Federal Register :: General and Plastic Surgery Devices
To change the classification of the device, the new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its
Related Topics:
Regulations Management Spectrometers
USP General Chapter <1058>
In many regulated industries laboratories must demonstrate and document the suitability of analytical instruments and software for their intended use. This focus on compliance extends to how the
Procedure for gamma-ray spectrometry measurements for activity
The ORTEC DSPEC 502/502A Digital Signal Processing Gamma Spectrometers digital electronics are connected to the X-detector. The electronics are adjusted to optimize the detector performance.
Raman instruments calibration and verification protocols
Requirements for x-axis calibration and verification protocol (normative) Annex A
Federal Register, Volume 91 Issue 57 (Wednesday, March 25, 2026)
[Federal Register Volume 91, Number 57 (Wednesday, March 25, 2026)] [Rules and Regulations] [Pages 14445-14458] From the Federal Register Online via the Government
21 CFR § 862.2860
A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation
Quality Management System Regulation – Frequently Asked
The FDA has made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products.
Do We Qualify or Validate a Spectrometer?
Spectrometers have to be fit for their intended use; however, regulators separate analytical instrument qualification from computerized system validation. We critically review the qualification
General and Plastic Surgery Devices; Reclassification of Optical
General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided
OMCL Guidelines for Mass Spectrometer Qualification
It outlines parameters to test at different qualification levels, including minimum requirements and acceptance limits. Examples are given for mass accuracy, linearity, precision, identification, and
eCFR :: 21 CFR 866.3361 -
(1) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, standalone software applications and hardware-based devices that