Medical Devices Applications and Approvals

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.

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1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

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.

• If you have questions about our products, contact us at info@johnsnowlabs.com .

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.