Significant risk device definition

Significant risk device means an investigational device that:
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Examples of Significant risk device in a sentence

  • Significant risk device studies shall be conducted in accordance with the full IDE regulation [21 CFR 812] and shall not be commenced until: 1) 30 days after the FDA receives the IDE application or the FDA approves, by order, an IDE for the investigation, and 2) the IRB has approved the study.

  • When the HUD is being studied for the indication(s) in its approved labeling, the IDE regulations at 21 CFR 812 do not apply; however, when the HUD is being studied for a different indication(s), 21 CFR 812 does apply, including the requirement for an FDA-approved IDE before starting the clinical investigation of a Significant risk device.

  • Significant risk device studies must have an IDE application approved by FDA before they may proceed and must follow the FDA regulations described in 21 CFR 812.

  • The convened IRB has determined that the device as it will be used in this study is: ☐ Significant risk device – if ANY of the above are checked, the devise is SR ☐ Non-significant risk device– if NONE of the above are checked, the devise is NSR Notes: Click or tap here to enter text.

Related to Significant risk device

  • Significant Industrial User (SIU) means any industrial user that:

  • explosive actuated fastening device means a tool that is activated by an explosive charge and that is used for driving bolts, nails and similar objects for the purpose of providing fixing;

  • Cannabinoid extract means a substance obtained by separating cannabinoids from marijuana by:

  • Control device means equipment (such as an incinerator or carbon adsorber) used to reduce, by destruction or removal, the amount of air contaminants in an air stream prior to discharge to the ambient air.

  • Significant emissions unit means an emissions unit that emits or has the potential to emit a PAL pollutant in an amount that is equal to or greater than the significant level (as defined in section 140 or in the Act, whichever is lower) for that PAL pollutant, but less than the amount that would qualify the unit as a major emissions unit as defined in section 079.

  • Alcohol Screening Device (ASD) means a breath or saliva device, other than an Evidential Breath Testing Device (EBT), that is approved by the National Highway Traffic Safety Administration and placed on its Conforming Products List for such devices.

  • Precursor means any chemical reactant which takes part at any stage in the production by whatever method of a toxic chemical. This includes any key component of a binary or multicomponent chemical system.

  • Controlled substance analog means a substance the chemical structure of which is substantially

  • Commercial cannabis activity means the production, cultivation,

  • Anaerobic digester means a liquid manure storage area that is constructed with the intent to capture and combust gas emissions resulting from the digestion of waste by microbes in anaerobic conditions. An anaerobic digester is a LMSA and is required to comply with all requirements applicable to LMSAs. Requirements specific to anaerobic digesters will be noted when applicable.

  • Assistive device means any item, piece of equipment, or product system which is used to increase, maintain, or improve the functional capabilities of an individual with a disability in the workplace or on the job. “Assistive device” does not mean any medical device, surgical device, or organ implanted or transplanted into or attached directly to an individual. “Assistive device” does not include any device for which a certificate of title is issued by the state department of transportation, but does include any item, piece of equipment, or product system otherwise meeting the definition of “assistive device” that is incorporated, attached, or included as a modification in or to such a device issued a certificate of title.

  • Significant change means a major decline or improvement in the tenant’s status which does not normally resolve itself without further interventions by staff or by implementing standard disease-related clinical interventions that have an impact on the tenant’s mental, physical, or functional health status.

  • Total tetrahydrocannabinol means the same as that term is defined in § 3.2-4112.

  • Orthotic device means a custom-fitted or custom-fabricated medical device that is applied to a part of the human body to correct a deformity, improve function, or relieve symptoms of a disease.

  • Current significant investigative information means investigative information that a licensing board, after an inquiry or investigation that includes notification and an opportunity for the audiologist or speech-language pathologist to respond, if required by state law, has reason to believe is not groundless and, if proved true, would indicate more than a minor infraction.

  • COVID-19 Pandemic means the epidemic, pandemic or disease outbreak associated with COVID-19.

  • information gathering measures means laws and administrative or judicial procedures that enable a Contracting Party to obtain and provide the requested information;

  • Cannabinoid edible means food or potable liquid into which a cannabinoid concentrate, cannabinoid extract or dried marijuana leaves or flowers have been incorporated.

  • sustainable development means development that meets the needs of the present generation without compromising the ability of future generations to meet their own needs;

  • Assistive technology device means any item, piece of equipment, or product system that is used to increase, maintain, or improve the functional capacities of a child with a disability.

  • Assistive Devices means any category of durable medical equipment, mechanical apparatus, electrical appliance, or instrument of technology used to assist and enhance an individual's independence in performing any activity of daily living. Assistive devices include the use of service animals, general household items, or furniture to assist the individual.

  • Significant impact means that the proposal is likely to have a noticeable effect on specific section(s) of the community greater than on the general community at large.

  • Tetrahydrocannabinol means the same as that term is defined in § 3.2-4112.

  • Approved Device means a device described in Subsection 20A-21-201(4) used to

  • coronavirus means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

  • Diatomaceous earth filtration means a process resulting in substantial particulate removal in which (1) a precoat cake of diatomaceous earth filter media is deposited on a support membrane (septum), and (2) while the water is filtered by passing through the cake on the septum, additional filter media known as body feed is continuously added to the feed water to maintain the permeability of the filter cake.