Premarket approval devices

The FDA will consider awarding grants only to support clinical studies for determining whether the products are safe and effective for either premarket approval (devices) or in support of an IND for drugs or biologies. Investigations... 

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. 

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. 

Class III Premarket Approval. Similar to a new dmg approval, a premarket approval grants the appHcant a Hcense to market a specific weU-characterized device. These devices are subject to the requirements of Section 515 of the Eood, Dmg, and Cosmetic Act. A post-amendment device is a device put ia commercial distribution after May 28, 1976. If it is not substantially equivalent to a preamendment device it is automatically ia Class 111, and a premarket approval appHcation (PMA) is required. The appHcation must iaclude reports of preclinical and clinical studies done ia support of claims of safety and efficacy as well as any labeling claims made for the device. Once the PMA is submitted, the PDA determines whether the appHcation iacludes the required information. If the PMA is suitable for scientific review, the PDA has 180 days from the filing date to approve or deny the appHcation. Polybutester, polydioxanone, polyglyconate, and ePTPE sutures are all regulated as Class 111 devices. 

Regulation. Dental implants are regulated by the Food and Dmg Administration. AH dental implants faH iato the FDA class III which covers devices that are life sustaioiag, life supportiag, or are implanted iato the body and have the potential to cause unreasonable risk, illness, or iajury. Devices ia class III are requited to have appHcatioas for premarket approval (315). There are 15 to 20 companies that have FDA marketing clearance for specific dental implants, based on substantial equivalency to implants marketed prior to 1976, and approximately one third of these companies are foreign. Marketing clearance is not the same as premarket approval. 

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. 

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... 

When an IVD is developed as a kit or system to be used with specific equipment and is sold to multiple laboratories, it is considered a device in interstate commerce and is subject to premarket review. When the IVD is a novel test, premarket approval (PMA) will be based on the analytical and clinical validation that will determine whether the test is safe and effective for clinical use. When there is evidence that the IVD is substantially equivalent to a legally marketed device, FDA clears such tests under section 510(k) of the Device Amendments to the Food, Drug and Cosmetic Act. The necessary level of evidence and requirements are described in more detail below. 

F. Premarket Notification, Investigational Device exemptions including Humanitarian Exemptions, Premarket Approval, Product Development Protocols, Classification, Device Tracking, Petitions for Reclassification, postmarket surveillance under Sections 510(k), 513, 515, 519, 520(g) and (m), and 522, and the advisory committees necessary to support these activities. 

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). 

Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE), or Premarket Approval (PMA) numbers for device trials... 

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. 

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

Exemption (IDE), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologies License Application (BLA), device premarket notification [510(k)], or device Premarket Approval Application (PM A). 

Devices subject to premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (the Act) are also subject to periodic reports imposed by the PMA approval order [21 CFR 814.82(a), 21 CFR 814.84(b)], We typically specify that you submit a report one year from the date of approval of the original PMA and annually thereafter. Therefore, the periodic report is usually referred to as an annual report. Although this guidance addresses annual reports, there may be circumstances where FDA specifies more frequent periodic reports. We believe this guidance will also be relevant to the more frequent reports. 

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. 

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 1976 to require premarket notification for all medical devices, and premarket 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 and further refined by the Medical Device Amendments of 1992 and the Food and Drug Administration Modernization Act of 1997. ... 

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

The premarket testing of devices via clinical trials is distinctly different from drug trials. Drug trials generally involve large munbers of participants, as safety and efficacy must be demonstrated prior to approval. Device trials are more... 

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. 

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. 

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