MEDIcept Insights
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With the issuance last Fall of the US Food and Drug Administration (FDA) draft guidance entitled FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), the agency has put manufacturers of LDTs on notice that they must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.
Health Hazard Analysis Tips
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...
M&A regulatory due diligence
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...