ARTICLES BY NICK OTTO
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![epa_publicdomain]( "Will The EPA’s Sterilizer Assessment Disrupt The Medical Device Industry?")
Will The EPA’s Sterilizer Assessment Disrupt The Medical Device Industry?11/21/2014The 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.
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![brazil_publicdomain]( "Brazil’s ANVISA Seeking Industry Feedback Following Manufacturing Inspections")
Brazil’s ANVISA Seeking Industry Feedback Following Manufacturing Inspections11/20/2014Brazil’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.
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![canadian_flag_publicdomain]( "Canada Issues New Electronic Formatting Requirements For Class III, IV Devices")
Canada Issues New Electronic Formatting Requirements For Class III, IV Devices11/19/2014Beginning 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.
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![japan_publicdomain]( "What The New Japanese Medical Device Regulations Mean For You")
What The New Japanese Medical Device Regulations Mean For You11/12/2014With 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.
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![Supreme Court On Coca-Cola Labeling Dispute]( "FDA Sued For Wrongly Detaining Devices")
FDA Sued For Wrongly Detaining Devices11/11/2014Two 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.
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Medical Device Tax At The Forefront Following Midterm Elections11/6/2014
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.
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![FDA]( "FDA Warns Cook Medical On CAPA, Documentation Procedures")
FDA Warns Cook Medical On CAPA, Documentation Procedures11/5/2014Bloomington, 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.
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![FDA EHR Pilot Program]( "FDA Expresses Commitment To Development Of Devices For Patients With Disabilities")
FDA Expresses Commitment To Development Of Devices For Patients With Disabilities11/3/2014The FDA recently emphasized its push to empower the medical device industry in studying and developing new technologies to treat patients with disabilities.
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![ebola-niaid]( "FDA Chief Details Agency Initiatives To Combat Ebola")
FDA Chief Details Agency Initiatives To Combat Ebola10/31/2014FDA Commissioner Margaret Hamburg this week further detailed the agency’s efforts in battling the Ebola outbreak that began in West Africa.
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![Australia Proposes Domestic Device Registration Using European CE Marking]( "Australian Government To Initiate Review Of Medical Device Regulations")
Australian Government To Initiate Review Of Medical Device Regulations10/30/2014A 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.
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![FDA]( "FDA Issues Emergency Use Authorization For Ebola Diagnostic Device")
FDA Issues Emergency Use Authorization For Ebola Diagnostic Device10/28/2014FDA 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.
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Have Medical Device Review Times Improved?10/28/2014
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.
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![image]( "FDA Details Labeling Requirements For MTB-Complex Testing Devices")
FDA Details Labeling Requirements For MTB-Complex Testing Devices10/24/2014Manufacturers 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.
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![Australia Proposes Domestic Device Registration Using European CE Marking]( "Australia Proposes Domestic Device Registration Using European CE Marking")
Australia Proposes Domestic Device Registration Using European CE Marking10/22/2014Australia’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.
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![fda_sign]( "FDA Must Follow Congressional Procedures When Rescinding 501(k) Clearance")
FDA Must Follow Congressional Procedures When Rescinding 501(k) Clearance10/1/2014The 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.
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![HTO FDA]( "Final FDA Guidance Details Custom Device Exemptions")
Final FDA Guidance Details Custom Device Exemptions9/26/2014Fresh guidance from the FDA details exemption processes to traditional approval requirements for manufacturers of custom medical devices.
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FDA Sets Date For Cybersecurtiy Workshop9/25/2014
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.
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![NIH_Clinical_Research_Center_aerial]( "NIH Issues Additional Funding To Study Gender Differences In Clinical Trials")
NIH Issues Additional Funding To Study Gender Differences In Clinical Trials9/24/2014The 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.
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![Tax]( "Industry Lauds Passing Of Bill To Repeal Device Tax")
Industry Lauds Passing Of Bill To Repeal Device Tax9/22/2014The House of Representatives recently voted to pass a bill that would repeal the hotly debated 2.3 percent medical device excise tax.
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![HTO FDA]( "FDA Proposes Reclassification of EPPG, PSA Devices To Class II")
FDA Proposes Reclassification of EPPG, PSA Devices To Class II9/19/2014The FDA is proposing to reclassify both external pacemaker pulse generator (EPPG) devices and pacing system analyzers (PSAs) as class II devices with special controls.
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![FDA]( "FDA Proposes New Study To Test Device Labeling Standardization")
FDA Proposes New Study To Test Device Labeling Standardization9/17/2014The FDA is taking steps to further study the feasibility of standardizing device labeling using new formats currently under development.
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Congressional Leaders Question FDA Decision To Regulate LDTs9/12/2014
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.
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![graph-249937_640]( "Medical Devices Experience Fewest Recalls Since 2012")
Medical Devices Experience Fewest Recalls Since 20129/10/2014The medical device industry saw its lowest number of recalls since 2012, according to new research from Stericycle, an industry recall consultancy.
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![nephrocheck]( "FDA Green Lights First Device To Assess Risk For Acute Kidney Injury")
FDA Green Lights First Device To Assess Risk For Acute Kidney Injury9/9/2014The 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).
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![HTO FDA]( "FDA Finalizes 510(k) Requirements For HMMD Manufacturers")
FDA Finalizes 510(k) Requirements For HMMD Manufacturers9/4/2014Manufacturers 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.
