Looking back on FDA’s inspectional observations issued throughout 2016, inadequate CAPA procedures topped the list at 344, followed by poor complaint handling and lack of written MDR procedures.
Given its top spot among the list of device-related compliance issues in 2016, it’s clear regulators will be putting CAPA under the microscope throughout 2017 and beyond.
While we’ve discussed the essential components of CAPA in the past, it’s worth taking a closer look at the particular CAPA-related issues cited by regulators over the past year to guide your own internal evaluation process, which may be in need of proactive improvement.Continue Reading
On December 28th, The US Food and Drug Administration (FDA) issued its finalized guidance for postmarket cybersecurity management for medical devices.
Most of the recommendations in the final guidance are in line with the draft version released last January, however regulators have made some important changes, specifically related to cybersecurity vulnerability disclosure, participating in Information Sharing Analysis Organizations (ISAOs) and remediating and reporting medical device cybersecurity vulnerabilities.