As far as I know, bandage should be gone through 510K or regulated by FDA. It sounds like it is categorized as a medical device. But it is not for diagnose tool, treat disease or affect structure in human. Not all of products getting 510K are not medical device or they are still medical device?
No, not all products require a 510k, but all devices getting a 510k are a medical devices. If the device is something non-invasive, and simple such as that of a band aid, it would be classified as a class I device. Most class I, and few class II devices require 510k's. However, these devices are still subject to certain more general controls. To answer your other question, a device is typically defined as something created for a specific use, and because a band-aid is used to help a person when injured, it falls into the category of a medical device.
The FDA definition for a medical device captures a broad spectrum of products that one may not initially consider a medical device. An example of this would be a bedpan. Although a band-aid is not used to treat a disease, it is used to prevent infectious diseases.
For the full definition of a medical device, please take a look at the following link:
The FDA defines a medical device as: an instrument, apparatus, implement, machine, contrivance, implant, in vitro regent, or other similar or related article, including a component part or accessory which is recognized in the official National Formulary or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body for man or other animal, and which does not achieve its primary intended purposes through chemical action within and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
From Dr. Simon’s first week lecture, the FDA defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, invitro reagent or other related article or component part which is recognized in the National Formulatory or USP, is intended to diagnose the disease; cure prevent or treat the disease in humans or animals; intended to affect the structure or function in a animal or human without chemical action; is not dependent on being metabolized to work.
About 47 percent of authorized devices in the market are class 1 devices. These devices should comply with general Controls (the basic provisions (authorities) of the May 28, 1976 Medical Device Amendments). The general controls include the provisions of the act pertaining to adulteration, misbranding, device registration and listing, premarket notification, banned devices, Notification and repair, replacement, and refund, Records and reports, Restricted devices, and Good manufacturing practices.
Opposite to what jb678 said, most of class 1 devices are exempt from 510(k).
General band-aids are classified class 1 as they present no unreasonable or potential risk to health, and are not intended to be used to support or sustain life. That being said, a special type of band-aids with additional claims might be categorized as class 2 or even 3 and might require a 510(K) or PMA, based on the risk and prior existence of similar technology devices.
Everything classified as a medical device would require a 510(k), unless they are exempt. Bandages are considered as class I medical devices used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure to secure objects to skin as stated by the FDA, however they are 510(k) exempt. Regulation number 880.5240 list Medical Adhesive Tape And Adhesive Bandage as class I devices that are exempt from 510(k) or premarket notification procedures, since they are only limited for use as a skin protectant. This does not mean that there are no requirements in order to market this product; these products can be audited anytime by the FDA to ensure that it passed all the testing listed in the Design Verification/Design traceability matrix in order to ensure that it is safe and effective for its intended use.
I am agree with previous posts that all medical devices require to get a 510K but we should also consider FDA has a broad definition and steps to consider a device as a medical device for example for determination if a product is regulated by the FDA as a medical device we need to pass two steps: 1- Determine if your product meets the definition of a medical device per Section 201h [ of the Food, Drug & Cosmetic Act and step 2 determination if an appropriate product classification exists for your product. Medical device is not consider for devices are used for diagnose tool, treat disease or affect structure in human.
If the devices is non-invasive it can still be categorized as a class 1 medical device. All medical devices do need a 510k to be classified as a medical device. This is the same for medical devices that do or do not need to go through clinical trials. In this case a bandage is a class 1 device that does not need a 510k. This medical adhesive tape is being used for medical purposes and is exempt from 510 k approval.
If a device has been processed under a 510K then yes it would be considered a medical device. There are different classes of medical devices some be a simply as a medical band aid or medical tape are as advance as a pancreas insulin regulator. Even a band aid might be a class one and does not need a 510K it can still be filed under it and be considered a medical device.
