indications for use | Content of a 510(k) | FDA

Keyword	CPC	PCC	Volume	Score	Length of keyword
indications for use	0.52	0.5	8702	59	19
indications	0.45	0.9	9575	53	11
for	1.12	0.5	8480	22	3
use	0.04	0.6	2931	90	3

Keyword	CPC	PCC	Volume	Score
indications for use	1.96	0.1	7838	84
indications for use meaning	0.29	1	1728	23
indications for use fda	1.17	0.7	3909	61
indications for use vs intended use	0.11	0.2	1336	53
indications for use statement	0.38	0.7	2841	22
indications for use medical device	1.51	0.5	7427	18
indications for use examples	0.64	0.3	4606	73
indications for use of chest drain clamps	1.78	0.7	6990	11
indications for use of pulse oximetry nrp	1.35	0.4	3925	91
indications for use of aspirin	0.65	0.3	4900	22
indications for use of farxiga	1.49	0.5	4197	34
indications for use vs intended use fda	0.3	1	5216	86
topamax indications for use	0.62	0.2	1208	2
nystatin powder indications for use	1.93	0.7	9744	21
indications for tamsulosin use	0.57	0.7	6096	33
wound cleansing solutions indications for use	0.47	0.2	1019	69
silver dressings indications for use	1.13	0.6	5710	16
duloxetine indications for use	0.89	0.4	3546	50
dexcom g7 indications for use	1.7	0.3	959	40

Search Results related to indications for use on Search Engine

Content of a 510(k) | FDA - U.S. Food and Drug Administration
fda.gov

https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k

WEBWe recommend that you use the Indications for Use form. The statement should include specific indications, clinical settings, define the target population, anatomical sites, etc.

DA: 30 PA: 89 MOZ Rank: 50

General/Specific Intended Use - Guidance for Industry | FDA
fda.gov

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/generalspecific-intended-use-guidance-industry

WEBThis guidance 1 document identifies the general principles that will be considered by the Food and Drug Administration (FDA) in determining when a specific indication for use is reasonably ...

DA: 30 PA: 97 MOZ Rank: 39

How to Determine if Your Product is a Medical Device | FDA
fda.gov

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

WEBTo determine if your product meets the definition of a medical device, you should define the intended use and indications for use of your product. Once you have defined the intended use and...

DA: 24 PA: 99 MOZ Rank: 84

The Difference Between Intended Use and Indications of Use …
greenlight.guru

https://www.greenlight.guru/blog/intended-use-and-indications-of-use

WEBDec 2, 2022 · In a nutshell, the definitions for intended use and indications are as follows: Intended use is what you claim on your label that the device does. It’s the purpose of your device. Indications for use are the circumstances or conditions under which the device will be used. These are the reasons you would use the device.

DA: 91 PA: 78 MOZ Rank: 84

Key Considerations In "Intended Use" And "Indications For Use
meddeviceonline.com

https://www.meddeviceonline.com/doc/key-considerations-in-intended-use-and-indications-for-use-statements-for-medical-devices-0001

WEBDec 14, 2023 · So, indications for use would specify the disease, condition, injury, or illness the device will prevent, diagnose, or treat, along with the circumstances surrounding the device’s use. Indications also look at who will use the device, where, and for how long.

DA: 19 PA: 57 MOZ Rank: 27

CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=814.20

WEBDec 22, 2023 · (i) Indications for use. A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which...

DA: 82 PA: 7 MOZ Rank: 82

Indications and Usage Section - U.S. Food and Drug …
fda.gov

https://www.fda.gov/files/drugs/published/Presentation--REdI---Indications-and-Usage-Section.pdf

WEBI&U “section must state drug is indicated for” treatment, relief, prevention, mitigation, cure, or diagnosis of a recognized. disease/condition or manifestation of a recognized. disease ...

DA: 42 PA: 19 MOZ Rank: 13

An FDA Guide on Indications for Use and Device Reporting of …
sciencedirect.com

https://www.sciencedirect.com/science/article/pii/S1546144023004234

WEBAug 1, 2023 · indications for use. patient population. pediatrics. Introduction: Artificial Intelligence as a Device in Radiology. Devices incorporating artificial intelligence (AI) and machine learning can be found in many areas of medicine, and radiology has been a pioneer in adopting AI-enabled devices into the clinic.

DA: 52 PA: 71 MOZ Rank: 41

Understanding Intended Use vs. Indications of Use | RegDesk
regdesk.co

https://www.regdesk.co/understanding-intended-use-vs-indications-of-use/

WEBOct 11, 2023 · An indication of use in terms of medical devices specifies the intended purpose and conditions for which a device is designed. It outlines the functions, target population, and specific medical applications the device is meant for.

DA: 45 PA: 71 MOZ Rank: 4

MDR clinical evaluation planning - intended purpose, indications
bsigroup.com

https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/mdr-clinical-evaluation-planning-intended-purpose-indications-contraindications/

WEBJan 5, 2022 · 'indication’, ‘indication for use’: refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device. It should be distinguished from ‘intended purpose/intended use’, which describes the effect of a device.

DA: 84 PA: 79 MOZ Rank: 52