Jessica Franken, INDA Director of Government Affairs & Dawnee Giammittorio, INDA Associate Director of Government Affairs11.06.13
INDA members that make medical devices should take note that the Food and Drug Administration (FDA) released a final rule on Sept. 24 requiring most medical devices distributed in the U.S. to carry a unique device identifier (UDI). A UDI is a numeric or alphanumeric code that includes a model type, serial number, batch number, and manufacturing and expiration dates.
Congress directed the FDA in the FDA Amendments Act of 2007 to develop a UDI system for medical devices to provide for more effective tracking and recall of problem products. The FDA worked closely with industry, the clinical community, and patient and consumer groups, and conducted four pilot studies in developing the UDI system. The final rule has two components: establishing the UDI labeling requirements for devices and creating a searchable public database.
The rule phases in the UDI system over several years, focusing first on devices posing the greatest potential harm to patients while exempting many low-risk devices from some or all of the requirements. The rule requires high-risk medical devices (Class III) such as pacemakers, defibrillators, heart pumps and artificial joints, to carry UDIs on their labels and packaging within one year of implementation. Class II (moderate risk) devices, which include nonwoven tampons, surgical drapes, gowns, and masks, will be required to comply with the new labeling requirements within three years, and manufacturers of nonexempt Class I devices will be given five years to mark their devices. Many over-the-counter devices sold at retail will be exempt from the rule. Industry applauded a change from an earlier proposal that allows manufacturers a three-year exemption for products currently held in inventory.
The rule also establishes a publicly searchable database called the Global Unique Device Identification Database (GUDID). The database will serve as a reference catalog for every device with an identifier, but will not include any patient data.
The FDA estimates compliance with the rule will cost manufacturers $86 million a year. Companies will need to integrate the UDI into existing information systems, redesign device labels to incorporate a barcode, test barcode printing software, install equipment needed to print and verify the UDI on labels, and train employees.
To read the Federal Register notice for the rule, go to:
www.gpo.gov/fdsys/pkg/FR-2013-09-24/html/2013-23059.htm
For a draft guidance on the GUDID, go to:
www.gpo.gov/fdsys/pkg/FR-2013-09-24/html/2013-23058.htm
International chemical regulatory reform measures move forward
Efforts to reform The Toxic Substances Control Act of 1976 (TSCA) have stalled repeatedly in the U.S. Congress even though most stakeholders agree the law is outdated and ineffective. Meanwhile other countries, including trade destinations important to INDA members, have been advancing chemical safety reform measures. Companies that manufacture in or import chemicals to South Korea, Taiwan, and India should take note that reform of chemical laws in those countries is in varying stages of development and implementation.
South Korea. South Korea is the furthest along in the process of chemical reform. In April, Korea revamped its Toxic Chemical Control Act (TCCA), in effect since 1991, by dividing the law into The Act on the Registration and Evaluation of Chemicals (K-REACH) and the Chemicals Control Act (CCA). The new regulatory scheme takes effect Jan. 1, 2015 with K-REACH governing the registration and evaluation of chemicals and CCA focusing on the control of hazardous substance and response to chemical accidents.
K-REACH aims to protect public health and the environment through a comprehensive four-pronged approach: the registration of chemicals, the screening of hazardous chemicals, the assessment of products containing chemicals and hazardous substances, and sharing information on chemicals. Under the chemical registration requirement, manufacturers and importers must file data sets on existing chemicals at the threshold volume of 1000 kg/year; on all new chemicals at any volume before actually being manufactured or imported; and at specified volumes for known hazardous chemicals. Products containing greater than 0.1% of a hazardous chemical must be registered unless the substance is contained in a solid form that is not released under normal use. In order to share data, companies must join a consortium for each chemical required to be registered. The Ministry of Environment is responsible for the registration and evaluation of chemical substances and has a range of remedies available to it, including requiring product safety labeling, ordering recalls, requiring prior authorization for use, or banning sales entirely.
Taiwan. Taiwan is currently in the process of modifying its regulation of toxic chemicals by enacting a law to govern new chemicals and amending an existing law to provide for registration of a greater number of existing chemicals. The Occupational Safety and Health Act (OSHA), adopted July 3, bans the manufacture, import or use of any new substance without prior notification. Industry is invited to nominate chemicals to the inventory of existing chemicals list online at:
http://csnn.cla.gov.tw/conten /Substance_Query_Q.aspx.
