FDA Insights | Sumble

What is FDA?

The Food and Drug Administration (FDA) is a federal agency responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, blood transfusions, medical devices, veterinary products, and cosmetics. It ensures these products are safe, effective, and properly labeled. The FDA also regulates the manufacturing, marketing, and distribution of these products.

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What other technologies are related to FDA?

FDA Competitor Technologies

EMA

The European Medicines Agency (EMA) is a regulatory agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines. The EMA acts as a competitor in that it is the equivalent in Europe

mentioned alongside FDA in 14% (233) of relevant job posts

MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK regulatory body responsible for ensuring the safety, quality, and efficacy of medicines and medical devices. Functions similarly to the FDA.

mentioned alongside FDA in 43% (55) of relevant job posts

EU MDR

The European Union Medical Device Regulation (EU MDR) is a regulatory framework for medical devices sold in the EU. Alternative to FDA regulation.

mentioned alongside FDA in 13% (114) of relevant job posts

MDR

Medical Device Regulation. Could be EU MDR, or other countries' MDRs that are competitors to FDA.

mentioned alongside FDA in 5% (183) of relevant job posts

MDD

Medical Device Directive (MDD) was the previous EU regulatory framework for medical devices. It's superseded by the EU MDR, but it still relevant as past regulation and can be considered a competitor to FDA.

mentioned alongside FDA in 13% (53) of relevant job posts

FDA Complementary Technologies

ISO 13485

ISO 13485 specifies requirements for a quality management system specific to medical devices. Compliance can facilitate FDA approval.

mentioned alongside FDA in 7% (834) of relevant job posts

GMP

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. GMP is often used in the context of FDA regulations.

mentioned alongside FDA in 6% (891) of relevant job posts

ICH

The International Council for Harmonisation (ICH) develops guidelines for pharmaceutical product registration. These guidelines are often adopted by regulatory bodies like the FDA.

mentioned alongside FDA in 20% (232) of relevant job posts