This document provides an overview and guidance for firms on consumer product recalls and CPSC compliance. It discusses the recall process, from initial reporting of a potential defect to ongoing monitoring and disposal of recalled products. Firms are advised to maintain thorough records, cooperate with CPSC staff, and make comprehensive efforts to reach all consumers regarding recalls. The presentation also provides an overview of CPSC's authorities and resources for firms to aid compliance.
SaferProducts.gov is a website launched in 2011 by the U.S. Consumer Product Safety Commission (CPSC) where the public can submit reports of harm relating to consumer products. Reports must contain information in eight required fields and are sent to the identified manufacturer for review before being posted publicly. Over 12,000 incident reports have been published to date, mostly concerning appliances and footwear and injuries have generally been minor. The site allows consumers and companies to search reports, file new reports, and sign up for notifications.
The document discusses how the US Consumer Product Safety Commission (CPSC) reviews consumer product imports at US ports. It provides statistics on the detention rate and most common violations found. It also describes CPSC's pilot risk assessment system, which aims to improve hazard detection at ports and reduce unnecessary detentions and product recalls. The system integrates risk data from shipments, past cases, screening history, injuries, and commercial sources to model enforcement strategy. Expected benefits include saving lives and facilitating legitimate trade while minimizing costs.
The document provides an overview of the U.S. Consumer Product Safety Commission (CPSC). It discusses that the CPSC is an independent federal agency established in 1973 that is responsible for protecting the public from unreasonable risks of injury from consumer products. The CPSC works to reduce an estimated 34,500 deaths and 36 million injuries annually associated with consumer products through regulation and enforcement, recalls, education, and monitoring of voluntary standards. It summarizes the CPSC's laws, regulations, testing and certification requirements, market surveillance, data collection and analysis, and international cooperation to promote product safety.
The document discusses definitions and concepts related to consumer products under the Consumer Product Safety Act (CPSA). It defines a consumer product as any item produced for sale to or use by consumers, with some exceptions like tobacco, vehicles, pesticides. It outlines the CPSA's provisions regarding confidential information disclosure and sharing between agencies. The presentation provides an overview of typical Commission actions and decision-making procedures.
The presentation provides an overview of the U.S. Consumer Product Safety Commission's Office of Compliance and Field Operations. It discusses how the office works to identify product hazards through surveillance activities and in-depth investigations. It outlines the process for mandatory reporting of product defects and describes trends in voluntary recalls and corrective actions. Priorities are identified, including implementation of enforcement programs and review of internal procedures to ensure more timely response. Contact information is provided for those seeking additional guidance.
This document provides an overview and guidance for firms on consumer product recalls and CPSC compliance. It discusses the recall process, from initial reporting of a potential defect to ongoing monitoring and disposal of recalled products. Firms are advised to maintain thorough records, cooperate with CPSC staff, and make comprehensive efforts to reach all consumers regarding recalls. The presentation also provides an overview of CPSC's authorities and resources for firms to aid compliance.
SaferProducts.gov is a website launched in 2011 by the U.S. Consumer Product Safety Commission (CPSC) where the public can submit reports of harm relating to consumer products. Reports must contain information in eight required fields and are sent to the identified manufacturer for review before being posted publicly. Over 12,000 incident reports have been published to date, mostly concerning appliances and footwear and injuries have generally been minor. The site allows consumers and companies to search reports, file new reports, and sign up for notifications.
The document discusses how the US Consumer Product Safety Commission (CPSC) reviews consumer product imports at US ports. It provides statistics on the detention rate and most common violations found. It also describes CPSC's pilot risk assessment system, which aims to improve hazard detection at ports and reduce unnecessary detentions and product recalls. The system integrates risk data from shipments, past cases, screening history, injuries, and commercial sources to model enforcement strategy. Expected benefits include saving lives and facilitating legitimate trade while minimizing costs.
The document provides an overview of the U.S. Consumer Product Safety Commission (CPSC). It discusses that the CPSC is an independent federal agency established in 1973 that is responsible for protecting the public from unreasonable risks of injury from consumer products. The CPSC works to reduce an estimated 34,500 deaths and 36 million injuries annually associated with consumer products through regulation and enforcement, recalls, education, and monitoring of voluntary standards. It summarizes the CPSC's laws, regulations, testing and certification requirements, market surveillance, data collection and analysis, and international cooperation to promote product safety.
The document discusses definitions and concepts related to consumer products under the Consumer Product Safety Act (CPSA). It defines a consumer product as any item produced for sale to or use by consumers, with some exceptions like tobacco, vehicles, pesticides. It outlines the CPSA's provisions regarding confidential information disclosure and sharing between agencies. The presentation provides an overview of typical Commission actions and decision-making procedures.
The presentation provides an overview of the U.S. Consumer Product Safety Commission's Office of Compliance and Field Operations. It discusses how the office works to identify product hazards through surveillance activities and in-depth investigations. It outlines the process for mandatory reporting of product defects and describes trends in voluntary recalls and corrective actions. Priorities are identified, including implementation of enforcement programs and review of internal procedures to ensure more timely response. Contact information is provided for those seeking additional guidance.
