Question stringlengths 13 1.05k ⌀ | Answer stringlengths 2 801 ⌀ |
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What should be consistent with the general approach used for evaluation of PI content? | FDA’s assessment of the prescription drug use-related software-related information |
What does the placement and extent of information describing 217 software functions in the PI depend on? | the evidence submitted by the sponsor and whether the 218 software functions are device-connected |
What may demonstrate that a combination product 229 with device-connected prescription results in a meaningful improvement in a clinical outcome? | evidence |
What is a dose-tracking app? | a meaningful change in a clinical outcome or validated surrogate endpoint |
What is an acceptable non-fully crossed study design? | non-fully crossed study designs |
What should be reviewed and approved by FDA as is required for 24 See 21 CFR 314.126(b)? | null |
What is the following 255 Answer: In many cases, a sponsor may develop prescription drug use-related software that relies on data 252 directly transferred from the device constituent part of a drug sponsor’s combination product without generating evidence showing that use of the prescription drug use-related software 254 confers additional clinical benefit beyond that of the combination product alone.? | null |
What is a sponsor's proposal to include in the PI about the inhaler's ability to track inhaler events? | a brief 261 description |
What is a sponsor 266 responsible for? | develop an autoinjector that captures when the autoinjector is used and transfers that 267 information to a mobile app |
What does the prescription drug use-related software relies on in these examples? | data directly 272 transferred from the device constituent part of the combination product |
What should the PI provide in 277? | a brief description 278 of the device constituent part and the associated software function(s) |
What may be submitted in an annual report if the information is consistent with 21 CFR 314.70(d)(2).? | null |
What would the end-user output from prescription drug use-related software generally be considered? | promotional labeling |
What must be submitted to FDA by the applicant at the time of initial dissemination? | Form FDA 2253 (Transmittal of Advertisements and Promotional Labeling 296 for Drugs and Biologics for Human Use) |
What is the voluntary opportunity to submit promotional communications to FDA? | 21 CFR 202.1(j)(4) |
What is a key factor for obtaining consistent and convincing scientific evidence? | specification of the statistical analysis |
Who will CDRH consult with regarding the representations about the drug within the prescription drug use-related software? | CDER or CBER |
What must applicants submit at the time of initial dissemination? | Form FDA 2253 |
What is the case of cleared devices? | could significantly affect the safety or effectiveness of the device |
What is the requirement for a new or modified device constituent part or component of a combination product? | a new or modified device constituent part or component of a combination product |
What does Example A's network-connected mobile app display on a screen via the mobile app? | data 325 |
What is the data showing over time displayed on? | ingestion over time |
What are the five software functions considered? | device-connected software functions 340 |
What is the end-user output of the web-application? | display of ingestion data |
What does the Example B mobile app transfer the self-reported information to? | a cloud-based application for their health 354 care practitioner to review on a web-application |
What is the name of the software function that allows the display of symptom 360 incidence and severity data via the mobile app display screen? | software |
What is the rating scale used for? | Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: the selected case sample size, o statistical and clinical justification of the selected number of readers |
What is the end-user output of the web-application? | display of self-reported information |
What is the example C intended to be used with? | a combination product |
What does the 380 patient mobile app transfer the self-reported 382 data to? | the health care practitioner web-application |
What is the web-application used to aggregate? | self- 384 reported symptoms data and the data collected from the device constituent part of the 385 combination product |
What is the transfer of notifications and alerts to a health care 394 practitioner web-application? | the transfer of notifications and alerts |
What is the transfer of patient- 398 self reported data to the health care practitioner web-application? | transfer of patient- 398 self reported data |
What are the four end-user outputs? | the web-application’s display of data |
What is the patient mobile app's display of data collected from the device constituent part of the combination 414 product? | patient mobile 413 app |
What is the software included in the mobile app? | dose calculator function |
What is the output determined to be for the prescription drug? | promotional labeling |
What is the details of the scoring technique used? | Section IV.E. Scoring |
What does the changes do that do not affect the clinical use of the device? | do 435 not affect the clinical use of the device |
What does the mobile app mention? | sponsor’s drug name |
What does the welcome video include information on? | the safety and effectiveness of the 447 insulin product but does not provide information on the dose calculator |
What is the most recent version of a guidance? | FDA guidance web page |
What must be submitted on Form FDA 2253 at the time of 452 initial dissemination? | revised output |
What is the name of the end user that the prescription drug use-related software presents to the end user? | a patient, caregiver, or health care practitioner |
What does software function 468 rely on? | data directly transferred from the device constituent part of a sponsor’s combination 469 product |