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![FDA]( "FDA Releases FAQ Guidance On UDI System")
FDA Releases FAQ Guidance On UDI System9/2/2014The 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.
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![computerscreen_dna_450x300]( "NIH Issues Final Genomic Data Sharing Policy")
NIH Issues Final Genomic Data Sharing Policy8/29/2014A 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.
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![FDA]( "FDA Guidance Advises Industry To Monitor Gender Equality In Clinical Trials")
FDA Guidance Advises Industry To Monitor Gender Equality In Clinical Trials8/23/2014The 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.
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![chinese_flag]( "China Food And Drug Administration Updates Clinical And Registration Requirements")
China Food And Drug Administration Updates Clinical And Registration Requirements8/22/2014The 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.
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![HTO FDA]( "Final Guidance Cuts Pre-Decisional IDE Review Process")
Final Guidance Cuts Pre-Decisional IDE Review Process8/22/2014The 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.
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![Sample UDI Label]( "FDA Issues UDI Guidance Tailored For Small Device Makers")
FDA Issues UDI Guidance Tailored For Small Device Makers8/18/2014The 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.
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![ScienceMedAbstract]( "Report Notes Uptick In Medtech Employment")
Report Notes Uptick In Medtech Employment8/18/2014Employment within the medical device industry remained steady in 2013, with most device-makers experiencing increases in their workforce.
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![printing3d]( "3D Printing Added To FDA’s Experiential Learning Program")
3D Printing Added To FDA’s Experiential Learning Program8/13/2014The FDA recently announced its intentions to add a new general training program component to its Experiential Learning Program (ELP).
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![FDA]( "FDA Finalizes Guidance For Home-Use Medical Devices")
FDA Finalizes Guidance For Home-Use Medical Devices8/11/2014The 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.
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![fda_sign]( "FDA Seeks Industry Feedback On Labeling Burdens")
FDA Seeks Industry Feedback On Labeling Burdens8/8/2014The FDA is seeking industry feedback on the recordkeeping burdens medical device-makers face in maintaining labels.
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![OpenFDA]( "FDA’s Regulation Of Laboratory Developed Tests On The Horizon")
FDA’s Regulation Of Laboratory Developed Tests On The Horizon8/4/2014The 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.”
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![FDA]( "FDA Finalizes 510(k) Substantial Equivalence Guidance")
FDA Finalizes 510(k) Substantial Equivalence Guidance7/31/2014The 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.
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![EU]( "European Commission Seeks Input On Safety Of Nanomaterials Used In Medical Devices")
European Commission Seeks Input On Safety Of Nanomaterials Used In Medical Devices7/30/2014The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) has opened public consultation on the use of nanomaterials in medical devices.
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![lightbulbplanningknowledgeinsight]( "Industry Leaders Address Revival Of U.S. Device Innovation")
Industry Leaders Address Revival Of U.S. Device Innovation7/29/2014Recently, an executive from industry giant Edwards Lifesciences addressed a congressional committee on the dwindling state of medical device innovation in the United States.
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![CMS logo]( "Proposed Changes To Sunshine Act Could Mean Added Costs For Device-Makers")
Proposed Changes To Sunshine Act Could Mean Added Costs For Device-Makers7/28/2014The 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.
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![OpenFDA]( "New FDA Curriculum To Educate Innovators On Approval Process")
New FDA Curriculum To Educate Innovators On Approval Process7/23/2014The 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.
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![HTO FDA]( "FDA Rejects Petition Of Controversial Transvaginal Mesh Products")
FDA Rejects Petition Of Controversial Transvaginal Mesh Products7/21/2014The FDA has rejected a call for a total ban on transvaginal mesh products filed by consumer advocacy group Public Citizen.
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![FDA Sign]( "FDA Issues Fresh Draft Guidance On 510(k) Benefit-Risk Review")
FDA Issues Fresh Draft Guidance On 510(k) Benefit-Risk Review7/21/2014Manufacturers 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.
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![Indian_National_Flag]( "India’s CDSCO Clarifies Device Trial Requirements, Categories")
India’s CDSCO Clarifies Device Trial Requirements, Categories7/17/2014India’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.
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![FDA]( "FDA Downgrades Headache Treatment Devices To Class II")
FDA Downgrades Headache Treatment Devices To Class II7/16/2014The 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.
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House Subcommittee Pushes ‘Patent Troll’ Bill Forward7/15/2014
A House of Representatives panel has approved a draft of a bill that would rein in abusive patent demand letters.
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![OpenFDA]( "FDA Looks To Further Develop Pediatric Safety, Efficacy")
FDA Looks To Further Develop Pediatric Safety, Efficacy7/14/2014It’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.
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![FDA]( "Senators Urge Approval Of FDA Laboratory-Developed Test Draft Guidance")
Senators Urge Approval Of FDA Laboratory-Developed Test Draft Guidance7/11/2014Five 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.
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![OpenFDA]( "FDA Five-Year Plan Focuses On Globalization, Safety")
FDA Five-Year Plan Focuses On Globalization, Safety7/8/2014The 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.
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![EU]( "Are Unannounced Audits The New Norm For EU Devicemakers?")
Are Unannounced Audits The New Norm For EU Devicemakers?7/3/2014The 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).
Nick Otto
Nick Otto is a contributing writer for Med Device Online. He has covered global regulatory, legislative, and legal news affecting executives in the medical device and biotech industries in both established and emerging markets.