Top Device Stories

CDRH’s lack of consistency in device trial requirements is driving small devicemakers out of business, stakeholders told CDRH officials at a recent meeting on strengthening the 510(k) review process.Read More

Contract manufacturer Hammill Manufacturing did not fully investigate complaints involving possible device failures, according to an FDA Form 483.Read More

The FDA is revamping its IT infrastructure to get ready for a final rule requiring device manufacturers to submit all medical device reports (MDRs) electronically. Read More

An increasingly difficult regulatory climate in the U.S. may be forcing U.S. devicemakers to launch their products first in the EU.Read More

Many devicemakers are not ready for the EU’s revised Medical Device Directives (MDD), and the accompanying national legislation, to go into effect this month. Read More

OMT, a maker of sterile neurosurgical products, has received a Form 483 for GMP violations, including failure to conduct internal audits.Read More

Devicemakers would pay $2 billion a year in fees to help fund healthcare reform legislation under a new proposal from President Barack Obama. Read More

Devicemakers seeking approval for a product in Hong Kong should justify placing it into a particular risk class, the country’s Medical Device Control Office (MDCO) says.Read More

The device industry will lose support in the Senate when Sen. Evan Bayh (D-Ind.) retires at the end of the year, according to devicemakers from his home state. Read More

Investigators will need to be more diligent in reporting their financial interests now that the FDA is stepping up its efforts to verify financial disclosures during site inspections.Read More

The U.S. Court of Appeals for the Ninth Circuit has affirmed a district court summary judgment that DePuy Spine did not promote its Charite artificial disc for off-label use. Read More

OST Medical, which manufactures Sentinel enteral feeding pumps, must bring in an independent expert to audit its quality systems (QS), according to a warning letter that cites the company for ongoing systemic violations in its QS and good manufacturing practice deviations.Read More

Federal budget pressures, coupled with a need to increase the FDA’s international presence, may give Congress the impetus to pass a new device user fee to cover the costs of reinspections.Read More

Industry is calling on the European Commission (EC) to increase global harmonization of device regulations, making the process mandatory rather than voluntary.Read More

Stakeholders want the FDA to clarify “unofficial policies” that are hampering the agency’s 510(k) review process, they told the agency at a meeting on strengthening the process.Read More

Investigators will need to be more diligent in reporting their financial interests now that the FDA is stepping up its efforts to verify financial disclosures during site inspections.Read More

Devicemakers should not rely on states to pass legislation to protect them from onerous provisions in federal healthcare overhaul bills, Josh Chafetz, a constitutional lawyer and professor at Cornell Law School, said.Read More

CDRH has been struggling with how to deal with the constant updating of devices, such as determining when new information about the risk-benefit profile of a marketed device should be considered in the premarket review of a similar device.Read More

Using Bayesian statistical methods in clinical trials could save device sponsors time and money, according to a new final guidance.Read More

EU device issues have been transferred to the Directorate-General for Health and Consumers (DG SANCO) as part of a recent reorganization of the European Commission (EC).Read More

The FDA’s proposed rule on good manufacturing practices (GMPs) for combination products needs more guidance and should better address legacy products, according to manufacturers of the products. Read More

The length of time to get marketing approval for a device and the varying levels of access to devices are among the greatest challenges facing the device industry in Europe, according to a new European Commission (EC) report.Read More

The FDA is expanding a new computer system called PREDICT to rank imports according to their risk as one element in the agency’s strategy to identify and block unsafe products from entering the country.Read More

The FDA warned Crown Health Care Laundry Services, a surgical drape pack manufacturer, for supply chain issues, audit problems and lack of documentation.Read More

CDRH is kicking off a radiation reduction initiative that could force manufacturers of imaging devices to re-design their products so they can alert healthcare professionals when radiation doses exceed recommended levels. Read More

A possible failure to evaluate complaints to determine if they qualified as medical device reports resulted in a warning letter to Victus. Read More

Industry says two draft guidances on computer-assisted detection (CADe) devices may be burdensome or unnecessary, echoing comments made at a workshop last fall that urged the FDA to redraft the guidances.Read More

Penumbra received an FDA warning letter after sales representatives kept returned product as “trunk stock” in their vehicles along with finished product.Read More

A new task force has been formed to develop guidance by the end of this year for combination diagnostic/therapeutic drug products, Elizabeth Mansfield, director of personalized medicine at CDRH’s Office of In Vitro Diagnostics, says. Read More

Premium Dental, a bite tray importer and distributor, received a warning letter for lack of complaint handling, medical device reporting (MDR) and corrective and preventive action procedures.Read More

Devicemakers spent millions of dollars lobbying Congress during the final quarter of 2009 to battle the proposed $2 billion annual device tax and a myriad of other issues.Read More

Boston Scientific has agreed to pay $1.7 billion to Cordis, a Johnson & Johnson (J&J) subsidiary, to settle patent disputes involving stent technology — a move that could change the way devicemakers protect their products, experts say.Read More

The FDA has given CareFusion permission to resume manufacturing and marketing its Alaris SE infusion pumps, lifting a 3-year-old injunction that is part of an ongoing consent decree.Read More

French devicemaker ELA Medical has been warned for not reporting adverse events that occurred outside the U.S. involving the same devices it distributes in the U.S.Read More

The FDA’s proposed 2011 budget includes new user fees for devicemakers.Read More