Medical Products in the NorthwestLast week’s Life Science Innovation Northwest conference offered a diverse look at the research and commercialization of medical products (both pharmaceuticals and medical devices) currently underway in the Pacific Northwest. Attendees...
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MDEpiNet and the Women’s Health Coordinated Registry Network
One goal of the FDA’s Medical Device Safety Action Plan (see my previous post on the plan) is to support an improved national medical device evaluation and surveillance system. The Medical Device Epidemiology Network (MDEpiNet) is a public-private partnership...
IVDDs for Detection of Bacillus Species are Class II Devices
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...
Don’t Miss the FDA Regulatory Education for Industry Conference
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...
Artificial Intelligence (AI)/Machine Learning (ML) Based Software
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...
Guidance on Rare Disease Natural History Studies
This March, CDER, CBER, and the Office of Orphan Products (OOP) issued a draft guidance describing their current thinking on the performance of natural history studies.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...
Pharmaceutical Quality Systems and Established Conditions
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)...
The National Evaluation System for Health Technology = Device RWE
A clear understanding the total product life cycle of a medical device requires much more data than is available in routine regulatory submissions. The FDA has recognized that a national system to collect and analyze Real World Data (RWD) and convert it to Real World...