The document outlines the importance of calibration in the medical device industry, adhering to FDA guidelines to ensure device accuracy and precision. It emphasizes that regular maintenance, documentation of calibration procedures, and adherence to standards are crucial for patient safety and effective device use. Manufacturers must implement training for calibration personnel and maintain thorough records to comply with federal regulations.

1. CALIBRATION PROTOCOL
USFDA GUIDELINES
Manimegalai.G
561772035
B.Pharm IV year
Advanced Instrumentation Technique
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2. CALIBRATION
• It is a comparison between the known measurement (standard) and the
measurement using the instrument.
REASON FOR CALIBRATION
• A new instrument
• After an instrument has been repaired or modified
• When a specified time period has elapsed
• When a specified usage (operating hours) has elapsed
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3. INTRODUCTION
• Calibration of a device is carried out to minimize the uncertainty in
measurements.
• It helps in reducing the errors and brings the measurement to an
acceptable level.
• With repeated use and over a period of time, all equipment tends to
degrade and that affects its accuracy and precision.
• In the medical device industry, a drift in the measurement is
unacceptable.
• Regular maintenance and service are needed for an instrument to work
accurately and at its optimum.
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4. • For medical device manufacturers, the health and safety of patients
remain their top priority.
• Therefore, the precision and accuracy of a device is of utmost
importance.
• To safeguard the interest of the users and to ensure that public health
and safety isn't compromised, the medical device industry is regulated
by strict standards, including FDA's 21 CFR Parts 11 and 820, Quality
System Regulation (QSR) and ISO 13485.
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5. USFDA GUIDELINES
• Title 21 of the FDA's Code of Federal Regulations defines the
calibration requirements for equipment.
• According to section 820.72, manufacturers have to inspect, measure,
and test equipment to ensure that it is suitable for its intended use and
that it is capable of providing valid results.
• It also states that manufacturers must have provisions to handle,
preserve, or store the equipment.
• These activities have to be recorded and documented.
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6. ANALYTICAL PROTOCOL
• Calibration must be performed on a regular basis to check its accuracy
and precision and, if any errors are found, corrective measures have to
be taken if any, must be evaluated and documented.
• The procedures for how to calibrate an instrument must be easily
accessible to the designated staff of the company.
• Procedures should include how to calibrate the instrument and should
include the acceptable range for accuracy and precision.
• The procedure that is used to inspect, measure, and test equipment
should be traceable to national or international standards.
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7. FDA guidelines for calibration of a medical device
require the following
• Equipment calibration must be carried out routinely, as per the
company's written directions.
• Calibration of every device that needs to be calibrated must be
documented.
• Acceptable limits for accuracy and precision must be specified.
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8. • Calibration personnel must be trained.
• Calibration standards must be traceable to the national standards, in-
house standards (if necessary), or other acceptable standards have to
be used.
• Provisions have to be made for evaluating adverse effects caused by
the defective equipment, and corrective measures must be taken.
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9. REQUIREMENTS FOR CALIBRATION
• Calibration
• Standards
• Documentation
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10. CALIBRATION:
• As per FDA's medical device calibration requirements, all medical
device companies need to have procedures in place that include
instructions and acceptable limits for accuracy and precision.
• If a medical device fails to meet these standards for precision and
accuracy, then the manufacturer must calibrate the medical device to
improve its quality until the standards are met and must document all
procedures involved.
• Calibration shall be completed within +/- 7 days from the due date for
critical equipment & non critical equipment shall be completed within
+/- 15 days.
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11. STANDARDS
• If the standards for calibrating a medical device are absent, FDA
states that relevant national, international, state, or local standards
need to be applied.
• If no standard exist, the manufacturer must form its own set of
requirements, and the medical device must be calibrated to meet those
requirements.
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12. DOCUMENTATION
• Part 21 CFR 820.72 states that manufacturers must document all the
points of calibration, including the following:
• The date the device was picked up for calibration.
• The name of the staff who performed the calibration.
• When the next calibration is due.
• All of these records need to be made accessible to the designated
personnel of the company.
• For an instrument calibration program to remain in compliance with
FDA, it is important to maintain a calibration schedule. Missed
calibration cycles can compromise the quality of the product, resulting
in non-compliance.
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