Question stringlengths 13 1.05k ⌀ | Answer stringlengths 2 801 ⌀ |
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What is the compliance date for Finished class I and unclassified devices? | September 24, 2018 |
What is the Compliance Policy for GUDID Submission Requirements for Class I Devices 1? | Compliance Policy for GUDID Submission Requirements for Class I Devices 1. Class I Devices Considered Consumer Health Products |
What does “consumer health products” mean? | 510(k)-exempt class I devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores and that do not fall within one or more of the categories |
What is the policy for 2020 UDI Compliance Policy Guidance? | 85 FR 39477 |
What is a biological product regulated under section 351 of the Public Health Service Act? | a drug or a device |
What is the name of the agency that determines that class I devices are not considered consumer health products? | FDA |
What are er risk devices subject to? | additional regulatory controls |
What is the majority of class I devices exempt from? | the 510(k) premarket notification process |
What is a clinical labora? | a clinical labora |
What is the name of the subpart B of 21 CFR 801.40? | 21 CFR 801.40 |
What is the name of the UDI that a user can use in addition to a UPC? | UDI |
What is the definition of a prescription use? | prescription use |
What is a life-supporting or life-sustaining device defined at 21 CFR 860.3 as? | a device that is “essential to, or that yie Answer: Life-supporting or life-sustaining device” |
What does FDA recommend evaluating to determine if a particular device is life-supporting or life-sustaining? | the device’s intended use |
What is the purpose of reusable vices? | intended for use by healthcare professionals only |
What is the PFS for the PFS, elastomeric plunger, and needle? | the PFS |
What is the term for a device that is intended to be used more than once on or by the same patient? | reusable |
What does an unclassified device generally require? | submission of a 510(k) premarket notification |
How many calendar days are required to submit a GUDID submission under 21 CFR 830.300 for unclassified devices? | 75 calendar days |
What is the direct mark compliance date for LS/LS devices? | September 24, 2015 |
What is the purpose of this provision? | reduce burden associated with the UDI Rule for inventories of finished devices that were manufactured and labeled prior to the applicable compliance date |
What is the name of the guidance that describes the intention to exempt certain Unclassified Medical Devices from Premarket Notification Requirements? | “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements” |
What does the UDI Compliance Policy Guidance state that we do not intend to enforce the GUDID data submission requirements for? | unclassified devices |
What is the name of the document that may be applicable to UDI? | tem/udi-exceptions-alternatives- and-time-extensions |
What do labelers use the new field(s) to document when the field becomes available? | that their devices are subject to such a method |
What is the ompliance date for class I and unclassified devices? | September 24, 2020 |
What is the step of the applicant that considers whether other existing information may be leveraged to 295 support the items in Step 4? | Step 4 |
What is the ark requirements under 21 CFR 801.45 for? | finished class I and unclassified devices |
What is FDA looking for in a method for constructing the UDI? | documented or referenced that method in the DMR |
What is the policy for UDI direct mark requirements under 21 CFR 801.45 for class I and unclassified devices, other than LS/LS devices, remains the same as the policy in the 2020 UDI Compliance Policy Guidance.? | null |
What is the name of the FDA's Office of the Commissioner? | Office of the Commissioner |
What is the name of the office of Communication, Education, and Radiation Programs Division of Small Manufacturers, International, and Consumer Assistance Center for Devices and Radiological Health? | Office of Communication, Education, and Radiation Programs |
What is the name of the veterinary clinic in the US? | HFV-12 |
What is the name of the system that stores data? | Retrieving Data 6 |
What does not create or confer any rights for or on any person and does not operate to bind FDA or the public.? | null |
What is the name of the FDA staff that implements this guidance? | FDA staff |
What is the applicant considering establishing between the previously approved 302 product and the proposed autoinjector? | a bridge |
What is the source data needed for? | the reconstruction and evaluation of the study to determine the safety of food and color additives and safety and effectiveness of new human and animal drugs,3 and medical devices |
What is the name of the guidance that was issued in April 1999? | Electronic Records; Electronic Signatures — Scope and Application |
What does the Agency intend to do with part 11? | interpret the scope of part 11 narrowly and to exercise enforcement discretion with regard to part 11 requirements for validation, audit trails, record retention, and record copying |
What does the word should mean in Agency guidances? | something is suggested or recommended, but not required |
What must be the same fundamental elements of data quality as paper records? | attributable, legible, contemporaneous, original,5 and accurate |
What did FDA say was acceptable under certain circumstances? | electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper |
What was the final draft guidance for industry entitled? | Computerized Systems Used in Clinical Trials |
What is allowing original documents to be replaced by copies? | copies |
What does this guidance apply to computerized systems that capture analytical results of tests conducted during a clinical trial? | 21 CFR 312.62(b) and 812.140(b) |
What is an example of a computerized system that can be used to record an ECG reading? | an ECG reading |
What is the purpose of the HF validation study? | it will be challenging to bridge the applications |
What is IDE? | Investigational Device Exemption |