This document discusses Section 6(b) of the Consumer Product Safety Act, which governs the U.S. Consumer Product Safety Commission's public disclosure of product-specific information. Section 6(b) requires the CPSC to notify manufacturers and private labelers at least 15 days before disclosure and provide an opportunity to comment. It also establishes exceptions for situations where public health and safety require expedited disclosure. The document reviews the key requirements and exceptions of Section 6(b), as well as related CPSC regulations and the process for judicial review of disclosure decisions.
This presentation provides an overview of toy safety regulations in Canada and the United States. It discusses the key legislation governing consumer product safety in both countries, including the Canada Consumer Product Safety Act and regulations in Canada, as well as the Consumer Product Safety Act and other laws in the US. The presentation also provides highlights of recent changes and initiatives at Health Canada and the CPSC, and outlines requirements for toys in areas such as heavy metals, phthalates, small parts, and sound. Finally, it discusses regulatory cooperation between the two countries through initiatives like joint recalls and information sharing.
The document discusses recalls in the United States, including what prompts recalls by the Consumer Product Safety Commission (CPSC) such as self-reporting of hazards or violations found through investigations. It outlines the CPSC's recall authority in statutes and regulations. A recall involves actions like returning or repairing products and can include corrective action plans between the CPSC and firms. The objectives of recalls are to locate defective products, remove them from the market, and communicate the issue to the public. Recalls are monitored to measure their effectiveness through actions of both recalling firms and the CPSC.
This document discusses coordination between the U.S. Consumer Product Safety Commission (CPSC) and U.S. Customs and Border Protection (CBP) regarding import safety. It outlines how CPSC monitors imports for compliance, triggers for inspections, common violations seen, and opportunities for importers to improve compliance through programs like Importer Self Assessment. The goal is facilitating legitimate trade while expediting the import process and identifying safety issues through data sharing and targeted inspections.
The document discusses a workshop on electronic filing of certificates held by the U.S. Consumer Product Safety Commission (CPSC). It provides an overview of the CPSC's current and proposed rules regarding certificates of compliance for imported consumer products. The CPSC aims to modernize certificate collection by requiring electronic filing of certificates with U.S. Customs and Border Protection at the time of entry. This is intended to streamline the entry process and allow the CPSC to more efficiently review products for safety. The document also outlines the CPSC's risk assessment methodology and collaboration with CBP through data sharing and a pilot risk assessment system.
Electrical products can pose fire, electric shock, burn, and other hazards if they fail or are misused. According to US data from 2006-2008, electrical failures and misuse caused over 50,000 structure fires, 400 deaths, and over $1.3 billion in property losses annually. The CPSC works to promote electrical safety through voluntary standards, technical regulations, bans on unsafe products, surveillance and recalls of defective products, and consumer education. Manufacturers, importers, and consumers all share responsibility for ensuring electrical product safety.
The document summarizes CPSC requirements for adult and children's clothing, including mandatory safety standards and voluntary standards. It discusses four types of safety concerns, strategies to prevent product hazards, and CPSC's role in monitoring voluntary standards and issuing technical regulations if needed to reduce risks. Key requirements outlined are flammability testing, tracking labels, lead and phthalate limits, and restrictions on drawstrings for children's garments. Manufacturers are responsible for ensuring imported products comply with both U.S. regulations and voluntary consensus standards.
Overview of testing, certification, and record keeping requirements for consumer products, including children's products. Addresses initial certification testing, material change testing, and periodic testing if you have continued production. Presentation also addresses optional component part testing. A review of mandatory recordkeeping requirements and undue influence training is also discussed.
The document outlines the Consumer Product Safety Commission's (CPSC) requirements for children's products, including mandatory toy standards, lead and phthalate limits, third-party testing, and certification. It also discusses the CPSC's approach to ensuring safety of non-children's products through voluntary standards, regulations if needed, and general certification requirements. Testing and certification requirements vary depending on if a product is for children or not and what specific safety rules apply.
Phthalate determinations as a means for third party testing cost reduction: questions, issues, and comments. CPSC staff presentation followed by panelist presentations.
An overview of the CPSC PGA message set, electronic filing alpha pilot, and certificate registry with walkthrough of example filing and detailed information on proposed timeline
How to locate CPSC data on regulatory non-compliance notices, which are also called "letters of advice" (LOAs). The referenced Excel table will be updated frequently with the names of the firm, the foreign manufacturer, and other information. Businesses may integrate this information into their compliance workflows to assist them in sourcing safe & compliant consumer products.
An international panel comprised of members of AQSIQ (China), INMETRO (Brazil), Health Canada and CPSC (U.S.) used this presentation to discuss the regulatory structure and suggestions for businesses.
Staff introduction for CPSC workshop on third party testing cost reduction through possible material determinations. Provides workshop agenda, background, and workshop goals
This document discusses the Consumer Product Safety Commission's (CPSC) requirements for furniture, cribs, and children's beds. It provides an overview of the CPSC's mission to protect the public from unreasonable risks of injury from consumer products. It then discusses the CPSC's strategies to prevent product hazards, including supporting improvements to voluntary standards, creating and enforcing technical regulations and bans, identifying and removing hazardous products through recalls, and education programs. Specific requirements are outlined for cribs, toddler beds, bunk beds, and upholstered furniture. Best practices
Liability insurance requirements under the new EU Medical Devices Regulation ...Erik Vollebregt
Presentation at the Q1 conference on 23 May about the new liability regime likely to be imposed under the new new EU Medical Devices Regulation and In Vitro Diagnostics Regulation.