Meanwhile, amendments to Taiwan’s Toxic Chemical Substance Control Act (TCSCA) are currently making their way through the legislative process and are expected to be adopted next year. The amendments will tighten the management of toxic substances of Class 4 (defined as chemical substances for which there is concern of pollution of the environment or the endangerment of human health) and will require manufacturers and importers to register designated priority chemicals before placing them on the market.
While OSHA will not take effect until one year after the completion of the TCSCA amendments, Taiwanese officials nonetheless are advising companies to prepare now for the changes by taking note of the substances and their volumes currently being exported to Taiwan, checking the existing national chemicals inventory, and monitoring the final stages of the passage of the TCSCA amendments.
India. India is in the early stages of formulating its national chemical policy, working to consolidate multiple laws into one coherent and comprehensive piece of legislation that will simplify implementation and monitoring. Policymakers are leaning towards adopting a registration approach like that used by the European Union and South Korea under EU-REACH and K-REACH rather than an inventory approach like currently employed by U.S. under TSCA. However, a government official from the Ministry of Chemicals and Fertilizers said in October that the legislation will most likely be simpler than EU-REACH. The official also said a final policy draft is expected early in 2014. Chemexcil, the chemicals export council in India, is also working to compile the first national chemicals inventory, which currently contains some 5,000 chemicals.
United States. Meanwhile, a bill to overhaul TSCA which seemed promising in May when first introduced by the late Senator Frank Lautenberg (D-N.J.) and Sen. David Vitter (R-La.) still lingers in the current Congress. The Chemical Safety Improvement Act of 2013 (S. 1009) enjoys bipartisan support in the Senate and represents a surprisingly centrist approach, with both industry and environmental interests compromising on certain key elements in the measure.
However, while most observers agree that a TSCA overhaul is long overdue, it remains to be seen whether sweeping legislation to do so will gain any traction in the current political climate, particularly with strong opposition to expanding regulation by the Environmental Protection Agency in the Republican-controlled House. With wounds still raw from the all too recent government shutdown and debt-ceiling debates, and the clock ticking for another round to begin, one wonders whether this Congress will move any other major legislation this year.
Congress directed the FDA in the FDA Amendments Act of 2007 to develop a UDI system for medical devices to provide for more effective tracking and recall of problem products. The FDA worked closely with industry, the clinical community, and patient and consumer groups, and conducted four pilot studies in developing the UDI system. The final rule has two components: establishing the UDI labeling requirements for devices and creating a searchable public database.
The rule phases in the UDI system over several years, focusing first on devices posing the greatest potential harm to patients while exempting many low-risk devices from some or all of the requirements. The rule requires high-risk medical devices (Class III) such as pacemakers, defibrillators, heart pumps and artificial joints, to carry UDIs on their labels and packaging within one year of implementation. Class II (moderate risk) devices, which include nonwoven tampons, surgical drapes, gowns, and masks, will be required to comply with the new labeling requirements within three years, and manufacturers of nonexempt Class I devices will be given five years to mark their devices. Many over-the-counter devices sold at retail will be exempt from the rule. Industry applauded a change from an earlier proposal that allows manufacturers a three-year exemption for products currently held in inventory.
The rule also establishes a publicly searchable database called the Global Unique Device Identification Database (GUDID). The database will serve as a reference catalog for every device with an identifier, but will not include any patient data.
The FDA estimates compliance with the rule will cost manufacturers $86 million a year. Companies will need to integrate the UDI into existing information systems, redesign device labels to incorporate a barcode, test barcode printing software, install equipment needed to print and verify the UDI on labels, and train employees.
To read the Federal Register notice for the rule, go to:
www.gpo.gov/fdsys/pkg/FR-2013-09-24/html/2013-23059.htm
For a draft guidance on the GUDID, go to:
www.gpo.gov/fdsys/pkg/FR-2013-09-24/html/2013-23058.htm
International chemical regulatory reform measures move forward
Efforts to reform The Toxic Substances Control Act of 1976 (TSCA) have stalled repeatedly in the U.S. Congress even though most stakeholders agree the law is outdated and ineffective. Meanwhile other countries, including trade destinations important to INDA members, have been advancing chemical safety reform measures. Companies that manufacture in or import chemicals to South Korea, Taiwan, and India should take note that reform of chemical laws in those countries is in varying stages of development and implementation.
