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PubMedDate not supplied

Medical device directive: preparing for the amendments.

Article 21 of the In Vitro Diagnostic (IVD) Directive (98/79/EC) contains several important amendments to the Medical Device (MD) Directive (93/42/EEC). This is generally well known. However, the amendments are not always being kept in mind when discussing the requirements of the MD Directive. This article reviews the more important amendments and suggests that it is time to begin planning for them. The new definition of IVD products is also provided.

Device Approval↗
PubMed2000

New routes to the United States: special and abbreviated 510(k)s.

Special and Abbreviated 510(k)s are two new approaches to obtaining clearance for medical devices to be marketed in the United States (US) that are designed to streamline the traditional 510(k) review process. This article answers commonly asked questions relating to the requirements for these types of 510(k)s, preparation of applications, and how the US Food and Drug Administration handles these submissions.

Device Approval↗
PubMed2000

Notified body recommendations.

This article discusses the Notified Body recommendations issued by the European Forum of Notified Bodies Medical Devices and its subcommittee, the Notified Bodies Recommendations Group. Most of these recommendations represent more detailed guidance documents than the consensus statements issued by this group, which were discussed in a previous article. Some of the recommendations form the basis of the European-level MEDDEV guidance documents.

Device Approval↗
PubMed2000

Medical devices; gastroenterology-urology devices; nonimplanted, peripheral electrical continence device. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Device Approval↗
PubMed2000

Cardiovascular, orthopedic, and physical medicine diagnostic devices; reclassification of cardiopulmonary bypass accessory equipment, goniometer device, and electrode cable devices. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is reclassifying from class I into class II the cardiopulmonary bypass accessory equipment device that involves an electrical connection to the patient, the goniometer device, and the electrode cable. FDA is also exempting these devices from the premarket notification requirements. FDA is reclassifying these devices on its own initiative based on new information. FDA is taking this action to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices.

Cardiopulmonary Bypass↗
PubMed2000

Medical devices; exemptions from premarket notification; class II devices; vascular tunnelers. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is publishing an order granting in part a petition requesting exemption from the premarket notification requirements for vascular tunnelers with certain limitations. This rule will exempt from premarket notification stainless steel vascular tunnelers of single unit construction. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Device Approval↗
PubMed2000

Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Device Approval↗
PubMed2000

Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices.

Device Approval↗
PubMed1999

Medical devices; gastroenterology and urology devices; classification of the electrogastrography system. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is classifying the electrogastrography system (EGG) into class II (special controls). The special controls that will apply to the EGG system are restriction to prescription use, certain labeling requirements, design requirements, and data collection requirements. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying the EGG system into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Device Approval↗
PubMed2000

An overview of laser wavelengths used in dentistry.

The scientific basis and tissue effects of dental lasers have been discussed. It is most important for the dental practitioner to become familiar with those principles, then choose the proper lasers for the intended clinical application. Although there is some overlap of the type of tissue interaction, each wavelength has specific qualities that accomplish a specific treatment objective. Other articles in this issue provide an in-depth study of the uses of lasers in dentistry.

Argon↗