The document discusses 16 CFR Part 1633, the open flame standard for mattresses established by the U.S. Consumer Product Safety Commission (CPSC) effective July 2007. It outlines the test parameters, which include exposing the top and sides of a mattress to an open flame for 70 and 50 seconds respectively then collecting heat release data for 30 minutes. The standard is failed if heat exceeds 200kW at any time or total heat released in the first 10 minutes exceeds 15MJ. The document then describes flame-retardant (FR) barrier fabrics available for use in mattresses, including nonwoven, knit, and laminate options that allow mattresses to pass 1633 requirements.
This document discusses Section 6(b) of the Consumer Product Safety Act, which governs the U.S. Consumer Product Safety Commission's public disclosure of product-specific information. Section 6(b) requires the CPSC to notify manufacturers and private labelers at least 15 days before disclosure and provide an opportunity to comment. It also establishes exceptions for situations where public health and safety require expedited disclosure. The document reviews the key requirements and exceptions of Section 6(b), as well as related CPSC regulations and the process for judicial review of disclosure decisions.
This presentation provides an overview of toy safety regulations in Canada and the United States. It discusses the key legislation governing consumer product safety in both countries, including the Canada Consumer Product Safety Act and regulations in Canada, as well as the Consumer Product Safety Act and other laws in the US. The presentation also provides highlights of recent changes and initiatives at Health Canada and the CPSC, and outlines requirements for toys in areas such as heavy metals, phthalates, small parts, and sound. Finally, it discusses regulatory cooperation between the two countries through initiatives like joint recalls and information sharing.
The document discusses recalls in the United States, including what prompts recalls by the Consumer Product Safety Commission (CPSC) such as self-reporting of hazards or violations found through investigations. It outlines the CPSC's recall authority in statutes and regulations. A recall involves actions like returning or repairing products and can include corrective action plans between the CPSC and firms. The objectives of recalls are to locate defective products, remove them from the market, and communicate the issue to the public. Recalls are monitored to measure their effectiveness through actions of both recalling firms and the CPSC.
This document discusses coordination between the U.S. Consumer Product Safety Commission (CPSC) and U.S. Customs and Border Protection (CBP) regarding import safety. It outlines how CPSC monitors imports for compliance, triggers for inspections, common violations seen, and opportunities for importers to improve compliance through programs like Importer Self Assessment. The goal is facilitating legitimate trade while expediting the import process and identifying safety issues through data sharing and targeted inspections.
The document discusses a workshop on electronic filing of certificates held by the U.S. Consumer Product Safety Commission (CPSC). It provides an overview of the CPSC's current and proposed rules regarding certificates of compliance for imported consumer products. The CPSC aims to modernize certificate collection by requiring electronic filing of certificates with U.S. Customs and Border Protection at the time of entry. This is intended to streamline the entry process and allow the CPSC to more efficiently review products for safety. The document also outlines the CPSC's risk assessment methodology and collaboration with CBP through data sharing and a pilot risk assessment system.
Electrical products can pose fire, electric shock, burn, and other hazards if they fail or are misused. According to US data from 2006-2008, electrical failures and misuse caused over 50,000 structure fires, 400 deaths, and over $1.3 billion in property losses annually. The CPSC works to promote electrical safety through voluntary standards, technical regulations, bans on unsafe products, surveillance and recalls of defective products, and consumer education. Manufacturers, importers, and consumers all share responsibility for ensuring electrical product safety.
The document summarizes CPSC requirements for adult and children's clothing, including mandatory safety standards and voluntary standards. It discusses four types of safety concerns, strategies to prevent product hazards, and CPSC's role in monitoring voluntary standards and issuing technical regulations if needed to reduce risks. Key requirements outlined are flammability testing, tracking labels, lead and phthalate limits, and restrictions on drawstrings for children's garments. Manufacturers are responsible for ensuring imported products comply with both U.S. regulations and voluntary consensus standards.
Overview of testing, certification, and record keeping requirements for consumer products, including children's products. Addresses initial certification testing, material change testing, and periodic testing if you have continued production. Presentation also addresses optional component part testing. A review of mandatory recordkeeping requirements and undue influence training is also discussed.
The document outlines the Consumer Product Safety Commission's (CPSC) requirements for children's products, including mandatory toy standards, lead and phthalate limits, third-party testing, and certification. It also discusses the CPSC's approach to ensuring safety of non-children's products through voluntary standards, regulations if needed, and general certification requirements. Testing and certification requirements vary depending on if a product is for children or not and what specific safety rules apply.
Phthalate determinations as a means for third party testing cost reduction: questions, issues, and comments. CPSC staff presentation followed by panelist presentations.
An overview of the CPSC PGA message set, electronic filing alpha pilot, and certificate registry with walkthrough of example filing and detailed information on proposed timeline
How to locate CPSC data on regulatory non-compliance notices, which are also called "letters of advice" (LOAs). The referenced Excel table will be updated frequently with the names of the firm, the foreign manufacturer, and other information. Businesses may integrate this information into their compliance workflows to assist them in sourcing safe & compliant consumer products.
