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Top Device Stories


EU ‘Roadmap’ Offers Window on Possible MDD Reforms

A group of medical device experts from EU member states would oversee device regulation in the union, according to one proposal in a recent “roadmap” released by the European Commission’s Directorate-General for Health & Consumers.Read More
 

Congressional Democrats Call for Hearings on Hazardous Medical Devices

House Democrats are urging the Committee on Energy and Commerce to hold hearings on whether the FDA and device industry are doing all they can to protect consumers from unsafe products.Read More
 

Medical Devices: Looking Ahead to 2012

Whether it’s regulatory reforms in the U.S. and Australia, new regulatory frameworks in emerging economies, regulatory guidances and harmonization activities or medtech taxes by cash-strapped governments, IMDRM spanned the globe in 2011 to bring readers useful, up-to-date information on international medical device regulations.Read More
 

Guidance on Combination Knee Products Stresses Primary Endpoints

Primary endpoints for Phase III clinical trials of combination products used to repair knee cartilage should be either improvement in physical function or reduction of pain, according to an FDA final guidance.Read More
 

FDA Took Global View of GMPs, Tweaked Transparency in 2011

As promised, the FDA last year moved to tighten up loose links in the global device supply chain while addressing criticism that agency decisionmaking is too often opaque.Read More
 

RI Consultants Gets 483 for Weak Device History Record Procedures

RI Consultants, a maker of radiotherapy devices, was handed a Form 483 for a dearth of device history records and for not identifying the training needs of personnel at its Nashua, N.H., plant.Read More
 

Unapproved “Custom” Products Land DePuy a Warning Letter

The FDA slapped Johnson & Johnson’s DePuy Orthopaedics with a Dec. 8 warning letter for distributing devices without premarket approval.Read More
 

Stryker Settles for $15 Million in Bone Filler Misbranding Case

Stryker’s Biotech division has agreed to pay $15 million to the U.S. government to settle an illegal scheme to promote off-label use of its OP-1 implant and OP-1 putty in combination with Calstrux, a bone-void filler. Read More
 

FDA Report: Devicemakers Should Submit Draft Guidance to Agency

An FDA working group on guidance development says the agency should encourage devicemakers to submit draft guidance rather than just guidance topics to help the agency understand the issues and expedite guidance development.Read More
 

De Novo Draft Comments Find Flaws in Guidance

FDA’s draft guidance on a de novo approval process for low-risk devices that are not substantially equivalent to anything on the market may prove too cumbersome to be useful.Read More
 

Midmark Warned Over CAPAs, Supplier Controls

The FDA has warned Midmark after the devicemaker failed to strengthen corrective and preventive action procedures at its Versailles, Ohio, facility as the agency urged in an earlier Form 483.Read More
 

FDA Misses MDUFA Deadline, Urged to Resolve Differences With Industry

Ranking members of the House and Senate committees charged with reauthorizing user fee legislation for medical devices used the FDA’s Jan. 13 delivery of three drug user fee agreements to nudge devicemakers and the FDA toward promptly issuing their own commitment letter.Read More
 

FDA Report: Devicemakers Should Submit Draft Guidance to Agency

An FDA working group on guidance development says the agency should encourage devicemakers to submit draft guidance rather than just guidance topics to help the agency understand the issues and expedite guidance development. Read More
 

Adverse Events, Reporting Problems Earn Warning for J&J Unit

The FDA has issued a warning letter to Johnson & Johnson subsidiary Animas for repeated failure to report adverse events with its insulin pumps.Read More
 

Off-Label Communications Policy Review Underway at U.S. FDA

In response to a citizen petition, the U.S. Food and Drug Administration is seeking public input on how it should regulate scientific exchanges on off-label uses for medical products. Read More
 

Industry: PIP Breast Implant Fears Highlight Need for EU Controls

Confusion stemming from the recent media blitz about faulty breast implants made by a defunct French company underscores the need for a new regulatory framework for medical devices in Europe, industry group Eucomed says.Read More
 

U.S. FDA Guidance Offers Off-Label Roadmap for the Internet Age

Devicemakers responding to unsolicited requests for off-label product information are urged to keep conversations private and specific to the requester’s inquiry, according to a new draft U.S. Food and Drug Administration guidance.Read More
 

