Devices & Diagnostics Letter

A new draft guidance aims to expedite the device approval process by clarifying the reasons the FDA can reject a PMA during the acceptance and filing process.

A key Republican lawmaker is calling for more thorough government probes into the FDA’s monitoring of nine of its scientists as new information shows the agency may have broken more laws than congressional investigators previously believed.

Ningbo Huahui Medical Instruments was handed an FDA warning letter after telling investigators it lost its design documents last year for a digital thermometer.

The FDA last week got a preview of the comments it can expect in response to its unique device identifier (UDI) draft rule ranging from whether a change in UDI would require a new supplemental PMA or 510(k) to questions about date formatting required by the rule.

The fiscal 2013 medical device user fee rates laid out in a Tuesday Federal Register notice match amounts set during MDUFA negotiations between the agency and industry representatives.

European devicemakers will be required to use a new labeling standard that reduces the need for multiple languages on a single label and reduces potential confusion and delays for selecting the appropriate language when using a device.

Device approvals may take longer in the U.S. than in the EU — but the fact that U.S. insurers are quicker to pay for new technologies means patients benefit from new devices at roughly the same speed in both places, a new study suggests.

Medical devicemakers must begin registering foreign-manufactured goods that pass through the U.S. but are not sold here under a new FDA rule.

The European Parliament and Council are wrapping up their review of a proposed regulation that would ban several types of mercury-containing medical devices because of their potential toxicities.

Healthcare regulatory affairs professionals in North America saw their salaries and bonus levels rise by an average of three percent in 2011, making modest but notable compensatory gains during a year punctuated by severe cutbacks and grinding economic malaise, a new report finds.