An international panel comprised of members of AQSIQ (China), INMETRO (Brazil), Health Canada and CPSC (U.S.) used this presentation to discuss the regulatory structure and suggestions for businesses.
Staff introduction for CPSC workshop on third party testing cost reduction through possible material determinations. Provides workshop agenda, background, and workshop goals
This document discusses the Consumer Product Safety Commission's (CPSC) requirements for furniture, cribs, and children's beds. It provides an overview of the CPSC's mission to protect the public from unreasonable risks of injury from consumer products. It then discusses the CPSC's strategies to prevent product hazards, including supporting improvements to voluntary standards, creating and enforcing technical regulations and bans, identifying and removing hazardous products through recalls, and education programs. Specific requirements are outlined for cribs, toddler beds, bunk beds, and upholstered furniture. Best practices
Liability insurance requirements under the new EU Medical Devices Regulation ...Erik Vollebregt
Presentation at the Q1 conference on 23 May about the new liability regime likely to be imposed under the new new EU Medical Devices Regulation and In Vitro Diagnostics Regulation.
The document discusses 16 CFR Part 1633, the open flame standard for mattresses established by the U.S. Consumer Product Safety Commission (CPSC) effective July 2007. It outlines the test parameters, which include exposing the top and sides of a mattress to an open flame for 70 and 50 seconds respectively then collecting heat release data for 30 minutes. The standard is failed if heat exceeds 200kW at any time or total heat released in the first 10 minutes exceeds 15MJ. The document then describes flame-retardant (FR) barrier fabrics available for use in mattresses, including nonwoven, knit, and laminate options that allow mattresses to pass 1633 requirements.
Este documento presenta información sobre los requisitos de seguridad para productos para niños establecidos por la Comisión para la Seguridad de Productos del Consumidor de EE. UU., incluyendo normas voluntarias como ASTM F963 y requisitos legales como los límites de plomo y ftalatos establecidos por la Ley de Mejora de la Seguridad de Productos del Consumidor. También describe los procesos de pruebas de terceros y certificación que los fabricantes deben seguir para cumplir con estas normas y leyes
Jim Helmkamp, Senior Epidemiologist for the National Institute for Occupational Safety and Health Western States Office, presented this at CPSC's ATV Safety Summit Oct. 12, 2012. State-specific ATV fatality rates were compared between 1990-1999 and 2000-2007 grouping states according to helmet, and training and licensure requirements (per SVIA state ATV requirement charts). 2,226 deaths occurred from 1990-1999 at a rate of 0.09 deaths per 100,000 population and 7,231 deaths from 2000-2007 at a rate of 0.32. Male rates were at least six times higher than female rates. Males accounted for about 86% of the deaths overall. Children under 17 years accounted for over one-third of the deaths in the earlier period decreasing to about 17% in the latter. The number of deaths increased 225% from the earlier period to the latter with a three-fold increase in the death rate. There was little collective difference between rates for states with or without helmet requirements and between states with or without training and licensure requirements. Policy-oriented prevention strategies over the past decade seem to have largely failed. This failure may be due to lack of enforcement and the casual attitude of many ATV riders to not wear a helmet or take training.
Este documento presenta los requisitos de seguridad de la Comisión para la seguridad de los productos del consumidor de EE. UU. para la ropa de niños y adultos, incluidos los textiles, la ropa de dormir para niños, los cordones y las mejores prácticas de fabricación. Se describen las normas voluntarias y los reglamentos técnicos, así como las responsabilidades
This presentation provides information from the U.S. Consumer Product Safety Commission about all-terrain vehicle (ATV) safety. It discusses the CPSC's role in protecting consumers from unsafe products, and why ATV safety is important. The presentation covers topics like where ATVs can be legally ridden, requirements for riders and passengers, ensuring all operators are properly trained, and tips for buying an ATV. Resources on ATV safety statistics, public service announcements, and publications are also provided. The overall goal is to educate about ATV safety and encourage sharing safety information with others.
This document provides an overview of US regulations for clothing sold in the US market. It discusses key textile regulations including the Flammable Fabrics Act (FFA) and standards such as 16 CFR Part 1610 for flame resistance and 16 CFR Parts 1615/1616 for sleepwear. It also covers the Consumer Product Safety Improvement Act (CPSIA) and requirements for lead, phthalates, and testing. Contact information is provided for the expert on US clothing compliance regulations.
Dr. Charles Jennissen, of the University of Iowa Department of Emergency Medicine presented this at CPSC's ATV Safety Summit Oct. 12, 2012. The study objective was to determine the ATV anticipatory guidance practices of primary care providers, as well as their attitudes, knowledge, and the barriers faced in educating families about the risk of ATV use. Methods: An electronic survey was administered to primary care providers belonging to Iowa state medical societies. Results: More than 60% of respondents (N=218) believed that providing ATV anticipatory guidance was important. However, 78% gave ATV safety counseling less than 10% of the time during regular pediatric exams, and only 12% did so greater than 25% of the time. Families rarely ask providers for advice on ATV safety issues; 84% of providers were asked once a year or less. ATV knowledge scores were low (median score 2 of 12); however, those with previous ATV exposure had significantly higher scores. Many respondents affirmed insufficient knowledge (47%) and inadequate resources (63%), but the most commonly identified barrier was that it was not a routine part of their practice.
