Top Device Stories

The European Commission is seeking input from its scientific committees on the relationship of synthetic biology (SB) to the genetic modification of organisms, its implications for human health and the major gaps in knowledge necessary for performing a reliable risk assessment.Read More

Industry will get much of what it asked for in the unique device identifier final rule, which is expected to be released around its June 19 deadline.Read More

The UK’s Medicines and Healthcare products Regulatory Agency is seeking views on its approach to implementing the European Commission’s regulations on use of animal tissues in medical devices and electronic labeling.Read More

A House subcommittee Wednesday voted to advance appropriations legislation boosting the FDA’s fiscal 2014 funding by nearly $100 million over post-sequester levels, but the budget bill doesn’t come close to meeting the agency’s initial $4.7 billion request.Read More

Beginning this month, devicemakers in France must begin reporting all payments and other benefits to healthcare professionals in excess of €10, including tax — about US $12.87.Read More

An FDA move for stronger oversight of laboratory-developed tests (LDTs) is facing significant industry pushback.Read More

Six years after the EU’s advanced therapy medicinal products regulation went into effect, only one tissue-engineered product has been granted approval, Eucomed says in comments criticizing the regulation’s approach to the evaluation of ATMP products.Read More

EU lawmakers seemed lukewarm, at best, on the idea of subjecting the riskiest medical devices to a U.S.-style premarket approval mechanism during a May 29 debate by members of the Committee on the Environment, Public Health and Food Safety.Read More

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 at MedCon 2013.Read More

CooperSurgical, doing business as Lone Star Medical Products, failed to use its MDR determination form for a series of four complaints about vaginal lacerations that required suturing, a recent warning letter reveals.Read More

While FDA financial disclosure rules require investigators to provide sponsors with their financial information, at the end of the day “the buck stops” with the sponsor, a legal expert says.Read More

CDRH has warned the institutional review board at a Winchester, Va., hospital after an inspection found the IRB repeatedly made changes to device clinical trials without going through the proper procedures.Read More

To improve engagement between the European Medicines Agency (EMA), drugmakers and scientific committees, the agency is putting in motion planned changes discussed late last year.Read More

The FDA’s proposed rule on use of overseas clinical trial data for devices should not apply informed consent provisions to in vitro diagnostic studies that use de-identified samples, Roche says in comments to the rule.Read More

When shopping for an IRB, sponsors should pay particular attention to whether the review board offers a single point of contact and whether that contact is qualified to handle the sponsor’s needs.Read More

A recent FDA draft guidance on distinguishing product recalls from product enhancements has met strong industry resistance, with many commenters asking the agency to withdraw the guidance and try again.Read More

The FDA has updated its draft guidance on best practices for conducting safety studies using electronic healthcare data sets after receiving more than 400 comments on its recommendations.Read More

The FDA is hiring two new executives to restructure its Office of Information Technology (OIT) and address criticism by government auditors that efforts to integrate the agency’s vast IT system have taken far too long.Read More

An FDA warning letter to CORPAK MedSystems calls out the company’s handling of defective stylets and complaints related to their use.Read More

Durable medical equipment suppliers were on the defensive during a Wednesday Senate subcommittee hearing on alleged improper marketing tactics targeting Medicare beneficiaries.Read More

The FDA has warned a Finnish maker of x-ray devices that lacked procedures on design control, quality audits and training.Read More

An industry group has sued the Department of Health and Human Services, alleging that recent changes to federal orthotic and prosthetic payment rules shortchange providers.Read More

ACell, a maker of tissue and organ repair products, received an FDA Form 483 noting that several design inputs were identified from scientific articles and promotional materials for similar devices.Read More

A rare enforcement action against a mobile app developer for failing to get 510(k) clearance may have a positive effect by setting boundaries for the rest of the field, one mHealth expert says.Read More

An FDA Form 483 to Alma Lasers documents problems with complaint records and procedures for reviewing and evaluating complaints.Read More

Australia’s Therapeutic Goods Administration is recommending to move forward with a proposal that would increase the number of mandatory audits for high-risk devices, make transparent all device regulatory decisions and allow all but Class IV in vitro diagnostic devicemakers to use non-TGA conformity assessments.Read More

SCM True Air Technologies, a maker of therapeutic mattresses, fielded a four-observation Form 483 related to its handling of complaints and manufacturing changes. Read More

Healthcare providers experience the most frequent battery problems with large-volume infusion pumps and would like manufacturers to add green, yellow and red LED lights that change color when the battery status changes.Read More

Strong buy-in at the top is essential to developing and maintaining a successful compliance program, experts told attendees at the Medical Device Manufacturers Association meeting last month.Read More

Goldman Sachs last week announced plans to invest about $20 million in Indian devicemaker BPL Medical Technologies, marking one of the largest medtech investments made to date in an emerging market.Read More

Deborah Autor, U.S. Food and Drug Administration deputy commissioner for global regulatory operations and policy, is leaving to join the regulatory policy team at generic drugmaker Mylan.Read More

The FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds.Read More

Brazil is streamlining its good manufacturing practice requirements, replacing RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostics with a single regulation, RDC 16/2013.Read More

CDRH Friday released two guidances aimed at clarifying the center’s appeals process and bringing it in line with last summer’s FDA Safety & Innovation Act.Read More

The Philippines has completed the transfer of regulatory authority for medical devices from the Food and Drug Administration to the Center for Device Regulations, Radiation Health and Research.Read More