This data package contains the lists of Humanitarian Device Exemptions delivered by the FDA (Food and Drug Administration). Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.
This data package contains the access to Humanitarian Device Exemption provided by the FDA for Humanitarian Use Device (HUD). Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer's research and development costs could exceed its market returns for diseases or conditions affecting small patient populations.
License Information
The use of John Snow Labs datasets is free for personal and research purposes. For commercial use please subscribe to the Data Library on AWS. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.
Metadata
Description
Value
Data Package Complexity
Simple
Available Enrichments
N/A
Keywords
Humanitarian Device, CDRH, Device Exemptions, CDRHEstablishment US Agent, FDA Medical Device
Other Titles
FDA Humanitarian Device Exemptions, US Humanitarian Device Exemptions
Included Datasets
Center for Devices and Radiological Health Device Exemptions
The Center for Devices and Radiological Health (CDRH) Humanitarian Device Exemptions dataset includes the list of Humanitarian Device Exemptions delivered by the Food and Drug Administration (FDA). A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.
Humanitarian Device Exemption
This dataset includes the list of Humanitarian Device Exemptions delivered by the Food and Drug Administration (FDA).
A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer's research and development costs could exceed its market returns for diseases or conditions affecting small patient populations.
Data Engineering Overview
We deliver high-quality data
Each dataset goes through 3 levels of quality review
2 Manual reviews are done by domain experts
Then, an automated set of 60+ validations enforces every datum matches metadata & defined constraints
Data is normalized into one unified type system
All dates, unites, codes, currencies look the same
All null values are normalized to the same value
All dataset and field names are SQL and Hive compliant
Data and Metadata
Data is available in both CSV and Apache Parquet format, optimized for high read performance on distributed Hadoop, Spark & MPP clusters
Metadata is provided in the open Frictionless Data standard, and its every field is normalized & validated
Data Updates
Data updates support replace-on-update: outdated foreign keys are deprecated, not deleted
Our data is curated and enriched by domain experts
Each dataset is manually curated by our team of doctors, pharmacists, public health & medical billing experts:
Field names, descriptions, and normalized values are chosen by people who actually understand their meaning
Healthcare & life science experts add categories, search keywords, descriptions and more to each dataset
Both manual and automated data enrichment supported for clinical codes, providers, drugs, and geo-locations
The data is always kept up to date – even when the source requires manual effort to get updates
Support for data subscribers is provided directly by the domain experts who curated the data sets
Every data source’s license is manually verified to allow for royalty-free commercial use and redistribution.
John Snow Labs, an AI and NLP for healthcare company, provides state-of-the-art software, models, and data to help healthcare and life science organizations build, deploy, and operate AI projects.
AWS Marketplace now accepts line of credit payments through the PNC Vendor Finance program. This program is available to select AWS customers in the US, excluding NV, NC, ND, TN, & VT.
This listing uses a single pricing dimension: Product Access (Units). It grants you access to the product at no cost. There are no tiers, instance sizes, or usage-based add-ons to compare. Pricing does not scale with usage or quantity. You subscribe once to gain access to the product's healthcare AI capabilities. Because the product is free, there is one flat access option rather than a range of paid options.
Top-of-mind questions for buyers
What does the Product Access (Units) dimension grant me?
It grants you subscriber access to the product at no cost. One unit represents your access grant to the healthcare AI capabilities. There are no per-user, per-host, or usage-based counts to track. You subscribe once and gain access without variable metering.
Will my cost change as I use the product more or add more users?
No. This listing is free, with a single flat access dimension. Your cost does not scale with usage, data volume, user count, or resources. There are no tiers or included-amount thresholds that trigger extra charges. Access remains at no cost regardless of how much you use it.
What capabilities do I get access to through this free subscription?
You gain access to John Snow Labs healthcare AI capabilities. These include medical language models, clinical text de-identification, data harmonization, and secondary-use data tools. The software is designed to run inside your own secure environment. Note that AWS infrastructure charges for hosting may still apply separately.
Tell us how we can improve this page, or report an issue with this product.
Give us feedbackReport a problem with this product or seller
Legal
Vendor terms and conditions
Upon subscribing to this product, you must acknowledge and agree to the terms and conditions outlined in the vendor's End User License Agreement (EULA).
Content disclaimer
Vendors are responsible for their product descriptions and other product content. AWS does not warrant that vendors' product descriptions or other product content are accurate, complete, reliable, current, or error-free.
AvaTax for Communications (AFC) is a purpose-built tax engine that calculates communications taxes and fees, including USF, E911, TRS, and tiered pricing, in real time across more than 60,000 North American jurisdictions, going beyond standard sales tax to handle the industry's most complex tax scenarios.
Kriv AI authors a Predetermined Change Control Plan (PCCP) for AI/ML-enabled medical devices seeking FDA clearance via 510(k) or De Novo. Aligned with FDA Dec 2024 final guidance "Marketing Submission Recommendations for a PCCP for AI-Enabled Device Software Functions." Scope: Device Description + Modification Description + Modification Protocol (data management, re-training, V&V, labeling) + Impact Assessment + Algorithm Change Protocol + ISO 14971 clinical risk + cybersecurity premarket (Sep 2023 + Section 524B PATCH Act + SBOM) + RWPM plan + GMLP 10-principle gap analysis + Q-Sub briefing (Enterprise). Three tiers: $65K Foundation (6 wks, 1 device) / $125K Standard (8 wks, +GMLP +cybersecurity +RWPM) / $225K Enterprise (12 wks, +multi-device +Q-Sub +DHCoE +post-market +TAP). +$25K per additional pre-specified modification.
VizBPP is an integrated Business Personal Property tax management solution what can be used by Taxpayers to submit related business personal property tax statements, the submitted data then will be processed by Appraiser with the involvement of Supervisor/Tax Manager to assess final property values and taxes.
Enable Eligibility Request and Response using FHIR Resources. No more need for X12 EDI 270/271. HiPaaS process has option to convert FHIR request and response to EDI OR generate the request and Response from payer data to FHIR directly.