Cam Arnold, Vice-President of the Right Rider Access Fund, presented this at CPSC’s ATV Safety Summit Oct. 11, 2012. The Right Rider Access Fund sponsored "Do the Ride Thing", an ATV and dirt bike safety video contest, in collaboration with the ATV Safety Institute and the Motorcycle Safety Foundation. "Do the Ride Thing" enhances young riders' knowledge of the "Golden Rules" of ATV safety while empowering them to communicate safety messages to their peers through their own PSA video. The contest, in its third year, ran from June 1 to August 15, 2012 and offered 19 prizes totaling $8,500. Students ages six to 18 could enter. Creating a safety video that highlights one or more of ASI's "Golden Rules" is a great way to motivate and inform the public - especially kids and their parents - about the safe and responsible use of all-terrain vehicles. The contest harnesses the social networking power of YouTube and it gives kids the opportunity to "Do the Ride Thing" and help other kids ride safe/ride smart.
This presentation on fire reduction strategies for residential furniture details the role of flame retardants and compares usage and analysis in various jurisdictions.
Determinations for lead and the eight elements in ASTM F963 as a means for third party testing cost reduction: questions, issues, and comments. CPSC staff presentation followed by panelist presentations
The US Consumer Product Safety Commission held a workshop on April 3, 2014 to discuss potential ways to reduce the costs of third party testing for product safety compliance while still ensuring safety. The workshop included a panel of representatives from consumer advocacy groups and industry associations and allowed for public comments. Attendees were reminded that the views expressed were those of participants and not official government policies.
The document provides an overview of the CPSC eFiling Alpha Pilot, which will test electronic filing of product safety data through a small group of volunteers. The pilot aims to streamline import processes, identify high-risk cargo, and generate reports to help the agency with risk assessment and priority setting. Key details covered include what data will be collected on regulated products and specific products on the Substantial Product Hazard list.
The National Electronic Injury Surveillance System (NEISS) collects data on consumer product-related injuries from a sample of 96 US hospitals. It provides annual injury estimates and information on products involved, patient demographics, and narrative details. NEISS has operated for over 30 years to support the US Consumer Product Safety Commission (CPSC) and other agencies in identifying hazardous products and injury trends. The system collects around 400,000 injury reports annually.
There are an estimated 33.3 million people living with HIV (the virus which causes AIDS) worldwide and approximately 2.6 million people are newly-infected each year. While the Asian and African regions account for more than 90% of the HIV-infected population (with the highest number in Sub-Saharan Africa), the U.S. and European regions make up greater than 60% of the HIV testing market. This TriMark Publications report provides a comprehensive examination of the HIV/AIDS testing market, a specific segment of the in vitro diagnostics (IVD) market as it relates to infectious diseases. It examines the available and emerging technologies being utilized by the HIV testing field, defines the dollar volume of sales'both in the U.S. and worldwide'and analyzes the factors that influence the size and growth of the market. The chief HIV testing assays, i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic, are covered thoroughly, as are high-growth applications in different clinical diagnostic areas and expanding markets, such as employee screening, emergency medicine and satellite clinic testing. Additionally, this analysis covers the following areas in details: enzyme-linked immunosorbent assay (ELISA), antibody/p24 antigen test (fourth-generation test), Western blot assay, line immunoassays, indirect fluorescent antibody (IFA) assay, nucleic acid tests for infectious diseases, and the emerging technologies related to HIV and AIDS diagnosis. Moreover, this study also provides a thorough analysis of the companies known to be marketing, manufacturing or developing HIV testing products, as well as provides detailed tables and figures covering HIV testing markets around the globe.
Signal detection and their assessment in clinical trialsClinosolIndia
Signal detection in clinical trials is a crucial aspect of pharmacovigilance that involves identifying potential safety concerns or signals associated with the use of investigational drugs. The process of signal detection is ongoing throughout the life cycle of a drug, from early-phase trials to post-marketing surveillance. Here's an overview of signal detection and the assessment process in clinical trials
The document discusses the risks of IoT devices and the need for improved security practices. It notes that many applications contain inherited vulnerabilities from reused components and fail to meet basic security standards. The document outlines UL's new 2900 security certification for network-connected products which evaluates vendors' risk management processes and requires documentation of a product's design, use, vulnerabilities, and security controls.
FDA has made several efforts to secure the pharmaceutical supply chain:
1. The Office of Compliance within CDER was reorganized to better address threats like counterfeiting, diversion, and intentional adulteration. A new Office of Drug Security, Integrity, and Recalls was created.
2. Preliminary analysis of FDA criminal case information from 2003-2008 found that the top five branded drugs targeted were Zyprexa, Viagra, Lipitor, Zoloft, and Risperdal, and that solid oral dosage forms were most at risk.
3. FDA is working on track and trace standards and held a public workshop on the topic in 2011. A track and trace system
Fda postmarket surveillance-report-september-remediatedgarridosk
This document proposes strengthening the US national system for medical device postmarket surveillance. It outlines 4 key actions: 1) Establish a unique device identification system. 2) Promote national/international device registries. 3) Modernize adverse event reporting and analysis. 4) Develop new methods for evidence generation, synthesis, and appraisal. The goal is a near real-time surveillance system using electronic health data to quickly identify safety issues and characterize device risks and benefits.
