Skip to content

Commit c687dcb

Browse files
author
beardedfinch
committed
Updated more content componetns.
1 parent ee8724d commit c687dcb

File tree

15 files changed

+539
-433
lines changed

15 files changed

+539
-433
lines changed

src/components/Hero/index.jsx

Lines changed: 1 addition & 1 deletion
Original file line numberDiff line numberDiff line change
@@ -39,7 +39,7 @@ const Hero = (props: tPROPS) => {
3939
} = props
4040

4141
const heroCx = cx({
42-
'flex-box overflow-hidden relative dir-column': true,
42+
'flex-box relative dir-column': true,
4343
'bg-gray': type !== 'dataset' && type !== 'endpoint',
4444
'bg-primary': type === 'dataset'
4545
})
Lines changed: 60 additions & 57 deletions
Original file line numberDiff line numberDiff line change
@@ -1,57 +1,60 @@
1-
- "## About device 510(k)"
2-
- "The premarket notification dataset contains details about specific products and the original sponsors of premarket notification applications. It also contains administrative and tracking information about the applications and receipt and decision dates."
3-
- "A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found substantially equivalent through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the “predicate.”"
4-
- "For additional information, see [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm)."
5-
- "### How to search this endpoint"
6-
- "Make API calls to `https://api.fda.gov/device/510k.json` using search parameters for fields specific to the device recalls endpoint."
7-
- queryExplorer: advisoryCommittee
8-
- queryExplorer: regulationNumber
9-
- queryExplorer: topCountryCodes
10-
- "## Data reference"
11-
- "### Downloads"
12-
- "downloads"
13-
- "### How records are organized"
14-
- "Example:"
15-
- example: record
16-
- "## Anatomy of a response"
17-
- "This is a simulated openFDA API return for a non-`count` query. It is divided into two high-level sections, `meta` and `results`."
18-
- example: anatomy
19-
- "### Meta"
20-
- "For non-`count` queries, the `meta` section includes a disclaimer, a link to the openFDA data license, and information about the results that follow."
21-
- example: meta
22-
- fields:
23-
- meta.disclaimer
24-
- meta.license
25-
- meta.last_updated
26-
- meta.results.skip
27-
- meta.results.limit
28-
- meta.results.total
29-
- "### Results"
30-
- "For non-`count` queries, the `results` section includes matching adverse event reports returned by the API."
31-
- "## Field-by-field reference"
32-
- fields:
33-
- k_number
34-
- clearance_type
35-
- zip_code
36-
- decision_code
37-
- decision_description
38-
- statement_or_summary
39-
- date_received
40-
- third_party_flag
41-
- state
42-
- address_1
43-
- address_2
44-
- contact
45-
- country_code
46-
- city
47-
- review_advisory_committee
48-
- advisory_committee
49-
- advisory_committee_description
50-
- device_name
51-
- product_code
52-
- postal_code
53-
- applicant
54-
- decision_date
55-
- "## OpenFDA"
56-
- fields:
57-
- openfda
1+
- "## Overview":
2+
- "A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found substantially equivalent through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the “predicate.”"
3+
- "The **openFDA Device 510(k) Clearances API** contains details about specific products and the original sponsors of premarket notification applications. It also contains administrative and tracking information about the applications and receipt and decision dates."
4+
- "For additional information, please visit the FDA's [Premarket Notification 510(k) page](https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm)."
5+
6+
- "#### Key facts":
7+
- ul:
8+
- "**Source of the data:** "
9+
- "**Changes to the source data:** OpenFDA annotates the original records with [special fields](#openfda-fields) and converts the data into JSON, which is a widely used machine readable format."
10+
- "**What time period is covered in this API:** "
11+
- "**How often is the data in this API updated:** "
12+
- "**Date last updated:** 11/17/2017"
13+
14+
- "### Responsible use of the data":
15+
- "Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, **a causal relationship cannot be established between product and reactions listed in a report.** While a suspected relationship *may* exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product."
