Top Device Stories

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

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

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

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

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, 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

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

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

An FDA working group on guidance development says the agency should encourage devicemakers to submit draft guidance rather than just guidance topics to help the agency understand the issues and expedite guidance development.Read More

FDA’s draft guidance on a de novo approval process for low-risk devices that are not substantially equivalent to anything on the market may prove too cumbersome to be useful.Read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

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

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

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

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

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

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

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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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’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

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

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