Significant risk device definition

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

  • A sponsor shall submit to FDA a copy of any report by an investigator under paragraph (a)(5) of this section of use of a device without obtaining informed consent, within 5 working days of receipt of notice of such use.(9) Significant risk device determinations.

  • 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.

  • In preparation for this a gradual phase in approach to increases in tariffs has been adopted.

  • Significant risk device studies require both FDA and IRB approval.

  • By adding new § 812.64 to read as follows: § 812.64 IRB’s continuing review .The IRB shall conduct its continuing review of an investigation in accordance with Part 56.j- By adding new § 812.66 to read as iollows:§ 812.66 Significant risk device determinations.If an IRB determines that an investigation, presented for approval under § 812.2(b)(l)(ii), involves a significant risk device, it shall so notify the investigator and, where appropriate, the sponsor.

  • Significant risk device studies must be conducted in accordance with the complete requirements of the IDE regulations and necessitate the prospective approval of an IDE application by the FDA and approval by the IRB.

  • 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.

  • Significant risk device determinations 21 CFR 812.150bIf an IRB determines that a device is significant risk, whereas the sponsor-investigator hadproposed it to be a non-significant risk device, the sponsor-investigator must notify the FDA of this decision within 5 working days after learning of the IRB’s determination.

Related to Significant risk device

  • Cephalometric device means a device intended for the radiographic visualization and measurement of the dimensions of the human head.

  • 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.

  • 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

  • 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.

  • 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.

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • COVID-19 Pandemic means the SARS-Cov2 or COVID-19 pandemic, including any resurgence or evolutions or mutations thereof and/or any related or associated outbreaks, epidemics and/or pandemics.

  • 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 which meets the needs of the present 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.

  • business vertical means a distinguishable component of an enterprise that is engaged in the supply of individual goods or services or a group of related goods or services which is subject to risks and returns that are different from those of the other business verticals.

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

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

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

  • Diatomaceous earth filtration means a process resulting in substantial particulate removal in which a precoat cake of diatomaceous earth filter media is deposited on a support membrane (septum), and 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.

  • Gasification means the substoichiometric oxidation or steam reformation of a substance to produce a gaseous mixture containing two or more of the following: (i) oxides of carbon; (ii) methane; and (iii) hydrogen;

  • Clone means a non-flowering plant cut from a mother plant that is capable of developing into a new plant and has shown no signs of flowering.

  • Traffic control device means a flagger, sign, signal, marking, or other device used to regulate, warn or guide traffic, placed on, over, or adjacent to a street, highway, private road open to public travel, pedestrian facility, or shared-use path by authority of a public agency or official having jurisdiction, or, in the case of a private road open to public travel, by authority of the private owner or private official having jurisdiction.

  • COVID-19 test means a viral test for SARS-CoV-2 that is:

  • COVID-19 Measures means any quarantine, “shelter in place”, “stay at home”, workforce reduction, social distancing, shut down, closure or sequester order, guideline, recommendation or Law, or any other applicable Laws, guidelines or recommendations by any Governmental Entity in connection with or in response to COVID-19.