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The FDA should go ahead with its plan to apply the same regulatory standards to direct-to-consumer (DTC) broadcast ads for restricted medical devices that apply to the same type of ads for prescription drugs, according to the FTC.
A Flordia laser firm received an FDA warning letter last month that could have possibly been avoided if the company had addressed numerous quality system (QS) violations the agency observed during three inspections since 2002.
The FDA has cited a California hospital’s institutional review board (IRB) for inadequately reviewing clinical device trials and failing to provide accurate documentation about its membership and oversight process.
The FDA has ordered a Colorado light therapy firm to immediately remove a series of misleading ads and promotional materials that market its products for unapproved indications and use a false FDA letter to confirm its therapeutic claims.
FDA approval for St. Jude Medical’s newest implantable cardiac defibrillators (ICDs) has been delayed by at least two months, prompting the company to lower its second-quarter earnings outlook.
Medtronic’s diabetes division MiniMed launched a nationwide recall May 18 of all Quick-Set Plus infusion sets after receiving reports that design problems can interrupt insulin flow to diabetics using the devices.
The FDA has released a new guidance updating industry on the effect various review actions have on Medical Device User Fee Modernization Act (MDUFMA) time goals during the premarket 510(k) submission process.
HHS has launched an internal task force to promote the development of innovative medical technologies into applicable patient treatments utilizing drugs, biologics and medical devices.
Guidant and St. Jude Medical released new trial data last week that could help up the ante in devicemakers’ efforts to expand coverage for defibrillators.
The Generic Pharmaceutical Association (GPhA) wants the FDA to add regulatory language that would expressly require a brand firm to correct or delete patent information in the agency's Orange Book when a court order requires patent changes.