MEDIcept Insights
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...
Reducing risk with supplier audits
"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...
HIPAA, Cybersecurity, and Medical Device Manufacturers
Wait a minute, HIPAA regulations have to do with protecting private health information - that's something that hospitals, physicians' practices, and other health organizations have to be concerned about, not medical device manufacturers, right? Wrong. As more and more...
Reducing risk with supplier audits
Are you sure your suppliers meet FDA requirements? “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...