Top Device Stories

China is expected to begin amending its current medical device rules this year, as part of its 12th five-year plan to update its drug and device regulations, according to a panel of China experts at the Food and Drug Law Institute’s annual conference in Washington, D.C.Read More

An FDA final rule with stronger restrictions on the work of disqualified trial investigators takes effect May 30 and nearly mirrors an April 2011 proposed version that received little stakeholder feedback.Read More

CINCINNATI — Fears over a draft guidance on submitting 510(k)s for product alterations may be overblown, but industry and regulatory experts agree it changes the status quo.Read More

Singapore’s Health Sciences Authority is easing the registration process and reducing fees for about 70 percent of medical devices, in a bow to industry concerns about the cost of registering devices there.Read More

CINCINNATI — Regulatory advances made during the Innovation Pathway 2.0 project to develop new treatments for end-stage renal disease may quickly be rolled throughout CDRH, center Director Jeffrey Shuren said Wednesday at the FDA/Xavier University MedCon Conference here.Read More

Concerns over who will take over as the Drug Controller General of India (DCGI) in mid-May are leading some industry observers to worry about another backlog in medical device import licenses and registrations.Read More

Cross-border sharing of devicemaker audit results should be easier, thanks to a standardized nonconformity grading system developed by the Global Harmonization Task Force’s (GHTF) Study Group 3.Read More

Lax documentation of testing failures and inadequate design history files for Novalung’s surgical Lung Assist device have earned the German company an FDA warning letter. Read More

The European Commission is preparing guidance to assist notified bodies during inspections of facilities where CE-marked medical devices are made.Read More

Trial sponsors should notify the FDA about all adverse events brought to their attention by data monitoring committees (DMC), regardless of whether the safety issue is “serious” or not, according to an agency guidance.Read More

A Dutch proposal to tighten device vigilance in the EU would intensify inspections of devicemakers that operate internationally and organize surveillance around the complete life cycle of specific product lines.Read More

A new government report argues the agency’s sluggishness in integrating legacy IT systems is limiting regulatory performance.Read More

As fallout from the defective PIP breast implant imbroglio continues, a European Parliament health committee is calling for tough new regulatory controls, including the creation of a premarket authorization system for certain categories of medical devices — an idea that brought immediate kickback from industry.Read More

The FDA is stepping up its handling of device and drug cargo thefts, creating a cargo theft response team (CTRT) to assess companies’ action plans after a theft occurs.Read More

A Senate health committee approved its version of an omnibus FDA user fee bill Wednesday, sending it to the Senate floor for a vote as early as next month.Read More

By a lopsided vote, the FDA’s Circulatory System Devices Panel Wednesday recommended approval of the HeartWare Ventricular Assist System (HVAS), in what could be an early sign of more tolerance by FDA reviewers toward study designs other than traditional double-blind clinical trials.Read More

Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials.Read More

Large device companies may put less effort into environmentally sustainable business practices than counterparts in other industries because they already are seen as benefiting the public. Read More

Starting June 5, devicemakers audited according to internationally harmonized regulatory standards could be spared some annual FDA inspections, under a pilot program described in a final guidance. Read More

Stryker’s global revenues grew 7.2 percent to $2.2 billion in the 2012 first quarter, bolstered by a 12.4 percent jump in sales of neurotechnology and spine devices. Read More

The FDA is stepping up its handling of device and drug cargo thefts, creating a cargo theft response team (CTRT) to assess companies’ action plans after a theft occurs.Read More

Endotec was left holding a Form 483 after FDA investigators found shortcomings with the orthopedic devicemaker’s procedures for validating and revalidating medical implants. Read More

A bulky new Senate bill intended to boost transparency of FDA operations is merely a splashy suite of ornamental add-ons that lack key metrics for success, a former agency executive says.Read More

The potential for hacking into software-operated medical devices could pose a serious patient safety risk, a board convened by the National Institute of Standards and Technology (NIST) maintains.Read More

Thoratec is voluntarily recalling lots of its HeartMate II Left Ventricular Assist System after receiving multiple reports of product parts falling off during x-rays and surgeries, the FDA says.Read More

Stakeholders agree on the majority of the Medical Device User Fee Act (MDUFA) reauthorization legislation now before Congress, but that didn’t make a House health subcommittee hearing on device and drug user fees smooth sailing.Read More

Infimed, a maker of software and specialized hardware for medical imaging, does not always review all acceptance records and packaging checklists before releasing product for shipment, a Form 483 for the company’s Liverpool, N.Y., plant states.Read More

User fees for medical device license and renewal rose 2 percent in Canada, effective April 1.Read More

Design validation deficiencies at Boehringer Laboratories’ Phoenixville, Pa., plant have landed the company an FDA Form 483.Read More

The FDA should revise draft off-label guidance to ensure devicemakers can respond immediately to unsolicited questions on off-label uses posed in public forums, industry maintains.Read More

Lucero Medical, an Ohio-based maker of vertebral body replacement devices, has been warned for lacking a slew of basic manufacturing procedures and for various 510(k) clearance violations. Read More

A scientific journal has rejected St. Jude Medical’s demand that it retract a report linking two of its heart leads with patient deaths.Read More

German devicemaker I.E.M. was hit with a warning letter after FDA investigators found shortcomings with medical device report (MDR) procedures and an array of quality “nonconformities” during a recent inspection of the company’s Stolberg, Germany, facility.Read More

An FDA advisory panel unanimously recommended approval of a new tool for detecting breast cancer, but advised against Class I status for a preamendment device used for the same purpose.Read More

The FDA is on track to issue final rules this year on adverse event reporting and cGMPs for device-drug combinations, according to Kristina Lauritsen, a scientific reviewer in the agency’s Office of Combination Products (OCP).Read More