Medical Devices Applications and Approvals

**Overview**
This data package contains all (510(k)) submissions for medical devices, reporting status of post approval studies, Premarket approval (PMA) applications. it lists also all national and international standards recognized by FDA.

**Description**
This data package contains all (510(k)) submissions for medical devices reviewed by FDA’s Center for Devices and Radiological Health (CDRH),  reporting status of post-approval studies (PAS) studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants, database of Premarket approval (PMA) related to the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices it lists also national and international standards recognized by FDA which manufacturers can declare conformity to.

**Benefits**
- Access to medical devices various fda applications.
- access to fda premarket approval data.
- access to updated list of standards recognized by fda.

**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](https://www.johnsnowlabs.com/marketplace/) on John Snow Labs website. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.

**Included Datasets**
- [FDA Devices Premarket Approval Summary Review Memos](https://www.johnsnowlabs.com/marketplace/fda-devices-premarket-approval-summary-review-memos)
- Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes includes 180-day supplements which are requested for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report
- [FDA Medical Device 510k Clearances](https://www.johnsnowlabs.com/marketplace/fda-medical-device-510k-clearances)
- The Food and Drug Administration (FDA) Medical Device 510k Clearances dataset lists all (510(k)) submissions for medical devices. These are reviewed by FDA’s Center for Devices and Radiological Health (CDRH), specifically, by the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological Health (OIR). 510(k) submissions are reviewed by ODE and OIR staff, including biomedical engineers, physicians, microbiologists, chemists, and other scientific professionals.
- [FDA Post Approval Studies Database](https://www.johnsnowlabs.com/marketplace/fda-post-approval-studies-database)
- The Post-Approval Studies (PAS) Database identifies the reporting status of PAS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
- [FDA Premarket Approval Database](https://www.johnsnowlabs.com/marketplace/fda-premarket-approval-database)
- This dataset includes the Premarket Approval (PMA) data which is the Food and Drug Administration (FDA) process of scientific and regulatory review to assess the safety and effectiveness of Class III medical devices. These devices support human life and prevent impairment of human health. Due to the level of risk associated with Class III devices, general and special controls are insufficient to assure the safety of these devices and require a PMA application to obtain marketing clearance.
- [FDA Recognized Consensus Standards](https://www.johnsnowlabs.com/marketplace/fda-recognized-consensus-standards)
- FDA Recognized Consensus Standards database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission.

**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.

**Need Help?**
If you have questions about our products, contact us at [[e-mail]](mailto:[e-mail]).

搜集汇总

背景与挑战

背景概述

该数据集汇总了FDA对医疗设备的510(k)提交、上市后研究状态、PMA申请及认可标准的审批信息，适用于个人和研究用途，商业使用需订阅John Snow Labs数据服务。