Related Experiment Video
Updated: Oct 3, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Medical Device; exemption from premarket notification; class II devices; pharmacy compounding systems. Final rule
Abstract:
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for pharmacy compounding systems classified within the intravascular administration set, with certain limitations. This rule will exempt from pre market notification pharmacy compounding systems classified within the intravascular administration set and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).
More Related Videos
08:26Dissolving Microneedle Array Patches Manufactured By Solvent Casting Technique and Essential Characterization of Microneedle-Based Biomedical Devices
Published on: January 30, 2026
03:49Enhanced Cochlear Coverage and Hearing Preservation in High-Frequency Hearing Loss via Electric Acoustic Stimulation with Longer Electrode
Published on: October 11, 2024
Related Concept Videos
Clinically Relevant Drug Product Specifications: Methods of Establishment
FDA Approved Drugs: Changes to Approved Drugs
Drug Products: Biologics, Biosimilars and Interchangeables
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
Drug Regulation
Modified-Release Drug Delivery Systems: Classification