Medmarc Blog (blog.medmarc.com)
Medical Device Manufacturers (5)
DOJ to Ramp up Scrutiny of Clinical Trial Fraud
The U.S. Department of Justice has recently announced several actions in connection with alleged clinical trial fraud, but going forward, this point of emphasis will not be incidental for...
The United Kingdom’s MHRA Moved towards a New Regulatory Framework for Medical Devices
Brexit has given regulatory bodies in the United Kingdom (UK), such as the Medicines and Healthcare products Regulatory Agency (MHRA), great freedom. They are using that freedom to pave the way...
The MDCG’s New Guidance on Classification of Medical Devices
In October 2021, the Medical Device Coordination Group (MDCG) published a guidance to aid medical device manufacturers in complying with classification rules in the European Medical Device...
CMS Announces Full Withdrawal of MCIT Rule
The Centers for Medicare & Medicaid Services has fully withdrawn the rule for Medicare Coverage of Innovative Technology (MCIT), which eliminates any prospect for automatic coverage of...
Device Makers Beware: Device Design a Hazard in New FDA Intended Use Rule
Device makers should be aware of the new FDA intended use rule, which concludes an overhaul of the previous version that was six years in the making. One of the key differences between the new...
Are You Remanufacturing or Servicing the Product?
On June 17, 2021, the FDA issued a draft guidance for remanufacturing medical devices. With this guidance, the FDA aims to distinguish between remanufacturing and servicing and to instruct the...
Is My Product a Drug or a Device? The D.C. Circuit Court Weighs in on this Question
There are several important differences between FDA regulations of pharmaceuticals and medical devices. These differences span from regulation of promotion and advertising to the testing...
FDA Guidance for Medical Devices in MRI Facilities/Magnetic Resonance Environments - and What It Means for Products Liability
The FDA has issued final guidance for testing and labeling medical devices for safety in the magnetic resonance environment. This guidance will be essential for manufacturers of both implantable...
CMS Adds Administrator, Hits Pause on MCIT
CMS Adds Administrator, Hits Pause on MCIT The Center for Medicare & Medicaid Services has a new administrator, Chiquita Brooks-LaSure, signaling an end to a leadership void at an agency that is...
Industry: FDA Staffing a Key User Fee Issue
Negotiations are underway between the FDA and industry regarding MDUFA V, the fifth medical device user fee agreement, but there are still some issues with the current agreement. One of those,...