Glossary

A device used for sealing fluids with rotating shafts. A mechanical seal is a prefabricated or packaged assembly that forms a running seal between flat surfaces.

Medical Dictionary for Regulatory Activities Terminology

Substances used to provide sterile nutrients to the fermentation or cell growth process supporting the growth of the live microorganisms. Media may be liquid (broth) or solid, and generally include sucrose or glucose as a carbon source, various minerals, a nitrogen source, and selected growth factors.

Method used to evaluate the efficacy of an aseptic process by substituting microbiological media for the normally processed product; also known as Process Simulation Test or Aseptic Process Simulation.

The act of preparing nutrient media for cell culture or fermentation.

(ISO/DIS 10993-1) Any instrument, apparatus, appliance, material, or other article, including software, whether used alone or in combination, intended by the manufacturer to be used for human beings solely or principally for the purpose of:- diagnosis, prevention, monitoring, treatment, or alleviation of disease;- diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap;- investigation, replacement, or modification of the anatomy or of a physiological process;- control of conception;and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.Note 1 – Devices are different from drugs, and their biological evaluation requires a different approach.Note 2 – Use of the term “medical device” includes dental devices.

A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body. Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment.

These amendments greatly increased the FDA's control over medical devices. The amendments gave the FDA power to ban medical devices, to require manufacturers to inform consumers of potential hazards, and to force manufacturers to give refunds.

Any health care product that does not achieve its principal intended purposes by chemical action in or on the body or by being metabolized. The term “devices” also includes components, parts, or accessories of medical devices, diagnostic aids such as reagents, antibiotic sensitivity disks, and test kits for in vitro diagnosis of diseases and other conditions. There are three classes of medical devices:1.Class I, General Controls (registration of manufacturers, recordkeeping and labeling requirements, compliance with GMPs).2.Class II, Special Controls (including performance standards, posmarket surveillance, and patient registries).3.Class III, Premarket Approval (implanted and life supporting or life sustaining devices).

Medication guides are paper handouts/pamphlets that are required to be distributed to patients with certain medications by the pharmacist. Medication Guides convey risk information that is specific to particular drugs and drug classes, and that contain FDA-approved information that can help patients avoid serious adverse effects.

Any substance or combination of substances presented for treating or preventing disease in human beings or animals.Any substance or combination of substances that may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.

Any substance or combination of substances presented as having properties for treating or preventing disease in human beings or any substance or combination of substances that may be used in or administered to human beings with a view to restoring, correcting or modifying physiologic functions by exerting a pharmacological, immunological, or metabolic action, or to making a medicinal diagnosis.

(plural: Media) 1. In plant tissue culture, a term for the liquid or solidified formulation upon which plant cells, tissues or organs develop.2. In general terms, it could also means a substrate for plant growth, such as nutrient solution, soil, sand, etc., e.g., potting medium.

The material from which a filter is constructed.

Systems or functions that typically have an indirect impact on data integrity, product quality or patient safety.

A classification of ICs [chips] based on their size as expressed by the number of circuits or logic gates they contain. An MSI IC contains 100 to 3,000 transistors.

MedWatch is FDA’s safety information and adverse event reporting program. It provides important and timely medical product information to healthcare professionals, including information on prescription and over-the-counter drugs, biologics, medical devices, and special nutritional products. Health care professionals and consumers can also report serious problems they suspect are related to certain FDA-regulated products.

MedWatch provides important and timely medical product information, and is also a venue for reporting adverse events to FDA. You can sign up to receive MedWatch notices by e-mail.

An FDA program designed to monitor adverse events (AE) from drugs marketed in the U.S. Through the MedWatch program, health professionals may report AEs voluntarily to the FDA. Drug manufacturers are required to report all AEs brought to their attention.

Unit of length for DNA fragments equal to 1 million nucleotides and roughly equal to 1Centimorgan (cM)

Approximately one million bits. Precisely 1024 K bits, 220 bits, or 1,048,576 bits.

Approximately one million bytes. Precisely 1024 K Bytes, 220 bytes, or 1,048,576 bytes.

A unit of frequency equal to one million cycles per second.

A measure of ionic purity in water.

The special cell division process by which the chromosome number of a reproductive cell becomes reduced to half (n) the diploid (2n) or somatic number. Two consecutive divisions occur. In the first division, homologous chromosomes became paired and may exchange genetic material (via crossing over) before moving away from each other into separate daughter nuclei (reduction division). These new nuclei divide by mitosis to produce four haploid nuclei. Meiosis results in the formation of gametes in animals or of spores in plants. It is an important source of variability through recombination.