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.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

To pre-register and get info on deep discounts or if you have questions, email training@softwarecpr.com

Corporate Office

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