Medical devices premarket approval

Kahan, J. S. (1991). Clinical utility and medical device premarket approval. Medical Device and Diagnostic Industry 13 62-64. 

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. 

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... 

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. 

Under the Medical Device Amendments of 1976, the FDA is responsible for premarket evaluation of all laboratory testing devices (in vitro diagnostics) intended to be commercially marketed in the United States. There are two major pathways for introducing a medical device into the marketplace the premarket notification [510(k) clearance] and the premarket approval (PMA). The purpose of the 510(k) is to establish that a device is substantially equivalent (SE) to a legally marketed (predicate) device. The purpose of the PMA evaluation process is to establish the intrinsic safety and effectiveness of a new device. Unless specifically exempt, a sponsor must have an approved PMA or cleared premarket notification [510(k)] by the FDA before a device may be legally marketed for IVD use (Fig. 1). 

The Medical Device Amendments pass to ensure safety and effectiveness of medical devices including diagnostic products, requiring some quality control, premarket approval, and performance standards on some products. 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

An application for Premarket Approval of a Medical Device, described in section 515 of the act. 

The FDA is responsible for the review and market approval of new drugs, biologies, and medical devices in the United States under the authority of the Federal Food Drug and Cosmetic Act (the Act) and Section 351 of the Public Health Service Act (the PHS Act). The FDA defines premarket review as the examination of data and information in an application as described in Sections 505, 510(k), 513(f), 515, or 520(g) or 520(1) of the Act or Section 351 of the PHS Act. This refers to the premarket review of data and information contained in any Investigational New Drug application (IND), Investigational Device... 

Abbreviated new drug applications are submitted to gain approval of generic versions of already approved drug products. Premarket notification [510(k)] applications are the mechanisms for marketing medical devices that are substantially equivalent to already marketed device products. Both of these applications are based on approved similar product information. 

Two types of regulatory approvals exist for medical devices in the United States, 510(k) notification and premarket approval (PMA). The types of tests required for approval depend on the classification of the medical device. 510(k) notification involves marketing a device that is substantially equivalent to a device on the market prior to 1976. All devices introduced after 1976 that are not substantially equivalent to devices on the market before 1976 are automatically classified as Class 3 devices and require PMA (16). For a device fo be considered subsfantially equivalenf to a device on the market before 1976, it must have the same intended use, no new technological characteristics, and have the same performance as one or more devices on the market prior to 1976. In addition, all medical devices must be sterilized either by end-sterilization or by some other acceptable means that can be validated, which means that any test done in cell culture or in an animal model must be conducted on a device that has been validated to be sterile. Sterility validation is conducted on all medical devices as described in the literature (17). 

Medical Device Amendments required manufacturers with the FDA and follow quality control procedures with some products needing premarket approval and others needing to meet performance standards before marketing. 

Includes information for medical devices general, labeling, reporting, in vitro diagnostic products, investigational device exemptions, premarket approval, postmarket surveillance, and classification procedures. 

Medical devices may be marketed for sale in the United States after receiving either a premarket notification 510(k) or premarket approval (PMA) from the FDA. 

Class III—Premarket Approval Devices that support or sustain life or present a significant risk of illness or injury fall under the Class-Ill category. Implants, such as pacemakers and silicone gel breast implants, are Class-Ill products, as are internal tissue adhesives, thermal ablation devices, synthetic ligaments and tendons, vacumn pumps, and prosthetic hips. Class-Ill accounts for about 10% of aU medical devices. 

Reuse of single use products. Especially valuable are the searchable CDRH databases. These include Manufacturer and User Device Experience (MAUDE) PMA, Premarket Notifications [510(k) s], and Device Listings, a list of medical devices in commercial distribution by both domestic and foreign manufacturers. The OCP site includes examples of newly approved combination products guidance documents related to combination products jurisdictional updates (among CDRH, ODER, and CBER) and instructions for submitting an RED. 

There is the long-standing belief that the approval process for medical devices is much faster than the IND/NDA drug method. This is certainly true for Class I, Class II, and some preenactment Class III devices—products that can be cleared through Premarket Notification or 510 (k) submissions. Such products are often approved for commercialization in 90 days or less. However, the difference in time is less apparent for manufacturers of new Class III products, where preclinical studies, clinical trials, and the premarket approval process is required. Statistics with respect to time of inception through time to market for new Class III devices are not readily available, but in the author s opinion it would be similar to that required for a new drug. 

The Medical Device User Fee and Modernization Act (MDUFMA) amended the Federal Food, Drug and Cosmetic Act to provide the FDA with important new responsibilities, resources, and challenges [7]. The MDUFMA has three significant provisions (1) Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), Biological License Applications (BLAs), certain supplements, and 510(k)s are now subject to fees. (2) Establishment inspections may be conducted by... 

Clinical data are required in all premarket approval applications. The PMA applicant must provide a cogent demonstration of the safety and effectiveness for all diagnostic and/or therapeutic medical claims for the device based on laboratory, animal, and clinical data. 

Under section 515 of the act, all devices placed into Class III are subject to premarket approval requirements. Premarket approval is the process of scientific and regulatory review to ensure the safety and effectiveness of Class III devices. An approved PMA is, in effect, a private license (some would say a regulatory patent) granted to the applicant for marketing a particular medical device. A Class III device that fails to meet PMA requirements is considered to be adulterated under section 501 (f) of the act and cannot be marketed. Premarket approval requirements apply differently to preamendment devices, postamendment devices, and transitional Class III devices. 

Congress amended the Federal Food, Drug, and Cosmetic Act (21 U.S. C. 301 et seq.) in 1976 to require premarketing approval of medical devices (Public Law 99-295). 

CDRH approves medical devices through the premarket notification and premarket approval processes. Most marketed devices are approved by the FDA via submission of a Premarket Notification or 510(k). A 510(k) notification is required for Class I devices that are not exempt from notification, all Class II devices, and certain Class III devices. A 510(k) is a premarketing submission demonstrating that the device to be marketed is substantially equivalent to, or as safe and effective as, a legally marketed device that is not subject to premarket approval. The legally marketed, comparator device is termed the predicate device. 

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