Micro Focus GPAS is an innovative and comprehensive cloud-based Brand Protection, Track & Trace and Consumer Engagement Service that drives business value by addressing problems and challenges that organizations face when operating within global markets.
Since its creation in 2009, GPAS has be-come the global standard to solving counterfeit, grey market and supply chain challenges surrounding the manufacture and distribution of finished goods. GPAS protects some of the world’s largest and innovative brands across a variety of market sectors including Food & Beverage, FMCG, Pharmaceutical, Nutraceutical, Apparel and Electronics to name a few.
Global Molecular Diagnostics Market: Innovative Technologies and Emerging Bus...ReportLinker.com
This unique seven-country report contains 1,050 pages, 96 tables, and is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during this decade. The report explores business and technological trends in the US, five major European countries, (France, Germany, Italy, Spain, UK) and Japan; provides 5- and 10-year test volume/sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next ten years.The molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next ten years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods. In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new DNA probe and biochip technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next ten years.
Implementing Agile in an FDA Regulated EnvironmentTechWell
Developing medical devices that are subject to FDA approval has traditionally followed the waterfall methodology, largely due to the structure of the regulations that govern development practices. But we know from myriad case studies in different industries that agile methodologies are far superior in providing the highest value to customers in the shortest time to market. Neal Herman shares how one developer of complex medical devices embraced agile software development practices and proved that it could not only develop software faster with higher quality but also meet all regulatory requirements. Convincing the internal quality management, systems engineering, and regulatory departments was difficult, but the software department was able to overcome these obstacles and fundamentally change the company’s philosophy on product development. Since 2012, software development productivity is up 100 percent, and quality is up 200 percent. Now, after seeing these gains from the software department, agile is being rolled out to all areas of R&D including hardware.
There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade. The emphasis in this TriMark Publications report is on those companies that are actively developing and marketing high-growth diagnostic testing technologies in the clinical hospital market. It defines the dollar volume of sales, both worldwide and in the U.S., of the market and analyzes the factors that influence the size and growth of market segments. The study goes on to discuss in detail trends that have developed which have stimulated this market, and also comments in detail patterns of information processing in the high-growth diagnostic testing technologies. Moreover, this exanimation provides an overview of the diagnostic testing market, including the latest information regarding exciting new products and industry trends. It will not only quantify but also qualify the market high-growth segments as an area of research and investment. Forecasts of the market and analyses of products in the worldwide prescriptions market will provide a basis for understanding the significance of past developments and future possibilities within this therapeutic category.
Computer Software Assurance (CSA): Understanding the FDA’s New Draft GuidanceGreenlight Guru
Understand the FDA's new draft guidance on Computer Software Assurance (CSA).
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Competing in the European Molecular Diagnostics Market: France, Germany, Ital...ReportLinker.com
This new 970-page comprehensive five-country report from Venture Planning Group is designed to help current suppliers and potential market entrants identify and evaluate the major business opportunities emerging in the European molecular diagnostics market during the next five years. The report explores business and technological trends in major European countries (France, Germany, Italy, Spain, UK); provides 5-year test volume/sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next five years.The $4.5 billion molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next five years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of and cost-effective automated systems with amplification methods. In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next five years.
Future Horizons in the European Molecular Diagnostics Market--France, Germany...ReportLinker.com
This comprehensive five-country report is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during the next five years. The report explores business and technological trends in major European countries (France, Germany, Italy, Spain, UK); provides 5-year test volume/sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next five years.The $4.5 billion molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next five years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods. In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next five years. Contains 970 pages and 75 tables
Regulatory oversight of genetic testing in Canada: Health Canada perspectiveMaRS Discovery District
Speaker: Patrice Sarrazin, PhD, Senior Scientific Evaluator, In Vitro Diagnostic Devices, Medical Devices Bureau, Therapeutic Product Directorate, Health Canada. Patrice discusses Health Canada's perspective on genetic testing as well as policy and regulation in Canada.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
Major developments in point-of-care (POC) testing were highlighted at the 2015 American Association of Clinical Chemistry Annual Meeting:
1) Several companies announced new POC devices, including a low-cost, battery-powered molecular diagnostics platform from Cepheid and a smartphone-based chlamydia test.
2) Existing POC tests for influenza, diabetes, kidney disease, liver disease, and pregnancy from companies like Alere, DiaSys Diagnostics, and Abbott were demonstrated.
3) The large POC diagnostics market, estimated at $17 billion globally, was a focus for many exhibitors given the potential for rapid results at the point of care.
Presenting- Signal mining in PharmacovigilanceClinosolIndia
Signal mining in pharmacovigilance involves the systematic analysis of large datasets to identify potential safety signals associated with medications. It encompasses a variety of computational and statistical methods aimed at detecting patterns or trends that may indicate previously unrecognized adverse drug reactions (ADRs). Signal mining relies on data from sources such as spontaneous reporting systems, electronic health records, clinical trials, and medical literature. Advanced algorithms and data mining techniques, including disproportionality analysis, Bayesian data mining, and machine learning, are employed to sift through vast amounts of data to uncover potential signals of concern. These signals are then subjected to further evaluation to determine their clinical relevance and potential impact on patient safety. By leveraging the power of big data and analytics, signal mining plays a crucial role in enhancing pharmacovigilance efforts, enabling proactive identification and mitigation of medication-related risks, and ultimately contributing to improved patient care and drug safety.
