Medical Devices; Hematology and Pathology Devices

Medical Devices; Hematology and Pathology Devices; Reclassification of Automated Blood Cell Separator Device Operating by Filtration Principle from Class III to Class II

Posted: 2/28/2003, Publish Date: 2/28/2003

This announcement reclassifies these device so that 510(k)s instead of PMAs can be used. It also establishes a special control. This control requires filing annual reports for each of 3 years. These annual reports to FDA include information related to software in addition to other information. The software related excerpts are listed below and the full notice is at the link provided.

It is also interesting to note that FDA provides an explicit list of hazards for these devices which could be useful as a starting point for device or software risk analysis.

The following text are software related references found in this document

2. Any change to the device, including but not limited to:
– new indications for use of the device;
– labeling changes, including operation manual changes;
– computer software changes, hardware changes, and disposable
item changes, e.g., collection bags, tubing, filters;
3. Equipment failures, including software, hardware, and disposable
item failures, e.g., collection bags, tubing, filters.
(2) Any change to the device, including but not limited to:
(i) New indications for use of the device;
(ii) Labeling changes, including operation manual changes;
(iii) Computer software changes, hardware changes, and disposable
item changes, e.g., collection bags, tubing, filters;
(3) Equipment failures, including software, hardware, and disposable item failures, e.g., collection bags, tubing, filters.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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