Katrina’s Blog™

On April 1st, the FDA issued a final rule that classifies In Vitro Diagnostic Devices (IVDD) for Bacillus Species Detection as class II devices requiring premarket notification through the 510(k) review process. The purpose of this type of device is to detect and...

It's Available Virtually in Late MayCDER and CDRH are hosting the annual Regulatory Education for Industry conference on May 29-30th. Attendees may participate in person at the The Revere Hotel in Boston, MA or virtually using Adobe Connect, and the event registration...

The FDA Proposes a Quality System Regulatory Framework for Modifications to AI/ML Software as a Medical Device (SaMD)A discussion paper was posted this month to request feedback on a proposed regulatory framework for AI/ML SaMD. The current regulatory framework is...

This March, CDER, CBER, and the Office of Orphan Products (OOP) issued a draft guidance describing their current thinking on the performance of natural history studies. This type of study is used to collect information on the course of a particular disease and to...

The product lifecycle is a well-known concept in quality circles that is finding increasing use in the pharmaceutical and medical device community.  Key to the understanding of a product are the elements of Chemistry, Manufacturing and Controls (CMC)...