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Related Concept Videos

Health Information Technology and Healthcare Information System01:30

Health Information Technology and Healthcare Information System

Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
Methods of Documentation VII: EMR01:30

Methods of Documentation VII: EMR

Electronic Medical Records (EMRs) primarily center around electronically documenting patients' health information within a single healthcare organization or practice. They contain essential clinical data related to a patient's medical history, diagnoses, medications, treatment plans, lab results, and other pertinent information relevant to the specific encounter or episode of care. EMRs are designed to streamline documentation and workflow processes within individual healthcare settings,...
Data Reporting and Recording01:24

Data Reporting and Recording

Reporting and recording are crucial in data documentation. The timely, thorough, and accurate documentation of facts is essential when recording patient data. Failure to record findings during an assessment or interpretation of a problem will result in loss of information and make the patient document unreliable. The reader is left with general impressions if the information is not specific. A recording is documenting data of the individual's health information in a traceable, secure, and...
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Parenteral Drug Delivery Systems: Injectables, Implants, and Infusion Devices01:28

Parenteral Drug Delivery Systems: Injectables, Implants, and Infusion Devices

Parenteral drug delivery systems play a crucial role in modern therapeutics by enabling the direct administration of drugs into the systemic circulation, bypassing the gastrointestinal tract. These systems are particularly valuable for poorly absorbed oral medications that are unstable in the digestive environment or require rapid onset or sustained therapeutic levels. Delivery is achieved through intravenous, intramuscular, or subcutaneous routes, each selected based on the drug's properties...

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Related Experiment Video

Updated: Jun 4, 2026

Blood Flow Imaging with Ultrafast Doppler
05:57

Blood Flow Imaging with Ultrafast Doppler

Published on: October 14, 2020

Medical devices; Medical Device Data Systems. Final rule.

    Federal Register
    |March 1, 2011
    PubMed
    Summary

    The Food and Drug Administration (FDA) reclassified Medical Device Data Systems (MDDSs) from class III to class I, simplifying regulatory oversight. This change exempts MDDSs from premarket notification, streamlining access to these essential data management tools.

    Area of Science:

    • Medical Device Regulation
    • Health Informatics
    • Biomedical Engineering

    Background:

    • Medical Device Data Systems (MDDSs) were previously classified under class III, requiring premarket approval.
    • This classification posed significant regulatory hurdles for MDDSs.

    Purpose of the Study:

    • To reclassify MDDSs from class III to class I.
    • To reduce regulatory burden for MDDSs while ensuring safety and effectiveness.

    Main Methods:

    • The Food and Drug Administration (FDA) initiated a final rule-making process.
    • Reclassification based on the intended use and risk profile of MDDSs.

    Main Results:

    • MDDSs are reclassified from class III (premarket approval) to class I (general controls).

    Related Experiment Videos

    Last Updated: Jun 4, 2026

    Blood Flow Imaging with Ultrafast Doppler
    05:57

    Blood Flow Imaging with Ultrafast Doppler

    Published on: October 14, 2020

  • MDDS devices are defined by their function to transfer, store, convert, or display medical device data without altering connected device functions.
  • MDDSs are not intended for active patient monitoring and are exempt from premarket notification.

    • Conclusions:

    • The reclassification simplifies regulatory pathways for MDDSs.
    • This facilitates broader adoption and accessibility of medical device data management technologies.
    • Ensures continued oversight through general controls for class I devices.