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The document discusses regulation and quality control of health apps. It begins with an overview of the digital health landscape and how different types of apps may be regulated to varying degrees. It then discusses challenges in managing chronic diseases and how data from apps and devices could potentially help transform care if delivered in an actionable way. The rest of the document discusses regulatory frameworks for medical software and apps, standards that may apply, and issues to consider like safety, security, usability and how to demonstrate safety for apps and systems that include software.
Health apps regulation and quality control case studies and session 2 present...3GDR
The document discusses regulation and quality control of health apps. It begins with an overview of the digital health landscape and how different types of apps may be regulated to varying degrees. It then discusses challenges in managing chronic diseases and how data from apps and devices could potentially help patients if transformed and delivered in an actionable way. The rest of the document discusses regulatory frameworks for medical software and apps, standards that may apply, and issues to consider like safety, security, usability and more. It also provides examples of how safety cases are used in other industries like nuclear to help build confidence in critical systems.
Innovative Molecular Diagnostic Technologies and Emerging MarketsReportLinker.com
This unique seven-country report contains 1,050 pages, 96 tables, and is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during this decade. The report explores business and technological trends in the US, five major European countries, (France, Germany, Italy, Spain, UK) and Japan; provides 5- and 10-year test volume/sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next ten years.The molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next ten years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods. In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new DNA probe and biochip technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next ten years.
A briefing for the Consumer Product Safety Commission by CPSC staff from the Directorate for Engineering Sciences, Division of Mechanical Combustion Engineering.
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The document describes Best Buy's product safety compliance program. It outlines the governance structure, which includes oversight from the Board of Directors down to operational teams. It details the product incident management process, including review of incidents and recalls. Best Buy has integrated systems to quickly block the sale and distribution of recalled products. It works with third-party partners and provides guidance on new product categories. Continuous improvement is emphasized through monitoring, training, and review of trends.
Este documento lista los diferentes sectores interesados en la seguridad de los productos de consumo y describe la información y perspectivas que cada uno puede aportar. Los sectores incluyen fabricantes, importadores, comercializadores, instituciones académicas, consumidores, organismos de normalización y certificación, y agencias gubernamentales. Cada sector puede proporcionar datos sobre accidentes, quejas de consumidores, pruebas de productos y cumplimiento de normas. La colaboración entre estos grupos es importante para garantizar la protección de
Regulatory cooperation should be relevant and responsive to real world challenges. This panel provides perspectives on new trends, products, and hazards and what can be done within the North America Cooperation framework. Points of focus: Cooperation and best practices, Policy Alignment, Consumer messaging.
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The document summarizes discussions from a panel on high energy lithium-ion batteries. It covers three main topics:
1. Charles Monahan of Panasonic discussed lithium-ion battery design and manufacturing, including cell components and thermal runaway risks.
2. Don Mays of Samsung presented on the Galaxy Note 7 recall, including an 8-point battery safety test and analyzing reported incidents.
3. Rick Brenner discussed challenges importers face in sourcing safe lithium-ion products, such as unlicensed generics and misleading compliance claims. He suggested stricter standards that mandate battery management system certification.
Hazards associated with high energy density batteries are common to all three jurisdictions. How can risk to consumers be reduced and what steps have already been taken by stakeholders in North America? Points of focus: 1. Industry's product safety processes pre- and post-market. 2. Understanding and eliminating failure modes. Challenges and how can stakeholders and regulators work together to improve safety?
Presenters: Charlie Monahan, Director, Regulatory Compliance, Panasonic; Don Mays, Chief Safety and Quality Officer, Samsung; Rick Brenner, President, Product Safety Advisors, LLC.
Este documento resume el panorama del comercio electrónico en México. Algunos puntos clave son: 1) México ocupa el puesto 17 a nivel mundial en atractivo para el desarrollo del comercio electrónico. 2) Actualmente hay 97.2 millones de suscripciones de servicios de Internet en México. 3) 3 de cada 4 usuarios de Internet en México realizaron una compra en línea en 2017. 4) El monto de las operaciones de comercio electrónico en México en 2016 fue de 17.63 billones de dólares
Stakeholders and regulators discuss the benefits and challenges posed by the rapid expansion of e-commerce. Discussion of industry processes and best practices. How can regulators help platforms help their sellers and consumers?
Presenters: Doug Hyland, Compliance Program Manager, zulily; Stuart Schmidt, Manager, Trade Compliance, UPS; Carlos Ponce Beltran, Deputy Attorney for Telecommunications, PROFECO.