Thoratec Faces LVAD Share Loss, Plans Heart Pump 510(k)

Thoratec could lose its dominance in the U.S. left-ventricular assist device (LVAD) market this year if the FDA approves competitor Heartware’s LVAD pump, analysts say.Read More
 

U.S. Sees Pluses in EU System as It Considers Device Review Redesign

For some devices, laboratory testing and computer modeling may offer better product review data than clinical trials, a U.S. Food and Drug Administration (FDA) official said.Read More
 

FDA Asks TV Mesh Manufacturers to Conduct Postmarket Studies

Surgical mesh manufacturers have until Feb. 3 to submit their plans to the FDA for conducting postmarket studies under Section 522 of the 1938 FD&C Act.Read More
 

Bill Could Facilitate Tracking of Implants Approved Via 510(k)

If a newly submitted bill is passed into law, it could force devicemakers to conduct more postmarket studies after 510(k) clearance.Read More
 

MDUFA Agreement Progresses, But Sticking Points Remain

FDA-industry negotiations to reauthorize the Medical Device User Fee Act (MDUFA) went down to the wire last week, as CDRH seemed destined to miss a Jan. 15 due date for sending a commitment letter to Congress.Read More
 

Tanzania Outlines Devicemaker Obligations in Clinical Trials

The Tanzania Food and Drugs Authority (TFDA) requires formal reports for serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) in clinical trials conducted in the country, according to a draft guideline for sponsors, investigators and contract review organizations.Read More
 

FDA Report Encourages Industry to Submit Draft Guidance

An FDA working group on guidance development says the agency should encourage devicemakers to submit draft guidances rather than just proposed topics to help the agency understand the issues and expedite guidance development. Read More
 

TGA Clarifies Advisory Committee Conflict-of-Interest Rules

Medical device advisory committee members should disclose any potential conflict of interest prior to each meeting, according to a final guideline by Australia’s Therapeutic Goods Administration (TGA).Read More
 

Poor Tracking of Pediatric Devices Undermines Effect of FDAAA

The FDA fails to consistently track approvals of pediatric devices, despite a congressional mandate to do so, a Government Accountability Office (GAO) report concludes.Read More
 

Industry Disappointed by TGA’s Weak Stand on Ethical Codes

Australian devicemakers are criticizing a Therapeutic Goods Administration (TGA) report on regulatory reform that fails to endorse a common industry conduct code.Read More
 

Light-Tech Warning Letter Cites Unapproved Product

A Florida surgical lamp company has received a warning letter over its lack of a PMA for one product line, among other shortcomings.Read More
 

GHTF Guidance Clarifies Different FCAs for Devices

The Global Harmonization Task Force’s (GHTF) Study Group 2 recommends a three-tiered classification system for field corrective actions (FCAs), according to draft guidance.Read More
 

IOM Argument to End 510(k)s Is Defended in FDLI Report

The FDA should establish a new standard for premarket clearance to tell the difference between products that can be approved based on predicate devices alone and those that need more rigorous postmarket approval, says one legal expert. Read More
 

Ontario Pilot Using Premarket, Evidence-Based Model to Launch Medtech

A public-private partnership hopes to speed novel medical devices from development to market penetration in Ontario by identifying needed improvements before the premarket approval phase.Read More
 

EU Proposes Centralized Expert Group to Oversee Medical Devices

A group of medical device experts from EU member states would oversee device regulation in the union, according to one proposal in a recent “roadmap” released by the European Commission’s Directorate-General for Health & Consumers.Read More
 

Malaysia Adopts Device Regulatory Scheme, Issues Guidances for IVDs

Malaysia’s Medical Device Control Division (MDCD) has issued a series of companion draft guidances on in vitro diagnostic (IVD) medical devices in anticipation of a new device regulatory regime set to take effect in December 2012. Read More
 

FDA Requests Devicemakers’ Input on Off-Label Communication

In response to a citizen petition, the FDA is seeking public input on how it should regulate scientific exchanges on off-label uses for medical products.Read More
 

EU “Roadmap” Offers Window on Possible MDD Reforms

A group of medical device experts from EU member states would oversee device regulation in the union, according to one proposal in a recent “roadmap” released by the European Commission’s Directorate-General for Health & Consumers.Read More