Medical Device Classification

by Kelly Shelton Biotech Research Group is one of the leading data-

The Food and Drug Administration (FDA) has classified around 1,700 different generic types of medical devices and grouped them into 16 panels. The purpose of the Medical devices classification is to take appropriate regulatory control for the device. On the bases of safety, effectiveness, and control every generic type of devices has three regulatory classes include Class1, Class II, and Class III. These three classes and all the requirements that applied to them are:

Class I: General Controls

All the devices are classified in Class 1 devices that need the least regulatory control. It is the subject of the “General Controls" and all the included provisions are related to misbranding and adulteration, banned devices, replacement, repair, premarket notification, device listing and registration. Class 1 devices are mostly exempt from the premarket notification and good manufacturing practices regulation because they don’t cause any unreasonable risk of injury or illness and also don’t support life. Examples of Class I devices include gloves for examination, hand-held surgical instruments, and bandages.

Class II: General controls with special controls

Class II devices require general controls along with special controls as general controls cannot assure the effectiveness and security alone. This is the reason all the devices that are classified under the Class II are subject to special control also. All special control includes special labelling, postmarked surveillance, and mandatory performance standards. All the devices in Class II need more assurance as compare to the Class I but still, they are designed to use without causing injury or harm to the users. Examples of Class II devices include wheelchairs, acupuncture needles, air purifiers, and surgical drapes.

Class III: General Controls, Special Controls, and Premarket Approval

Class III devices include all the devices that are important to support human and also significant to prevent the impairment of human health. To assure safety and effectiveness of class III devices there is the need of general control, special control, and premarket approval. Examples of Class III devices that currently require a premarket notification include a pacemaker, HIV diagnostic tests, pulse generators and automated external defibrillators.

Scientific Research:

The Scientific research is the study done to perform the work with systematic planning. When there is the research done to contribute toward the science in a planned manner then it is called scientific research. There is the systematic collection, interpretation as well as evaluation of the data before performing any experiments on it. The initiation of the scientific research requires the determination of the subject, planning, and specification of the methodology to reach something productive. There are different reasons associated with the scientific research that includes understanding about the reasons, effects, development of the diseases and then search for the protection and therapies of the diseases. The questions and method of response for different scientific research may vary but the structure for the scientific research mostly same all the time. The classification of the Scientific Research can be done in many ways. This is based on the data collection and the techniques that may use for the subject. There is the classification of the Scientific Research and that is:

1. Data Collection Based:

• Observational

• Experimental

2. Causality Relationships Based:

• Descriptive

• Analytical

3. Time-Based:

• Prospective

• Retrospective

• Cross-sectional

4. Medium Based:

• Laboratory

• Clinical

• Social Descriptive Research

Overall, scientific research or studies help Company to come up with the answers related to the objective, rational, and about the different methods. The scientific research needs to extensive reviews of the literature to get the exact results. Our organization is providing companies with scientific research. We offer literature reviews for the investigations of the new drugs to help you to initiate your work. Our highly experienced consultants will help you to create the best strategic plans for scientific research. The best product development that can get the approval from FDA there is the need of the scientific research. The extensive scientific reviews can help you in approval and disapproval of anything that you want. Our researchers perform their study in best way and try to observe the world around them to make a clear path for scientific experiments to reach an objective.