The Ombu Library, in the Medical Device Risk Management aisle, explains the method for documenting a Hazard Analysis using an Excel worksheet. ISO 14971:2007 (and the European variant) is a process standard that outlines a method to identify hazards and reduce the associated risks to an acceptable level. The standard requires traceability through the process. The most common approach uses an Excel workbook in which the columns represent the process steps and the rows have the analysis information for the hazard.

FDA published the 2017 version of Chapter 5 Establishment Inspections of the Inspections Operations Manual. The 127 page document provides detailed information on conducting establishment inspection, including device establishments.

It is available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-ice/documents/document/ucm150576.pdf

The Ombu Library, in the Medical Device Regulations aisle, has an article, Documenting Changes Using the 510(k) Guidance, that explains the changes in a medical device and when they trigger the threshold for a new 510(k).

A manufacturer can change a device using either a design change or a production/process change. Evaluate each change to determine if it triggers a new 510(k). If it does not, review all changes since the most recently cleared 510(k) to determine if the cumulative changes trigger a new 510(k).

FDA announced an update to eSubmitter. For device manufacturers, this free software prepares files for submission to the FDA gateway. It includes both MDRs and Correction and Removals reports.

It is not clear from the announcements what will happen to files stored in eSubmitter after updating a manufacturer implements version 3.0.0. Also, eSubmitter interfaces with software to transmit the prepared files to the gateway; the need to revise the interface is not clear.

Software Disposition Notice

The FDA has begun disposition of eSubmitter 2.x.x. The agency will be providing an updated version (3.0.0) of this software in December 2017, which will require a new installation. eSubmitter 2.x.x can continue being used until 5/7/2018, at which point it will be disabled. If you have any questions or concerns please contact the eSubmitter help desk.

The Ombu Library, in the Quality Auditing aisle, has an article on identifying EU NBs and MDSAP AOs. The article has pointers to the master list in each case.

The Ombu Library, in the Medical Device Risk Management aisle, has an article on the relationship between the ISO 14971:2007 hazard analysis and the pFMEA for the device production process.