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Top Device Stories


China to Amend Device Regs This Year, New GMP Compliance Rules Anticipated

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
 

Stricter Investigator Disqualification Standards Go Into Effect This Month

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
 

Reconstructing 510(k) Decisions Key to New Guidance

CINCINNATI — Fears over a draft guidance on submitting 510(k)s for product alterations may be overblown, but industry and regulatory experts agree it changes the status quo.Read More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

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
 

Innovation Pathway Advances May Be Expanded Throughout Agency

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
 

India: Power Vacuum at CDSCO Blamed for Slowdown in Device Import Licenses

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
 

GHTF Proposes Risk-Based Tool for Harmonizing Device Audits

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
 

Lung Assist Maker Warned on Lacking Documentation

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
 

EC Guidance for Notified Bodies on Device Facility Inspections Expected Soon

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

Big or Small, FDA Wants to Hear About All Trial-Related AEs

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
 

Dutch Reply to Dalli Acton Plan Offers Clues to How MDD Recast May Shape Up

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
 

FDA IT Update Efforts Are Slow, Poorly Organized, GAO Finds

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

European Parliament Calls for Premarket Authorization System in Wake of PIP

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
 

FDA to Weigh Devicemakers’ Cargo Theft Response Plans, New SOP States

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
 

MDUFA Clears Senate HELP Committee, House Reschedules Markup for May 8

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
 

HeartWare VAS Gets Panel Nod Despite Safety, Data Concerns

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
 

Synthes Slapped With Wrongful Deaths Suit, FDA Warning Letter

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 Devicemakers Less Green Than Counterparts in Other Industries

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
 

Pilot Would Reduce Audit Frequency Using Harmonized Regulations

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 First-Quarter Growth Spurred By Strong Neurotech, Spine Sales

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
 

FDA to Weigh Devicemakers’ Cargo Theft Response Plans, New SOP States

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 Gets 483 for Sterilization, Validation Shortcomings

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
 

Senate FDA Reform Bill More Flash Than Action, Expert Says

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
 

NIST Panel: FDA Should Regulate Device Cybersecurity, Hacking Risks

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 Recalls Heart-Disease Device Following FDA Warning

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
 

MDUFA: Despite Broad Agreement, 510(k) Safety Concerns Remain

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
 

Lack of Defined Quality Assurance Procedures Land Infimed a Form 483

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
 

Device User Fees Tip Up in Canada, Agency Criticized for Missed Goals

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

Boehringer Laboratories Gets 483 on Design Validation Lapses

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

Industry: Off-Label Rules Mustn’t Rule Out Public Forum Discussions

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
 

Maker of Spine Replacement Systems Warned for Procedural Shortcomings

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
 

Journal Stands by St. Jude Leads Study; Medtronic Pulled into Fray

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
 

Maker of Blood Pressure Monitors Gets Warning for Quality Deficiencies

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
 

Breast Cancer Ultrasound Device Gets Favorable Panel Recommendation

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
 

OCP: Expect Final Rules on GMPs, Adverse Events by Year’s End

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