The Chemical Assessment Advisory Committee (CAAC) of the Environmental Protection Agency’s Science Advisory Board (SAB) met recently to evaluate the agency’s Integrated Risk Information System (IRIS) draft assessment of the carcinogenic effects of ethylene oxide (EO). The final draft conclusion on the risks of EO could have major implications for medical device makers.
Brazil’s medical device regulatory body, the Agência Nacional de Vigilância Sanitária (ANVISA), recently announced that it will now be accepting industry feedback following Brazilian Good Manufacturing Practice (BGMP) inspections.
Beginning Dec. 1, 2014, Health Canada, the country’s medical device regulator, is going to require electronic submissions for many high-risk Class III and Class IV medical device license applications.
With a comprehensive regulatory framework for medical devices set to take effect on Nov. 25, Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has made some changes that need to be addressed for device makers looking to remain compliant in the Asian market.
Two leg brace distributors recently filed lawsuits against the FDA, claiming that the agency improperly detained shipments of their devices after determining the products required premarket clearance.
With the Senate being swept up in red, many are speculating that aspects of the Affordable Care Act (ACA) will be amended, particularly the highly contested Medical Device Excise Tax.
Bloomington, Ind.-based Cook Medical is on the FDA’s radar following a warning letter calling on the device maker to fix a slew of quality problems at its Indiana facility.
The FDA recently emphasized its push to empower the medical device industry in studying and developing new technologies to treat patients with disabilities.
FDA Commissioner Margaret Hamburg this week further detailed the agency’s efforts in battling the Ebola outbreak that began in West Africa.
A group of experts will review the Australian Therapeutic Goods Administration’s (TGA) framework for the regulation of medical devices and pharmaceuticals, according to a recent government announcement.
FDA officials recently issued an emergency use authorization (EUA) for Utah-based BioFire Defence’s FilmArray Biothreat-E test for the detection of the Ebola Zaire virus. The test runs and can only be used with the device maker’s FilmArray systems.
A new look at the FDA’s medical device review times from the California Healthcare Institute (CHI), in partnership with The Boston Consulting Group, points to a modest improvement in the agency’s review times.
Manufacturers of nucleic acid-based in vitro diagnostic devices used for the detection of Mycobacterium tuberculosis complex (MTB-complex) should take a variety of steps to prevent false-negative and false-positive results, according to recommendations from an FDA Class II special controls guidance.
Australia’s prime minister recently issued a new proposal that would allow Australian device makers to register “routine” medical devices using conformity assessment certifications acquired from European notified bodies.
The FDA’s ability to reclassify devices was restricted by a federal appeals court, which issued a ruling that says the agency does not have the inherent authority to reclassify devices.
Fresh guidance from the FDA details exemption processes to traditional approval requirements for manufacturers of custom medical devices.
The FDA is seeking public input on the cybersecurity of medical devices and has scheduled for next month a two-day public workshop in collaboration with the Department of Homeland Security.
The National Institutes of Health (NIH) is investing $10 million in additional funding for scientific trials to encourage researchers to consider gender in their preclinical and clinical studies.
The House of Representatives recently voted to pass a bill that would repeal the hotly debated 2.3 percent medical device excise tax.
The FDA is proposing to reclassify both external pacemaker pulse generator (EPPG) devices and pacing system analyzers (PSAs) as class II devices with special controls.
The FDA is taking steps to further study the feasibility of standardizing device labeling using new formats currently under development.
Congressional leaders this week grilled FDA officials on the agency’s legal authority to regulate lab-developed tests (LDTs), asking if new requirements would trigger additional costs to laboratories, and whether the FDA itself had the necessary resources to take on the task.
The medical device industry saw its lowest number of recalls since 2012, according to new research from Stericycle, an industry recall consultancy.
The FDA recently allowed marketing for a first-of-its-kind device used in determining if certain critically ill, hospitalized patients have an imminent risk of developing acute kidney injury (AKI).
