Novel feeds are feeds composed of or derived from microorganisms, plants, or animal sources that are not approved as feed in SFDA and/or contain a novel trait

Means written, printed or graphic matter
a) Affixed to a medical device or any of its containers or wrappers.
b) Information accompanying a medical device, related to identification, technical description.
c) Information accompanying a medical device, related to its use, but excluding shipping documents.

In-Vitro Medical Device:
Means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software and related instruments or apparatus or other articles

Means a product intended specifically by its manufacturer to be used together with a medical device to enable that medical device to achieve its intended purpose.

Most pathogens are destroyed between 140 and 160 °F. However, for best quality, meat and poultry require various temperatures for "doneness." A chart, listing safe internal temperatures for many foods, is part of the brochure Use A Food Thermometer, featuring Thermy™. For more information, visit the Thermy™ Web pages.

The temperatures on the chart are recommended for consumer cooking. They are not intended for processing, institutional, or foodservice preparation. Food service professionals should consult their state or local food code.

Any material from which ionizing radiation is emitted, whether alone or within other equipment, classified as subject to the control of the SFDA. Including, naturally occurring radioactive materials.

Means the total days of ALL 3 cycles is 60 days to fulfill all the requirements. In occasions where applicant have a valid justification to extend the response period for SFDA’s observations to more than 60 calendar days, such requests must be emailed to
mdma.it@sfda.gov.sa.

A medical device may be designated as an Innovative Medical Device if it has an innovative feature in the technology, indications of use, or performance specifications that have no equivalence in the market. Furthermore, it is in the best interest of the patients, and at least one of the following criteria is met:
• the device provides considerable clinical advantages over an existing SFDA approved technology; OR
• the device provides considerable clinical advantages over an existing approved alternative treatment; OR
• there are no SFDA approved alternative technologies nor treatments available to patients

These are studies that are conducted with a scientificmethodology on a medical device to verify its safety / effectiveness as a result of the presence of safety signals on that device that is marketed locally