A medical device should not be placed for sale in the market unless it passes industry standards. This is generally because they are used to respond to medical necessities of end users. Equipment irregularities may not just be a reason for hazards on the life of the patient. Even medical professionals are not exempted from unhygienic medical machineries. This is why federal guidelines need to be met.
Federal guidelines are standards set for any item in the market. The Food and Drug Administration or FDA oversees the manufacture of medical devices. Find out how FDA categorizes the industrial items and see the standards behind these industrial products’ assembly.
Three classifications for medical devices
The FDA utilizes Class I, Class II and Class III to simply classify medical devices. Class I devices are those with general controls. Class II are those that mix special and general controls in the facets of the medical gadget. Class III are those that need FDA premarket approval.
Class I medical devices include basic gadgets such as bandages, bedpans and gloves. These devices need safety, sanitation and other medical procedures no matter how less the risk they render to the end user. Class II, on the other hand are devices that pose greater risks. Included on the list are x-ray machines, suture materials and surgical needles. Class III are considered the most hazardous of all medical tools and concrete samples include bone implants and pacemakers.
Guidelines for assembly of medical devices
The federal standards are created in assuring that the medical device is sanitized and more efficient. Both consumers and health practitioners will see the relevance in these guidelines. The necessary steps include registration, listing, premarket notification, premarket approval, investigational device exemption, quality system regulation and labeling requirements.
Registration is that stage of the process where the business should register the medical tool. Renewal is made every year. Listing is that step where the business owner – whether an exporter, manufacturer or remanufacturer – must enlist all the facilities with the FDA. Premarket notification is significant before the end products are marketed while premarket approval is required for any Class III medical device.
Investigational device exemption is different from all the rest of the processes since it is needed only for a certain purpose. This is required when clinical testing is the topmost purpose of the product. On the other hand, both quality system regulation and labeling requirements should be met by the manufacturer. Quality system regulation is that process where facilities for packaging, manufacturing, labeling and storing are inspected. Labeling requirements oversee not just the product label but the details explained on the literature of the medical device.