Manufacturers of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs) should be ready to justify their performance characteristics in 510(k) or de novo submissions, according to recently finalized FDA guidance.
The FDA released new guidance on the unique device identifier (UDI) system in the form of frequently asked questions (FAQs). The guidance summarizes key aspects of the agency’s UDI final rule, taking into consideration industry comments and questions.
A new final policy from The National Institutes of Health (NIH) will give scientists of government-funded research six months to load any collected genomic data into a government-stablished database. The policy will apply to all researchers with NIH-funded grants who are conducting large-scale human and non-human projects that generate genomic data.
The FDA recently released final guidance advising device makers performing clinical trials to consider the gender distribution of study participants throughout various points of a study.
The China Food and Drug Administration (CFDA) last month released revisions (in Chinese) to administrative measures that, on Oct. 1, will affect the way medical devices are registered in the country.
The FDA’s recent final guidance encourages device makers to perform clinical studies using the agency’s Investigational Device Exemption (IDE) regulations, but nixes a proposed program aimed at speeding the clinical assessment process.
The FDA recently issued guidance advising small medtech companies on how to comply with the agency’s unique device identification (UDI) system, which requires device makers to label their products with codes aimed at improving product recalls, organizing electronic health records, and deterring counterfeiting efforts.
Employment within the medical device industry remained steady in 2013, with most device-makers experiencing increases in their workforce.
The FDA recently announced its intentions to add a new general training program component to its Experiential Learning Program (ELP).
The FDA recently released guidance for manufacturers on design considerations for medical devices intended for use at home to address the unique risks associated with the domestic environment.
The FDA is seeking industry feedback on the recordkeeping burdens medical device-makers face in maintaining labels.
The FDA recently announced that it is going to begin regulating medical laboratory testing, including companion diagnostics and laboratory developed tests (LDTs). In the statement, the agency stated that tests used to make important treatment decisions must be inspected to provide “accurate, consistent and reliable results.”
The FDA recently released final guidance addressing key issues in the agency’s 510(k) clearance program, describing in detail the critical decision points in the 510(k) review process.
The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) has opened public consultation on the use of nanomaterials in medical devices.
Recently, an executive from industry giant Edwards Lifesciences addressed a congressional committee on the dwindling state of medical device innovation in the United States.
The Centers for Medicare & Medicaid Services (CMS) recently proposed four changes to the Physician Payment Sunshine Act’s transparency rules that could result in additional costs for medical device manufacturers.
The FDA is hoping to help industry better navigate the labyrinth of its medical device regulatory approval process by offering a free, university-level regulatory training program.
The FDA has rejected a call for a total ban on transvaginal mesh products filed by consumer advocacy group Public Citizen.
Manufacturers submitting 510(k)s may now need to show FDA reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device.
India’s Central Drugs Standard Control Organization (CDSCO) issued notices last week clarifying several categories and regulatory requirements for devices that would be regulated under the same requirements that drugs face via India’s Drugs and Cosmetics Act of 1940.
The FDA has issued a final reclassification notice that eases regulatory requirements for manufacturers of neurostimulators used to treat headaches, which should speed the process of getting those devices to market.
A House of Representatives panel has approved a draft of a bill that would rein in abusive patent demand letters.
It’s been a busy few weeks for the FDA, and the agency recently released another forward-thinking plan on ways it plans to enhance the safety and study of products used in treating pediatric populations.
Five Democratic senators are urging the U.S. Office of Management and Budget (OMB) to approve draft guidance developed by the FDA to better regulate laboratory tests used in the detection of common ailments.
The FDA has laid out its strategic priorities for the next five years, including plans to increase its inspection and enforcement activities with its international counterparts.
The European Employment, Social Policy, Health, and Consumer Affairs (EPSCO) Council recently discussed the actions taken on behalf of the European Commission and member states with regard to the current level of confidence consumers have with the industry following the breast implant scandal by the now defunct Poly Implant Prothèse (PIP).