Approval of an Investigational Device Exemption (IDE) submission must occur by the FDA before a manufacturer can begin a (moderate to high risk) clinical investigation of its medical device in the US.
Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.
Latest Glossary Definitions
Innovation meetings are held by major EU Member States Competent Authorities (CA) to help organizations that are developing innovative medical devices (or using novel manufacturing processes) navigate the regulatory processes so they can progress their technologies.
A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action
A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the National Competent Authority.
The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal requirement from the 2010 pharmacovigilance legislation.
When developing a medicinal product, two milestones are of importance for making its path to the market: the granting of a marketing authorization from regulatory agencies and the proof of the medicinal product’s usefulness to the healthcare system.
Possibly the highest level of medicine-like health claim that can be made on a non-drug product. It describes the propensity for the product or dietary ingredient to aid in the reduction of the risk factors associated with particular diseases.
The FDA is a Federal agency within US Department of Health and Human Services, which is the primary regulating body of Food and Drug substances in the USA.
A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and approved drug products.
Notified Bodies NB are independent testing laboratories or product certifier companies accredited by EU Member States to perform conformity assessment tasks specified in the Medical Devices Directives (i.e. quality system audits, device compliance testing, etc.).