What should the computerized systems do? | (1) to prevent errors in data creation, modification, maintenance, archiving, retrieval, or transmission |
What should be maintained either on-site or be remotely accessible through electronic files as part of the specific study records? | SOPs |
What is the source document when original observations are entered directly into a computerized system? | the electronic record |
What is the name of the system that a data is entered directly into a remote computerized system? | a remote computerized system |
What must be limited to authorized individuals? | Limited Access Access |
What should individuals work only under? | their own password or other access key and not share these with others |
What should someone do when they leave a workstation? | log off the system |
What does the use of audit trails help to ensure? | only authorized additions, deletions, or alterations of information in the electronic record have occurred |
What should be determined based on a justified and documented risk assessment? | The need for audit trails |
What did the applicant believe it could leverage because of the previously approved autoinjector design? | design verification data unrelated to the drug being injected |
What should describe when, by whom, and the reason changes were made to electronic record activities? | Audit trails or other security methods |
Who should be notified if a system date or time discrepancy is detected? | authorized personnel |
What do systems recommend that dates and times include? | year, month, day, hour, and minute |
What is better for systems that span different time zones? | time stamps |
What should be put in place to prevent the altering, browsing, querying, or reporting of data via external software applications that do not enter through the protective system software.? | null |
What should be kept in the study documentation? | that record |
What can be used to permit repopulation of information specific to the subject? | programming features |
What should be designed in a way that retrieved data regarding each individual subject in a study is attributable to that subject? | computerized system |
What is not necessary to reprocess data from a study that can be fully reconstructed from available documentation? | actual application software, operating systems, and software development tools |
What should be designed to protect against data loss? | sufficient backup and recovery procedures |
What is the applicant planning to provide design validation confirming? | that the autoinjector 323 performance specifications are adequate |
Where should records be stored? | at a secure location |
What should be documented for changes that exceed previously established operational limits or design specifications? | Changes that exceed previously established operational limits or design specifications |
What should be provided to individuals in the specific operations with regard to computerized systems that they are to perform? | Training |
What is a process that captures details such as additions, deletions, or alterations of information in an electronic record? | Audit Trail |
What is an example of a computerized system? | user manual |
What is an electronic record? | any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained |
What is allowing original documents and the original data recorded on those documents to be replaced by copies? | copies |
What is the purpose of a Transmit? | to transfer data within or Answer: Answer: at the pharmacy, at the laboratories, and at medico-technical departments involved in a clinical trial |
What is the name of the guideline for the Monitoring of Clinical Investigations? | Guideline for the Monitoring of Clinical Investigations |
What should the SOPs include? | System setup/installation |
What is the OEB? | lung computed tomography system, computer-aided detection |
What is the name of the document that contains nonbinding recommendations Draft—Not for Implementation? | 21 CFR 820.30(g) & (j) |
What is the name of the system maintenance? | System decommissioning |
What is the name of the agency that oversees the use of computerized systems in clinical trials? | Office of the Commissioner |
What is the phone number for the Drug Information Center for Drug Evaluation and Research? | 301-827-4573 |
What is the name of the veterinary center that is located in the US? | HFV-12 Center for Veterinary Medicine |
What is the name of the office that oversees the Food and Drug Administration? | Office of the Commissioner |
What does the guidance represent? | the Food and Drug Administration's (FDA's) current thinking on this topic |
What is the FDA's staff responsible for implementing? | this guidance |
What are CROs? | data management centers |
What is the name of the guidance dated April 1999? | Part 11 |
What is the purpose of the local adverse event data? | assess how the new interface may affect pain on delivery |
What is the ICH E6 Good Clinical Practice consol? | Answer: Answer: ICH E6 Good Clinical Practice consol |
What are the terms used in FDA guidance to describe the same information? | source documents |
What does ICH stand for? | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use |
What is an increasing use of computerized systems in clinical trials to generate and maintain source data and source documentation on each clinical trial subject? | computerized systems |
What is the requirement for FDA's acceptance of data from clinical trials for decision-making purposes? | FDA's ability to verify the quality and integrity of the data during FDA on-site inspections and audits |
What did FDA and industry want to do with part 11? | proposeing additional rulemaking, and exercising enforcement discretion regarding enforcement of certain part 11 requirements |
What is the final version of the draft guidance for industry entitled Electronic Records; Electronic Signatures – Scope and Application (Scope and Application Guidance) dated August 2003.? | null |
What is the approach outlined in the Scope and Application Guidance? | The approach outlined in the Scope and Application Guidance |
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