Question stringlengths 13 1.05k ⌀ | Answer stringlengths 2 801 ⌀ |
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What do IEC standards 60601-2-63 and 60601-2-65 use to determine whether the device is an extra-oral device or an intra- oral device? | the location of the image receptor |
What is the applicable standard for all other devices under 21 CFR 892.1650? | IEC 60601-2-54 |
What is the name of the Nonbinding Recommendations Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring Guidance for Industry and Food and Drug Administration Staff Document issued on October 19, 2023.? | null |
When was the COVID-19 Public Health Emergency issued? | March 2020 |
What is the CMC? | chemistry, manufacturing, and controls |
What is the docket number of FDA-2023-D-4356? | FDA-2023-D-4356 |
What is the document number for the guidance? | GUI00020014 |
What does the guidance not establish any rights for? | any person |
What is the FDA's role in protecting the United States from? | emerging infectious diseases |
What was the purpose of this guidance? | to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to address the PHE |
How long does the guidance document continue in effect after the COVID-19 PHE declaration expire? | 180 days |
What is the name of the guidance document that is intended to facilitate patient monitoring while reducing patient and healthcare provider? | COVID-19 |
When did the Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring expire? | May 11, 2023) |
What has FDA evaluated the benefits and risks to patients and healthcare providers of exercising certain enforcement policies? | exercised certain enforcement policies |
What do we recommend you include if submitting a Declaration of Conformity to a recognized standard? | appropriate supporting documentation |
What is the autoinjector designed to meet a specific injection time specification? | autoinjector |
What has FDA determined about the use of consensus standards in regulatory submissions? | prior public participation for this guidance is not feasible or appropriate |
What is the guidance document being implemented immediately? | this guidance document |
Where can you find the Agency guidance? | ERROR: type should be string, got " https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm" |
What does the inal device measure? | common physiological parameters |
What is the name of the pressure measurement system used in the CFR? | Noninvasive blood |
What is the name of the section of the FD&C Act that exempts devices with the product codes listed in Table 1? | 510(k) |
What are the two types of stethoscopes covered by this classification regulation? | manual and electronic |
What is the name of the 510(k) exempt system that PKQ II cognitive assessment is exempt from? | PTY II |
What is not exempt from 510(k) of the FD&C Act? | otoacoustic emission devices |
What is the time of injection that determines the rate of drug delivery? | 266 injection time |
What does FDA believe may trigger the requirement that a manufacturer submit a premarket notification? | modifications to existing otoscopes to allow for increased remote monitoring capability |
What is exempt from premarket notification requirements? | computerized cognitive assessment aid |
What is the requirement for marketing new devices within this device type Until the unclassified device type has been classified through regulation? | null |
What is the name of the non-invasive monitoring device that can be connected to a wireless network to transmit a patient’s measurements directly to their healthcare provider? | The Oximeter |
What is the name of the non-invasive remote monitoring device that was removed from Table 1 compared to previous versions of FDA’s guidance? | Clinical electronic thermometer |
What does FDA not intend to object to? | limited modifications to the indications, functionality, or hardware or software of certain non-invasive remote monitoring devices |
What is a premarket notification called? | 510(k) |
What is CDRH's 2022-2025 strategic priorities? | focusing on advancing health equity |
What can advance better care, quality of life, and wellness of diverse populations? | digital health technologies |
What may require premarket notification if modifications to the indications, functionality, or hardware or software of 510(k)-exempt devices in Table 1 may require? | null |
What is the policy supporting? | this strategic priority |
What did the applicant conduct with the PFS presentation? | phase 3 studies |
What does the enforcement policy in this guidance address? | premarket notification |
What would not be within the scope of th FDA? | modifications to the indications or functionality that could create such undue risk or that could affect the physiological parameter measurement algorithm |
What would not be within the scope of this policy? | modifications to add new indications or device software functions |
What is a distinct purpose of the product? | function |
What is a “device software function”? | a software function that meets the definition of a device under section 201(h) of the FD&C Act |
What is the 21 CFR 801.5? | describes a number of reasons why directions for use may be inadequate |
What is the purpose of the information on the device? | Information on use conditions |
What should the manufacturer consider in Section III.A? | hardware or softwar |
What is a common reason for device hardware or software architecture modifications? | may warrant accompanying non-device22 and device hardware or software architecture modifications |
What does not affect the physiological parameter measurement algorithm? | such a change would generally be within the scope of this policy |
What do constituent parts of a combination product retain after they are combined? | regulatory status |
