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Results for “Device Approval”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 721 records · Page 40Linked to original sources
PubMed1996

Home HIV tests: the need for regulation.

In-home testing for HIV/AIDS will be available nationwide in early 1997. Because laws regulating these over-the-counter test kits vary widely from state to state, national uniform regulations are needed to safeguard the rights of consumers and to protect health care providers from professional liability.

AIDS Serodiagnosis↗
PubMed1996

Medical device recall authority--FDA. Final rule.

The Food and Drug Administration (FDA) is establishing procedures for implementing the medical device recall authority provided in the Safe Medical Devices Act of 1990 (the SMDA). This statutory authority protects the public health by permitting FDA to remove dangerous devices from the market promptly. This authority complements other provisions of the device law, including tracking and notification.

Device Approval↗
PubMed1996

A US FDA medical device update, Part II.

This column in last month's edition discussed answers to some of the questions raised at a recent Food and Drug Administration (FDA) conference held in Paris. This article continues that discussion and includes questions and answers concerning harmonization and good manufacturing practice (GMP) requirements. As in the preceding column, the answers were provided by FDA speakers at the conference or subsequently confirmed in discussions with the author.

Device Approval↗
PubMed1997

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); clarification of the CHAMPUS exclusion of unproven drugs, devices and medical treatments and procedures--DoD. Final rule.

This final rule clarifies the CHAMPUS exclusion of unproven drugs, devices and medical treatments and procedures and describes the process that the Office of CHAMPUS follows in determining when such drugs, devices, treatments and procedures have moved from the status of unproven to the position of proven medical effectiveness. This clarification is necessary to ensure the CHAMPUS beneficiary and provider population understand the process the Office of CHAMPUS (OCHAMPUS) follows prior to endorsement by CHAMPUS of a new emerging medical technology, drug, or device for which the safety and efficacy have been proven.

Device Approval↗