South Korea. South Korea is the furthest along in the process of chemical reform. In April, Korea revamped its Toxic Chemical Control Act (TCCA), in effect since 1991, by dividing the law into The Act on the Registration and Evaluation of Chemicals (K-REACH) and the Chemicals Control Act (CCA). The new regulatory scheme takes effect Jan. 1, 2015 with K-REACH governing the registration and evaluation of chemicals and CCA focusing on the control of hazardous substance and response to chemical accidents.
K-REACH aims to protect public health and the environment through a comprehensive four-pronged approach: the registration of chemicals, the screening of hazardous chemicals, the assessment of products containing chemicals and hazardous substances, and sharing information on chemicals. Under the chemical registration requirement, manufacturers and importers must file data sets on existing chemicals at the threshold volume of 1000 kg/year; on all new chemicals at any volume before actually being manufactured or imported; and at specified volumes for known hazardous chemicals. Products containing greater than 0.1% of a hazardous chemical must be registered unless the substance is contained in a solid form that is not released under normal use. In order to share data, companies must join a consortium for each chemical required to be registered. The Ministry of Environment is responsible for the registration and evaluation of chemical substances and has a range of remedies available to it, including requiring product safety labeling, ordering recalls, requiring prior authorization for use, or banning sales entirely.
Taiwan. Taiwan is currently in the process of modifying its regulation of toxic chemicals by enacting a law to govern new chemicals and amending an existing law to provide for registration of a greater number of existing chemicals. The Occupational Safety and Health Act (OSHA), adopted July 3, bans the manufacture, import or use of any new substance without prior notification. Industry is invited to nominate chemicals to the inventory of existing chemicals list online at:
http://csnn.cla.gov.tw/conten /Substance_Query_Q.aspx.
Meanwhile, amendments to Taiwan’s Toxic Chemical Substance Control Act (TCSCA) are currently making their way through the legislative process and are expected to be adopted next year. The amendments will tighten the management of toxic substances of Class 4 (defined as chemical substances for which there is concern of pollution of the environment or the endangerment of human health) and will require manufacturers and importers to register designated priority chemicals before placing them on the market.
While OSHA will not take effect until one year after the completion of the TCSCA amendments, Taiwanese officials nonetheless are advising companies to prepare now for the changes by taking note of the substances and their volumes currently being exported to Taiwan, checking the existing national chemicals inventory, and monitoring the final stages of the passage of the TCSCA amendments.
India. India is in the early stages of formulating its national chemical policy, working to consolidate multiple laws into one coherent and comprehensive piece of legislation that will simplify implementation and monitoring. Policymakers are leaning towards adopting a registration approach like that used by the European Union and South Korea under EU-REACH and K-REACH rather than an inventory approach like currently employed by U.S. under TSCA. However, a government official from the Ministry of Chemicals and Fertilizers said in October that the legislation will most likely be simpler than EU-REACH. The official also said a final policy draft is expected early in 2014. Chemexcil, the chemicals export council in India, is also working to compile the first national chemicals inventory, which currently contains some 5,000 chemicals.
United States. Meanwhile, a bill to overhaul TSCA which seemed promising in May when first introduced by the late Senator Frank Lautenberg (D-N.J.) and Sen. David Vitter (R-La.) still lingers in the current Congress. The Chemical Safety Improvement Act of 2013 (S. 1009) enjoys bipartisan support in the Senate and represents a surprisingly centrist approach, with both industry and environmental interests compromising on certain key elements in the measure.
However, while most observers agree that a TSCA overhaul is long overdue, it remains to be seen whether sweeping legislation to do so will gain any traction in the current political climate, particularly with strong opposition to expanding regulation by the Environmental Protection Agency in the Republican-controlled House. With wounds still raw from the all too recent government shutdown and debt-ceiling debates, and the clock ticking for another round to begin, one wonders whether this Congress will move any other major legislation this year.
