Documenting Changes Using the 510(k) Guidance (November, 2017 – 1 Page)

FD&CA Amended for Accessories (September, 2017 – 1 Page)

Use of FDA Approved (May, 2017 – 1 Page)

Article on Signatures, Initials, and Stamps (May, 2017 – 3 Pages)

Determining When a Device is 510(k) Exempt (January, 2017 – 2 Pages)

Understanding the Versions of Risk Management Standards (December, 2016 – 3 Pages)

Initial Importer (November, 2016 – 2 Pages)

Design Changes and 510(k) Submissions (October, 2016 – 4 Pages)

Out of Calibration Equipment (October, 2016 – 2 Pages)

Complaints and Reliability (October, 2016 – 2 Pages)