16+
- "Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. In recent years the FDA has undertaken efforts to increase collection of adverse events. Increases in the total number of adverse events is likely caused by improved reporting."
17+
18+
- "## How to use the API":
19+
- "Getting started with and learning how to use the API is relatively straightforward. Here are some recommended steps:"
20+
- "*1.* If you haven’t already, [read the API Basics page](/getting_started/api_basics/)."
21+
- "*2.* Review the [list of searchable fields](#searchable-fields) available in the drug adverse event dataset."
22+
- "*3.* Try out the Device 510k API using the [interactive examples](#using-the-interactive-chart-to-learn-the-API) and tools below."
23+
- "Then, when you are ready, obtain an API Key. While you don’t need an API Key to try or use the API, we recommend you get one if you are planning to use the API on a regular basis. For more information on API Keys, see the [API Reference page](/getting_started/api_basics/reference/)."
24+
25+
- "### Making a simple API call":
26+
- "You can call the API from a web browser. Simply type a valid API query in your browser’s address bar and press the Enter key."
27+
- "In the example below, we are searching the records in the drug adverse events endpoint for matches with 'cv' in the 'advisory_committee' field. We are requesting to see the first 5 records that match."
28+
- "image=/pages/img/device_clearance_query.png"
29+
30+
- "#### Some key pointers":
31+
- ul:
32+
- "An openFDA API query always begins with the base endpoint, which in this case is: https://api.fda.gov/device/510k.json"
33+
- "Searches have a special syntax: `search=field:term`."
34+
- "Unless otherwise specified, the API will return only one matching record for a search. You can specify the number of records to be returned by using the limit parameter. The maximum limit allowed is 99 for any single API call. If no limit is set, the API will return one matching record."
35+
36+
- "#### Some advanced topics":
37+
- "It is possible to construct very complex queries using the openFDA API. See the [API Basics page](/getting_started/api_basics/) to learn more about all the available query parameters, how to handle quotations, spaces, phrase matches, and groupings, how to search on dates and ranges, and more."
38+
- "Here are a few additional tips just to get you started"
39+
- ul:
40+
- "`search=field:term+AND+field:term`: Search for records that match both terms"
41+
- "`search=field:term+field:term`: Search for records that match either of the two terms"
42+
- "`count=field`: Use the count parameter to count how often a term appears in the dataset"
43+
- "`search=field:term&count=another_field`: Search for matching records. Then within that set of records, count the number of times that the unique values of a field appear. Instead of looking at individual records, you can use the [count] parameter to count how often certain terms (like drug names or patient reactions) appear in the matching set of records."
44+
45+
- "### Example API Queries":
46+
- "To help get you started, we have provided some API query examples below. Use the Run query button to call the API and get back results. You can experiment by editing the example queries in the black text box."
47+
- queryExplorer: advisoryCommittee
48+
- queryExplorer: regulationNumber
49+
- queryExplorer: topCountryCodes
50+
51+
- "### Understanding the API Results":
52+
- "For `search` queries (such as: [https://api.fda.gov/device/510k.json?search=regulation_number:872.6855&limit=1](https://api.fda.gov/device/510k.json?search=regulation_number:872.6855&limit=1)), the `results` section includes matching device 510k records returned by the API."
53+
- "For count queries (such as: [https://api.fda.gov/device/510k.json?count=openfda.fei_number](https://api.fda.gov/device/510k.json?count=openfda.fei_number)), the results section will look something like the following:"
54+
- example: count
55+
56+
- "## Download the dataset":
57+
- "downloads"
58+
59+
- "## Searchable Fields":
60+
- "FieldExplorer"