What is the name of the document that provides guidance for industry and Food and Drug Administration Staff? | Guidance for Industry and Food and Drug Administration Staff Document |
What is the docket number of FDA-2018-D-1774? | FDA-2018-D-1774 |
What is the document number of the guidance? | 16016 |
What is the name of the study that is the subject of the book? | Evaluation Paradigm and Study Endpoints |
What is appropriately representative of the intended use population? | study populations |
What does the guidance not establish any rights for? | any pers |
What is the purpose of this guidance document? | to provide recommendations for information to Answer: The purpose of this guidance document is to provide recommendations for information to Answer: Answer: This guidance document addresses labeling considerations for devices containing lubricious coatings used in the vasculature |
What is the name of the premarket notification submission that is submitted in the labeling of a device? | 510(k)s |
What is the name of the coating that devices often have to reduce friction between devices? | polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone |
What are hydrophilic and hydrophobic coated devices used for? | more than 20 yea |
What does the FDA believe may separate from intravascular devices in some circumstances? | coating |
What is the name of the document that describes the separation of hydrophilic and/or hydrophobic coatings from medical devices? | Medical Device Reports |
What has the FDA evaluated in relation to ducers? | peer-reviewed medical literature1,2,3,4 and physician surveys |
What did some patients require to mitigate the consequences of coating fragments? | surgical intervention |
What is the purpose of the communication? | to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate from medical devices |
What is the purpose of study endpoints? | to demonstrate that your CADe device is effective |
What was the name of the device used to treat supraclinoid aneurysms? | Pipeline Embolization Device |
What is the Human Pathology, 2015? | 46(3): 488-489 |
What is the FDA not suggesting is associated with higher risks than others? | any specific manufacturer or brand of these devices |
What is the FDA guidance titled? | Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests |
What is the name of the guidance document that provides labeling recommendations for intravascular catheters and wires? | Labeling recommendations for both Class III and Class II devices |
What are the devices in the scope of this guidance? | a variety of devices and product codes |
What is the Regulation Number of the DQO Catheter? | Regulation Number DQO Catheter, Intravascular, Diagnostic |
What is the term for the Term Greater Than 30 Days LJT Port & Catheter? | Term |
What is the current product code of the device for Acute Ischemic Stroke Treatment? | 870.133 |
What is the receiver operating characteristic (FROC) curve? | free-response receiver operating characteristic (FROC) curve |
What is the name of the table that shows the classification of Class III devices? | Table 2 |
What is PTCA? | nal Coronary Angioplasty |
What are the recommendations based on? | known safety issues |
What is the name of the FDA guidance on deciding when to submit a 510(k) for a change to an existing device? | “Deciding When to Submit a 510(k) for a Change to an Existing Device,”9 |
What should the device description prominently note the presence of? | the coating |
What should all indications for use described in the labeling be supported by? | information in the premarket submission |
What are many devices designed, labeled, and indicated for? | specific uses |
What is the name of the document that should be included in the labeling of a device? | precaution statement |
What should include information that will guide the user in a clinical setting? | The preparation steps |
What should you include if you believe one or more of the considerations are not applicable to your device? | any additional warnings and precautions not identified below that you determine are necessary to promote the safe use of the device based on your device design and intended use |
What is the LROC curve? | sensitivity (Se) and specificity (Sp) |
What is a warning against reuse or re-sterilization of the device? | reuse or re-sterilization of the device |
What is the recommended duration for pre-conditioning? | appropriate duration |
What should a user do if they have a known incompatibility with specific media or solvents? | specification of any known incompatibility |
What should the labeling instruct and warn users to do? | use caution when manipulating, advancing and/or withdrawing these devices |
What may result in adverse events (section D below) requiring additional intervention? | coating material remaining in the vasculature |
What is important to the user to be informed of? | key device dimensions |
What is the term for aqueous media in which a coating swells? | saline |
What should be presented in a format consistent with 21 CFR 801.18? | The date |
What should be avoided during preparation or device use that could result in misuse scenarios or coating damage be identified? | Any practices that should be avoided during preparation or device use |
What should the labeling instruct the user of? | appropriate shape configurations and shaping |
What is the probability that a test is negative for a population of normal patients? | Sp |
What should the user do if the device should not move freely? | exercise caution when removing the device and/or other components as a unit |
What may depend on the specific design? | specific adverse events |
What are some of the adverse events that may occur at the access site? | Sterile inflammation or granulomas |
When was the original document issued? | September 25, 2013 |
What is the name of the facility that Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research is located in? | U.S. Department of Health and Human Services |
What is the OCOD? | Office of Communication, Outreach, and Development |
What does FDA intend to exercise for software functions? | enforcement discretion |
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