In a previous post, we discussed several of the terms key to the regulatory approval process for drugs and biologics. In this post, we focus on acronyms, abbreviations, and unique terms that industry insiders use in discussions about the regulation and approval of medical devices.
If you’re not as familiar with this space as you might like to be, read on.
CE Mark
CE Mark stands for “Conformité Européenne” mark. This applies to medical devices marketed in the European Union and refers to the mark that medical device manufacturers can place on a device once it has passed a conformity assessment. The conformity assessment typically involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of the technical documentation from the manufacturer on the safety and performance of the device.
IDE
IDE stands for “Investigational Device Exemption.” This exemption allows for an investigational device to be used in a clinical study so that safety and effectiveness data can be collected.
HDE
HDE stands for “Humanitarian Device Exemption.” This exemption refers to the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices — those generally used to sustain or support life, as well as those potentially presenting unreasonable risk of illness or injury. For example, implantable pacemakers and breast implants fall into the category of Class III devices.
HUD
HUD stands for “Humanitarian Use Device.” The phrase pertains to those devices that are meant to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 8,000 individuals per year in the United States.
PMA
PMA stands for “Premarket Approval” and describes the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. It is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants in addition to laboratory testing. For devices not requiring a PMA, a 510(k) must be submitted to market in the U.S. a Class I, II, and III device intended for human use. Devices that are exempt from 510(k) requirements of the FD&C Act and do not exceed the limitations of exemptions in .9 of the device classification regulation chapters do not require 510(k) submission.
PMDA and MHLW
PMDA stands for “Pharmaceuticals and Medical Devices Agency” while MHLW stands for “Ministry of Health, Labour, and Welfare.” Together, they are the regulatory bodies that review and approve drugs and medical devices in Japan.
Need to know more about these terms, the processes they reference, or anything associated with communicating with FDA and other regulatory authorities? We at Pearl Pathways are ready to help. Reach out to us any time.
Did you miss our previous post on terms associated with drugs and biologics? You can find it here.