With the issuance of the Draft Guidance  FDA Notification and Medical Device Reporting for LDT late last year, there have been a number of clarifications in its first major attempt to update the Medical Device Amendments (MDA) of the landmark Federal Food, Drug, and...
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...
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begin notifying the FDA if they are developing LDTs and begin reporting significant adverse effects, according to the draft guidance entitled FDA Notification and...
With the issuance last Fall of the US Food and Drug Administration (FDA) draft guidance entitled FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), the agency has put manufacturers of LDTs on notice that they must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...
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...
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...
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.
Health hazard analyses (HHAs) are a necessary part of the medical device manufacturing process since the FDA revised Medical Device Good Manufacturing Practices Regulation, 21 CFR Section 820 in 1996. They were replaced with the Quality System regulations and included...
Proper due diligence is important in any corporate merger and acquisition because investing in or acquiring another company is always risky business, but for medical device companies subject to FDA scrutiny, due diligence is absolutely critical. Too many acquiring...
"Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements." Part 820, Subpart E Section 820.50 Code of Federal Regulations This one, short sentence in the...