src/pages/api_endpoints/device/510k/_examples.json

Lines changed: 22 additions & 0 deletions
Original file line numberDiff line numberDiff line change
@@ -126,5 +126,27 @@
126126
"total": 1355
127127
}
128128
}
129+
},
130+
"count": {
131+
"meta": {
132+
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
133+
"terms": "https://open.fda.gov/terms/",
134+
"license": "https://open.fda.gov/license/",
135+
"last_updated": "2017-12-02"
136+
},
137+
"results": [
138+
{
139+
"term": "",
140+
"count": 622
141+
},
142+
{
143+
"term": "3005747797",
144+
"count": 541
145+
},
146+
{
147+
"term": "3010041511",
148+
"count": 475
149+
}
150+
]
129151
}
130152
}
Lines changed: 62 additions & 39 deletions
Original file line numberDiff line numberDiff line change
@@ -1,39 +1,62 @@
1-
- "## About device classification"
2-
- "The U.S. Food and Drug Administration (FDA) regulates medical devices in the United States. Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines, and medical lasers."
3-
- "The Product Classification dataset contains medical device names, their associated product codes, their medical specialty areas (panels) and their classification. The name and product code identify the generic category of a device for FDA. The product code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892."
4-
- "The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device."
5-
- "For additional information, see [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm)."
6-
- "### How to search this endpoint"
7-
- "Make API calls to `https://api.fda.gov/device/classification.json` using search parameters for fields specific to the device classification endpoint."
8-
- queryExplorer: oneDevice
9-
- queryExplorer: nob
10-
- queryExplorer: topFei
11-
- "## Data reference"
12-
- "### Downloads"
13-
- "downloads"
14-
- "## How records are organized"
15-
- example: header
16-
- example: openfda
17-
- "## Results"
18-
- "For non-`count` queries, the `results` section includes matching device classification records returned by the API."
19-
- "## Field-by-field reference"
20-
- fields:
21-
- regulation_number
22-
- life_sustain_support_flag
23-
- definition
24-
- review_code
25-
- submission_type_id
26-
- third_party_flag
27-
- implant_flag
28-
- medical_specialty
29-
- medical_specialty_description
30-
- device_class
31-
- device_name
32-
- product_code
33-
- review_panel
34-
- unclassified_reason
35-
- gmp_exempt_flag
36-
- "### OpenFDA"
37-
- "The `openfda` section of each document is determined by looking at the product_code value."
38-
- fields:
39-
- openfda
1+
- "## Overview":
2+
- "Most medical devices can be classified by finding the matching description of the device in Title 21 of the Code of Federal Regulations (CFR), Parts 862-892."
3+
- "The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device."
4+
- "The **openFDA Device Classification API** contains medical device names, their associated product codes, their medical specialty areas (panels) and their classification. The name and product code identify the generic category of a device for FDA. The product code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892."
5+
- "For additional information, see [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm)."
6+
7+
- "[infographic here]"
8+
9+
- "### Responsible use of the data":
10+
- "Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, **a causal relationship cannot be established between product and reactions listed in a report.** While a suspected relationship *may* exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product."
11+
- "Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. In recent years the FDA has undertaken efforts to increase collection of adverse events. Increases in the total number of adverse events is likely caused by improved reporting."
12+
13+
- "### Disclaimer":
14+
- "This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall. FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. FDA works with industry and our state partners to publish press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the product. Subscribe to this Recall/Safety Alert feed here."
15+
- "Further, FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports."
16+
17+
- "## How to use the API":
18+
- "Getting started with and learning how to use the API is relatively straightforward. Here are some recommended steps:"
19+
- "*1.* If you haven’t already, [read the API Basics page](/getting_started/api_basics/)."
20+
- "*2.* Review the [list of searchable fields](#searchable-fields) available in the drug adverse event dataset."
21+
- "*3.* Try out the Device Classification API using the [interactive examples](#using-the-interactive-chart-to-learn-the-API) and tools below."
22+
- "Then, when you are ready, obtain an API Key. While you don’t need an API Key to try or use the API, we recommend you get one if you are planning to use the API on a regular basis. For more information on API Keys, see the [API Reference page](/getting_started/api_basics/reference/)."
23+
24+
- "### Making a simple API call":
25+
- "You can call the API from a web browser. Simply type a valid API query in your browser’s address bar and press the Enter key."
26+
- "In the example below, we are searching the records in the drug adverse events endpoint for matches with 'NOB' in the 'product_code' field. We are requesting to see the first 5 records that match."
27+
- "image=/pages/img/drug_event_query.png"
28+
29+
- "#### Some key pointers":
30+
- ul:
31+
- "An openFDA API query always begins with the base endpoint, which in this case is: https://api.fda.gov/device/classification.json"
32+
- "Searches have a special syntax: `search=field:term`."
33+
- "Unless otherwise specified, the API will return only one matching record for a search. You can specify the number of records to be returned by using the limit parameter. The maximum limit allowed is 99 for any single API call. If no limit is set, the API will return one matching record."
34+
35+
- "#### Some advanced topics":
36+
- "It is possible to construct very complex queries using the openFDA API. See the [API Basics page](/getting_started/api_basics/) to learn more about all the available query parameters, how to handle quotations, spaces, phrase matches, and groupings, how to search on dates and ranges, and more."
37+
- "Here are a few additional tips just to get you started"
38+
- ul:
39+
- "`search=field:term+AND+field:term`: Search for records that match both terms"
40+
- "`search=field:term+field:term`: Search for records that match either of the two terms"
41+
- "`count=field`: Use the count parameter to count how often a term appears in the dataset"
42+
- "`search=field:term&count=another_field`: Search for matching records. Then within that set of records, count the number of times that the unique values of a field appear. Instead of looking at individual records, you can use the [count] parameter to count how often certain terms (like drug names or patient reactions) appear in the matching set of records."
43+
44+
- "### Example API Queries":
45+
- "To help get you started, we have provided some API query examples below. Use the Run query button to call the API and get back results. You can experiment by editing the example queries in the black text box."
46+
- queryExplorer: oneDevice
47+
- queryExplorer: nob
48+
- queryExplorer: topFei
49+
50+
- "### Explore the API with an interactive chart":
51+
- "Use the interactive chart below to explore the dataset and to learn how you can construct different API queries."
52+
53+
- "### Understanding the API Results":
54+
- "For `search` queries (such as: [https://api.fda.gov/device/classification.json?search=regulation_number:872.6855&limit=1](https://api.fda.gov/device/classification.json?search=regulation_number:872.6855&limit=1)), the `results` section includes matching adverse event reports returned by the API."
55+
- "For count queries (such as: [https://api.fda.gov/device/classification.json?count=openfda.fei_number](https://api.fda.gov/device/classification.json?count=openfda.fei_number)), the results section will look something like the following:"
56+
- example: count
57+
58+
- "## Download the dataset":
59+
- "downloads"
60+
61+
- "## Searchable Fields":
62+
- "FieldExplorer"

0 commit comments

Comments
 (0)