Medical devices, approving

The State Institute for Drug Control is responsible for supervision in the pharmaceutical sector, medical device approval, the registration process, clinical trial approval, withdrawcil of drugs cmd medical devices, control of advertising and inspection of GMP, GLP and GCP. 

I. NEW MEDICAL DEVICE APPROVAL PROCESS IN THE UNITED STATES... 

The U.S. Food and Drug Administration (FDA) is the main regulatray body for medical device approval in the United States. It is the job of the FDA to determine that a new medical device is both safe and effective. Each medical device must meet criteria of both safety (it can do no harm) and effectiveness (it must do what it purports to do). 

Davis, S., Gilbertson, E., GoodaU, S., 2011. EU medical device approval safety assessment a comparative analysis of medical device recalls, 2005-2009. Available at https //www. bcgperspectives.com/content/articles/medical devices technology public sector eu medical device approval safety assessment/ (accessed 05.01.16). 

Various medical devices based on Terathane have been approved by the U.S. FDA, including those used within the body. Formulators are cautioned, however, that FDA approval is not given genericaHy for these devices it must be appHed for separately by each manufacturer for each device. Additional data on safety of PTMEG may be found in the material safety and data sheets provided by the manufacturers. 

Two statutory provisions of Tide 21 govern the introduction of new medical devices into the marketplace. Section 515 estabHshes a premarket approval appHcation (PMA) containing data and information demonstrating the safety and effectiveness of a device. Section 510(k) estabHshes a premarket notification process. Under this process, a manufacturer is required to file with the EDA, 90 days before a new device is to be marketed, a premarket notification demonstrating that the device in question is substantially equivalent to a device that was on the market before enactment of the 1976 Amendment and therefore marketable without formal EDA approval. 

Color Additives. The FDA has created a unique classification and strict limitations on color additives (see also CoLORANTS FOR FOOD, DRUGS, COSMETICS, AND MEDICAL DEVICES). Certified color additives are synthetic organic dyes that ate described in an approved color additive petition. Each manufactured lot of a certified dye must be analyzed and certified by the EDA prior to usage. Color lakes are pigments (qv) that consist of an insoluble metallic salt of a certified color additive deposited on an inert substrate. Lakes are subject to the color additive regulations of the EDA and must be certified by EDA prior to use. Noncertifted color additives requite an approved color additive petition, but individual batches need not be EDA certified prior to use. 

The conduct of studies of medical devices in the US that have not been cleared/ approved by the FDA is regulated via Investigational Device Exemption (IDE) regulations set out in 21 CFR Part 812. Considering the type of device and the level of associated risk involved, investigations maybe conducted as IDE-exempted studies. Abbreviated requirement studies, or studies subject to full IDE requirements. 

In 1992, the FDA issued a moratorium on silicone-gel-filled implants, and restricted their use to reconstmction and clinical smdies. In 2000, they approved saline-filled implants. In 2003, the General and Plastic Surgery Devices (GPSD) Advisory Panel recommended reapproval of gel-filled implants, but the FDA decided to wait for more clinical evidence of safety. In late 2005, the Panel recommended conditional approval of Mentor s and Inamed s gel implants. In October 2006, Health Canada approved the use of sUicone-gel-filled implants, with a warning that no medical device is 100% safe. ... 

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 ... 

The Safe Medical Devices Act of 1990, a major revision to the 1976 amendments, among other revised requirements provided two major mechanisms for bringing an IVD medical device to market premarket notification and premarket approval. The act is administered by the FDA s Center for Devices and Radiological Health, of which the Division of Clinical Laboratory Devices (DCLD) is a part. The premarket notification process is used for devices that can be classified... 

A small number of biotechnology products are classified as medical devices and, hence, are regulated by the Center for Devices and Radiological Health (CDRH). The first approved biotech product to come under the auspices of the CDRH was OP-1 implant. Marketed by Stryker Biotech, OP-1 implant is a sterile powder composed of recombinant human oestrogenic protein-1 (OP-1) along with bovine collagen. It is used to treat fractured bones that fail to heal. The product is mixed with sterile saline immediately before application, and entails surgical insertion of the paste into the fracture. 

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. 

An overview is presented of the CE marking requirements for manufacturers of medical devices, the role of EU Notified Bodies and third party approval and the provision of relevant data to the manufacturers of medical devices. 

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