types of devices.”

FDA MDDS Final Guidance

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.