What is the Collateral Standard for Electromagnetic Disturbances? | Electromagnetic Disturbances |
What is the FDA's guidance on Medical Image Communications Devices? | Medical Image Communications Devices |
What is the Collateral Standard for? | Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment |
What is the AIM 7351731 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers? | AIM 7351731 |
What is the part 5-1 of IEC 81001-5-1 for? | Security |
What is effective cybersecurity necessary to ensure? | the safety and functionality of such devices |
What is the CGMP requirement of the QS regulation? | good manufacturing practice |
What did FDA want to incorporate by reference? | 2016 edition of the International Organization for Standardization (ISO) 13485 |
What is the name of the part of the proposed rule that specifies the requirements for quality management systems for Medical devices? | part 820 |
What is the FDA's role in Medical Device Cybersecurity? | The FDA’s Role in Medical Device Cybersecurity |
What may manufacturers meet under a streamlined approach? | drug CGMPs and device quality system QS regulation |
What is the name of the document that the FDA issued on July 1, 2020? | Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking |
What is the name of the U.S. Department of Health and Human Services Center for Devices and Radiological Health Center for Biologics Evaluation and Research? | OCOD |
What is the name of the office that FDA is in charge of approving comments to the document? | 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852 |
What is the OCOD? | Office of Communication, Outreach, and Development |
What is the Policy Answer: Compliance Policy for GUDID Submission Requirements for Class I Devices? | null |
What are the Class III, LS/LS, and Class II Non-Sterile Devices Manufactured and Labeled Prior to the Established Direct Mark Compliance Date That Remain in Inventory? | Class III, LS/LS, and Class II Non-Sterile Devices |
What does the guidance not establish any rights for? | any person |
What is FDA's unique device identification system designed to adequately identify? | devices through distribution and use |
What is Section 519(f) of the Federal Food, Drug, and Cosmetic Act? | UDI system regulations |
What can a labeler of a class I device determine? | whether its device is within the scope of that compliance policy |
What is the classification of CADe devices? | 21 CFR 892.2050 |
What is the procurement controls of the CGMP? | 21 CFR 820.50 |
What do the terms "you" and "your" refer to in this guidance document? | the labeler |
What is the FDA determined is a less burdensome policy that is consistent with public health? | this approach |
What is the guidance subject to comment in accordance with? | the Agency’s good guidance practices |
What should be viewed as recommendations? | FDA guidance documents |
What is the name of the rule that the FDA published on September 24, 2013? | UDI system |
What is the range of compliance dates for the UDI Rule? | September 24, 2014, to September 24, 2020 |
What is the UDI Rule also required that data pertaining to the key characteristics of each device required to bear a UDI be submitted to? | FDA’s GUDID |
What did FDA align the compliance date for standard date format requirements with? | compliance date by which a device must bear a UDI on its label and packages |
What does the UDI system seek to improve? | the identification of medical devices |
What is the UDI policy regarding? | Compliance Dates for Class I and Unclassified Devices |
What is the focus of design control discussion in this guidance? | the information required to demonstrate that the final combination product achieves its identified performance |
What did the prior versions of this guidance reflect? | our belief that it was important to continue focusing our resources on addressing UDI implementation issues and data quality for higher risk devices |
What is the lowest risk of UDI devices? | class I devices |
What is the UPC used for? | a barcode |
What is the public benefit of GUDID submission for consumer health products? | public health benefit |
What does FDA not intend to enforce for consumer health products? | GUDID submission requirements |
What was the prior version of the guidance that FDA did not intend to enforce? | direct mark requirements |
What is the UDI Rule for class I devices? | the UDI Rule |
What are typically used in healthcare settings and are often subject to additional regulatory controls? | These devices are typically used in healthcare settings |
What is the purpose of the submission of UDI data into GUDID? | to evaluate and improve device safety throughout the product lifecycle |
What did FDA say in the 2020 UDI Compliance Policy Guidance? | we did not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and unclassified devices, other than I/LS/LS devices |
What are some of the data needed to make such design verification and validation demonstrations? | bench data, preclinical/clinical testing data, and human factors (HF) studies |
What does 21 CFR 830.300 require for class I and unclassified devices? | GUDID submission requirements |
What is the name of the device that is manufactured and labeled before the labeler has implemented direct marking? | finished devices |
What can entail different design changes and design validations than those made in order to add a required UDI direct mark to future lots of the device? | remediating existing devices in inventory |
What may be used to facilitate recalls and medical device reporting, in analysis of premarket approval application (PMA) annual reports, and for other FDA processes? | GUDID data |
What is the tail of the 85 FR 39477? | tail |
What is the compliance date for class I and unclassified devices? | 21 CFR 801.20 |
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