MEDIcept Insights
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
The U.S. Food and Drug Administration recently published a final guidance focusing on reprocessing of reusable medical devices. The new recommendations contained in the guidance are intended to help manufacturers develop safer reusable devices. Medical devices...
Reporting adverse effects event as both a user facility AND a manufacturer (Part II)
As we discussed in our last blog post, the FDA has put manufacturers of LDTs on notice that they must begin notifying the FDA if they are developing LDTs and begin reporting significant adverse effects, according to the draft guidance entitled FDA Notification and...
Overview: Adverse effects reporting (Part I)
With the issuance last Fall of the US Food and Drug Administration (FDA) draft guidance entitled FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), the agency has put manufacturers of LDTs on notice that they must begin notifying the...
Medical Software: The mobile market and the FDA
It’s been predicted that mobile devices are poised to overtake traditional desktop computers as the channel of choice for accessing the Internet. With the variety of devices and their computing power increasing rapidly, growing numbers of patients and healthcare...
Making changes to current LDTs – what do I need to report?
So you've already formally notified the Food and Drug Administration of a laboratory developed test (LDT) for an in vitro device your clinical lab has introduced as required by the FDA. After the initial launch, your clinical lab manager has made a few revisions to...
Responsibilities under new FDA guidelines for reporting current and under-development LDTs
In 1976, landmark federal legislation was passed to create a comprehensive system for the regulation of medical devices intended for use in humans. Congress enacted the Medical Device Amendments (MDA), revising the Federal Food, Drug, and Cosmetic Act (FD&C) and clarifying the categorization of in vitro diagnostic devices (IVDs) as medical devices.