A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action
Latest Glossary Definitions
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 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.
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.
The European network for Health Technology Assessment is a network of government-appointed organizations from European Union Member States, the European Economic Area and accession countries as well as a large number of relevant regional agencies and non-for-profit organizations that produce or c
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.
A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and approved drug products.
ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, and is the most commonly chosen path for companies to meet QMS requirements in major international markets (i.e. Europe, Canada, Japan, Australia etc.).
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.).
A NDA is the final step formally taken by a drug sponsor, wherein it applies to the Food and Drug Administration (FDA) for the approval required to market a new drug in the U.S.