Class 1-3 medical devices

Medical devices that are very simple by design and have a very low potential to cause harm are classified as what Class Medical Device ... 

Colorants. According to U.S. regulations, colorants are divided into two classes certified and exempt (see Colorants for foods, drugs, COSMETICS, AND MEDICAL DEVICES). Batch samples of certified colors must be sent to the FDA for analysis and confirmation that the colorants comply with estabhshed specifications. Color manufacturers pay a small fee for each batch of color that is analy2ed. The number of certified colors available to food technologists has declined. Several of the historical colorants were found to have carcinogenic effects. Table 1 shows the certified colors that are permissible for food use in the United States as of 1993. 

The pharmacist or physician can report any problems experienced with dmg products and medical devices. In cases where the PDA and/or manufacturer finds that a marketed product constitutes an actual or potential threat to the safety and welfare of the pubhc, that product must be withdrawn from the marketplace, ie, recalled. Several classes of recalls exist, depending on the relative danger that the product exhibits. C/ass I dmgs pose a serious health threat and may require withdrawal at the consumer level C/ass II dmgs pose a possible or potential health problem that usually means withdrawal at the pharmacy or wholesaler levels and C/ass III dmgs may present a remote hazard to health and safety. 

All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I ... 

All devices intended specifically to be used for disinfecting medical devices are in Class lla, unless they are specifically to be used for disinfecting invasive devices in which case they are in Class Mb. 

As a general rule, clinical data are required as evidence to support conformity with the requirements of the Active Implantable Medical Devices (AIMD) and the Medical Device (MD) directives with regards to safety and effectiveness under the normal conditions of use, evaluation of undesirable side effects, and the acceptability of the benefit/risk ratio. Risk analysis should be used to establish key objectives that need to be addressed by clinical data, or alternatively to justify why clinical data are not required (mainly for Class I devices). The risk analysis process should help the manufacturer to identify known (or reasonably foreseeable) hazards associated with the use of the device, and decide how best to investigate and estimate the risks associated with each hazard. The clinical data should then be used to establish the safety and effectiveness of the device under the intended use conditions, and to demonstrate that any of the residual risks are acceptable, when weighed against the benefits derived from use of the device. 

The FDA of the U.S. Department of Health and Human Services (DHHS) administers the regulatory controls for the Food, Drug, and Cosmetic Act of 1906 and the 1976 and 1990 amendments, which provide approval for commercial distribution of safe and effective medical devices. The 1976 amendments directed the FDA to regulate medical devices under control levels that are necessary to ensure safety and effectiveness. In order to achieve this task, the Medical Device Law under the amendments required the FDA to issue regulations placing all medical devices on the market at that time into one of three regulatory classes ... 

Medical devices are regulated on the basis of a three-level risk classification. The highest risk products are the class 3 products that require premarket applications, almost always with clinical data that demonstrate that the product is safe and effective for the intended use. By default, a novel product is a class 3 product unless there is an approval application for initial approval as a class 2 device (the de novo process). Clinical trials for class 3 products before they are approved usually require an IDE, which is similar to the IND required for investigational drugs. 

Class 1 medical devices, which include some simple IVDs, are usually exempt from the premarket section 510(k) application process, and their manufacturers are only required to register and list, follow good manufacturing practices, and report device failures. As experience develops with a given medical device it can be reclassified downward from class 3 to class 2 and eventually to class 1. 

Medical grade plastics are discussed with reference to biocompatibility and the tests that the end-product manufacturer should perform in order to ensure the safety of the material. Regulatory requirements are described, and tabulated data is presented on mostly European suppliers of medical grade plastics. The data shows that most companies rely onUSP Class VI certificates to demonstrate the suitability of their materials for the medical industry. However, it is argued that most manufacturers of medical devices would benefit more from tests carried out according to ISO 10993. 6 refs. 

Chapter 5 of the document reviews the UFs used by UK Government departments, agencies, and their advisory committees in human health risk assessment. Default values for UFs are provided in Table 3 in the UK document with the factors separated into four classes (1) animal-to-human factor, (2) human variability factor, (3) quality or quantity of data factor, and (4) severity of effect factor. The following chemical sectors are addressed food additives and contaminants, pesticides and biocides, air pollutants, drinking water contaminants, soil contaminants, consumer products and cosmetics, veterinary products, human medicines, medical devices, and industrial chemicals. 

A manufacturer must apply an appropriate conformity assessment procedure to their device in order to ensure that it complies with the essential requirements, after which they must certify this fact by completing a declaration of conformity. There is usually a choice of conformity assessment procedures open to a manufacturer, depending on a risk-based classification of the class into which the device falls. The two main approaches to conformity assessment are based either on an approved total quality management system audited to ISO 9000 series standard, as customised for medical devices with EN 46 000 series standard, or individual product assessment. 

Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and which is liable to act upon the body with action ancillary to that of the device (e.g. a heparin-coated catheter), the product is classed as a medical device. However, the medicinal product is to be assessed in accordance with the requirements of Directive 75/318/EEC (replaced by 2001/83/EC and updated by 2003/63/EC). A notified body undertaking conformity assessment on a medical device which incorporates a medicinal substance having ancillary action has a responsibility to consult a national medicines agency about the medicinal substance, to verify its safety, quality and usefulness by analogy with the appropriate methods specified in Directive 75/318/EEC. 

Depending on the class of the device, a manufacturer may be able to choose between a number of alternative conformity assessment procedures in the assessment of whether a medical device conforms to the essential requirements. Although the rules should be considered in detail in each case, the basic options might be summarised as follows ... 

A non-EEA manufacturer may place a Class I or custom-made medical device or a system or procedure pack on the EU market under their... 

Marketing application for some class III medical devices. 

Just about any medical apparatus or diagnostic device may have applications for medical-grade adhesives. Traditionally, there are three classes of medical devices that have been assembled with adhesives ... 

Adhesives used in medical devices are tested for their effect on cells (cytotoxicity), blood constituents (hemolysis), and adjacent tissues, and for overall systemic effect. Several classes of biocompatibility testing exist. Adhesive suppliers, however, generally test to the following guidelines that have been established for toxicological properties and biocompatibility ... 

---