Top Device Stories

In vitro diagnostic manufacturers can expect a “quantum leap” in regulatory burden if the European Commission’s proposed IVD regulation is adopted — a 180-degree turn in notified body requirements, a device legal expert says.Read More

The European Commission should specify provisions for inspecting clinical trials of in vitro diagnostic devices and not leave oversight to the discretion of EU member states, a draft report by a member of Parliament says.Read More

Devicemakers that want their voices heard as the European Parliament considers reforms to medical device regulation need to speak up immediately, experts urge.Read More

The FDA’s failure to release a final rule on unique device identification by last week’s deadline could delay efforts by other branches of government to put UDIs into use, according to lawmakers.Read More

The International Medical Device Regulators Forum last month unveiled its long-awaited plan for device identification, pushing for a “highly interoperable” and harmonized system to globally track medical devices. Read More

CareFusion has reached an agreement in principle to pay the government $41 million, resolving investigations into sales and marketing of its ChloraPrep skin preparation.Read More

Oral arguments are set for May 15 in a suit pending in the D.C. Circuit Court of Appeals that seeks to overturn the U.S. Securities & Exchange Commission’s (SEC) conflict minerals disclosure requirement.Read More

The FDA has warned two makers of speech therapy devices for quality system issues, as well as for lacking device approvals or clearances.Read More

New proposed Australian legislation intended to bring sunshine to financial transactions between drugmakers and physicians has medtech groups concerned about future inclusion.Read More

The FDA’s Oncologic Drugs Advisory Committee Thursday voted 16-0 to reject a drug-device combination product for treating a deadly form of liver cancer, citing concerns with safety and lack of supporting data.Read More

Australian devicemakers are asking the government to include guidelines specifically covering mobile medical apps and apps for health and wellbeing in any policy on mobile privacy.Read More

The Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule that would update fiscal 2014 Medicare payment rates for certain devices and technologies used during inpatient stays at hospitals. Read More

The Philippines Food and Drug Administration last month adopted a harmonized adverse event reporting system for defective or unsafe medical devices and other FDA-regulated products.Read More

CINCINNATI — The FDA is considering a more flexible interpretation of its quality system regulations to help devicemakers more effectively respond to post-inspection Form 483s and reverse a nearly decade-long trend of little improvement in enforcement actions, CDRH Office of Compliance Director Steve Silverman said Wednesday at MedCon 2013.Read More

The use of a proposed trans-Tasman early warning system for devices and drugs should be limited to generic problems and when sponsor or manufacturer communications have been deemed ineffective, the Medical Technology Association of Australia says.Read More

An FDA final guidance should make it easier for in vitro diagnostic manufacturers to migrate approved assays to new platforms by outlining the “least burdensome” scientific and regulatory paths to use when doing so.Read More

The FDA argues that it’s more than worth it, but the agency also acknowledges that compliance with its Final Rule on UDI (Unique Device Identification) won’t be a compliance slam dunk.Read More

Device trade groups are pushing for several harmonization provisions, including a single-audit system, to make it into the planned Transatlantic Trade and Investment Partnership (TTIP) Agreement.Read More

A new FDA draft guidance instructs sponsors on how to use International Organization for Standardization (ISO)-10993 Part 1 to test the potential toxicity of devices that come into direct or indirect contact with the body.Read More

The U.S. Food and Drug Administration’s medical device center is soliciting comments on how it handles appeals, in anticipation of combining a 1998 guidance on appeals and complaints and one from 2001 on the Medical Devices Dispute Resolution Panel.Read More

Consumers Union is pushing the FDA to finalize a proposed rule that would require PMA approval for metal-on-metal (MoM) hip implants.Read More

Medical devices intended for use in the home should be almost as easy to figure out as smartphones, an FDA official said Tuesday. Read More

Malaysia’s Medical Device Control Division began accepting applications Feb. 18 from parties interested in registering as conformity assessment bodies (CAB). Read More

A final agreement for a Trans-Pacific Partnership (TPP) should establish a fair, predictable process for medical device reimbursement, AdvaMed says.Read More

All but three EU member states signed an international agreement Feb. 19 to create a Unified Patent Court.Read More

Abbott is recalling U.S. supplies of its FreeStyle InsuLinx blood glucose meters, due to a problem with readings at very high glucose levels — the second such recall by a diabetes product maker in a month.Read More

Vascular Solutions Zerusa has launched a nationwide Class I recall of Guardian II and Guardian II NC hemostasis valves used in catheterization procedures. Read More

Spacelabs Medical has voluntarily recalled anesthesia workstations and service kits manufactured and distributed between Oct. 31, 2012, and Jan. 15, 2013.Read More

Devicemakers should see action later this spring on early feasibility studies and a unified postmarket surveillance system, CDRH Director Jeffrey Shuren told a town hall session at the MDMA annual meeting.Read More

Legislators and advocates on hand at the Medical Device Manufacturers Association’s annual conference in Washington, D.C., on April 16 agreed that repeal of the 2.3 percent medical device excise tax that took effect Jan. 1 is within reach.Read More

The UK’s Medicines and Healthcare products Regulatory Agency issued a safety warning for Abbott Vascular’s MitraClip mitral valve repair device, stating the clip may not deploy successfully if the physician turns a knob on the clip delivery system in the wrong direction during implantation.Read More

Ad-Tech Medical Instrument is voluntarily recalling Macro Micro Subdural Electrodes manufactured between June 2006 and March 2012, because the products are not flush with the silastic surface.Read More

FDA inspectors evaluating the adverse event reporting programs at medical device companies are finding a lot of the same problems over and over again, says Sharon Kapsch, chief, MDR Policy Branch, Office of Surveillance and Biometrics, CDRH.Read More

The International Medical Device Regulators Forum last week unveiled its long-awaited plan for device identification, pushing for a “highly interoperable” and harmonized system to globally track medical devices.Read More

The Korea Medical Devices Industrial Cooperative Association recently joined the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association as its ninth member.Read More