The document discusses North American cooperation between the US Consumer Product Safety Commission, Health Canada, and Mexico's PROFECO on consumer product safety issues. It provides examples of joint projects between the agencies, including social media campaigns on various safety topics, presentations at industry events, webinars on safety requirements, and customs cooperation initiatives like joint exercises and information sharing. Inter-laboratory cooperation is also summarized, such as exercises comparing testing of lead, phthalates, and X-ray fluorescence technology, as well as staff exchanges and training. A total of 24 simultaneous/joint recalls across North America are mentioned since 2013 involving products like glass tumblers, TV stands, bicycles, speakers, wall adapters, ATVs,
The CPSC works closely with CBP to screen imported consumer products for safety violations. CPSC staff are located at major ports to work directly with CBP during the import process. Using a Risk Assessment Methodology and trade data from CBP, CPSC targets high-risk shipments for examination. CPSC and CBP conduct joint audits of importers to provide guidance on regulations and requirements. Through coordination and data sharing, CPSC aims to intercept violative products and protect consumers.
The document discusses what happens when a shipment is held for examination at a U.S. port of entry. Cargo may be targeted by the Consumer Product Safety Commission (CPSC) or other agencies. The CPSC works with Customs and Border Protection (CBP) at ports. If cargo is held, the responsible agency examines it at a Centralized Examination Site. Examinations can result in full release, sampling and conditional release, or sampling and detention of goods.
The one-day Recall Effectiveness Workshop agenda includes presentations on the recall process, recall data, and communicating hazards. It also has open discussion sessions on what defines an effective recall and how to best utilize social media, in-store notifications, and other forms of communication. Break-out groups will discuss consumer motivation and technological advances to improve recall effectiveness.
Presentation by Blake G. Rose, Director, Defect Investigations Division Office of Compliance and Field Operations on CPSC Review of Recall Process and Standard Notifications.
Presentation Date: July 25, 2017
The document provides information about registering a business account on the CPSC Business Portal. It outlines the multi-step registration process, important concepts like roles and responsibilities, how to make changes to an account, small batch manufacturer certification, and potential problem areas. It also includes examples of the various emails sent during the registration and activation process.
This document summarizes the requirements for manufacturers and importers to certify that their products requiring special packaging comply with the Poison Prevention Packaging Act (PPPA). A General Certificate of Conformity must be filed certifying the special packaging meets the performance specifications outlined in 16 C.F.R. § 1700.15. Manufacturers and importers must maintain records of tests or reasonable testing programs to support their certifications. The document provides guidance on the requirements for PPPA certifications.
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1. U.S. Consumer Product Safety
Commission
Market Surveillance
Dennis Blasius, Director,
Field Investigations
This presentation was prepared by CPSC staff, has not been reviewed or approved
by, and may not reflect the views of, the Commission. 1
2. How CPSC Prevents Injuries and Deaths
Identifies,
Voluntary
Regulations monitors,
Standards
analyzes trends
Conducts risk Educates on
Conducts
assessments manufacturing
research
for safety
Surveillance: Investigations,
Educates on safe
retail, Internet, Recalls,
use
ports Compliance
3
3. Strategic Goal –
Rigorous Hazard Identification
Objectives:
1. Improve the quality and comprehensiveness of crucial product
hazard data.
2. Reduce the time it takes to identify hazard trends by improving
the collection and assessment of hazard data.
3. Establish a transparent, risk-based methodology to identify
consistently and prioritize hazards to be addressed.
4. Expand import surveillance efforts to reduce entry of unsafe
products at U.S. ports.
5. Scan the marketplace regularly to determine whether previously
identified significant hazards exist in similar products.
6. Increase surveillance of used and resale consumer products to
identify and remove recalled products and substantial product
hazards.
3
4. Surveillance Databases
IPII DTHS INDP NEISS
Injury and National
potential Electronic
Death In-Depth
injury Injury
certificates Investigations
incident Surveillance
data* System
4
5. IPII
IPII Data Sources
Medical
Examiner
Federal
and
News Hotline Internet Compliance and State Other
Coroner
Clips Calls Reports Reports Agency Reports
Alert
Referrals
Program
(MECAP)
5
6. Market Surveillance Activities
• Program plan for regulated
products; surveillance for defects
Retail and other risks
• Check for conformity with
regulations and for recalled
Internet products
• Investigators at key ports of entry
Ports and • Analysts identify most likely at-
Airports risk products
6
7. Responsibility to Comply with Voluntary
Standards and Technical Regulations
All equally responsible
Manufacturers
Distributors Retailers
Importers
7
8. Market Place Surveillance
FY13 Number of Consumer Products Screened *
Internet
Retail
Import 7,960 - 6%
10,020 - 9%
9,100 - 9%
Resale
*as of 2/21/13
80,285 - 75% 8
Focused on identifying hazards – includes new publicly available databaseSpeed – reduce time to make initial determinationPrioritize threats – transparent and open4, 5, and 6) Inspection and surveillance in traditional and non-tradition markets.
Visit importer and wholesaler chat rooms, group list-serves, and Internet auction sites to develop leads regarding retailers and wholesalers who might be offering obvious violative, recalled, or dangerous products.CPSC co-located at busiest ports working with U.S. Customs and Border Protection inspectors, allowing for close and careful scrutiny of the import documentation filed by the import broker for anomalies and physical screening of products by CPSC Field Investigators at the portVarious agencies co-locate analyst staff at the Commercial Targeting Analysis Center (CTAC) in downtown Washington, DC, which leverages targeting ability – identifying most likely at-risk products