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As the blossoms emerge and a renewed sense of optimism fills the air, we are excited to have you join us on this journey of unraveling the intricacies of navigating product access in the United States. Whether you're a seasoned professional or just starting your career, we hope to provide valuable insights to help you successfully navigate the intricate landscape of product compliance. Thank you for joining us on this informative journey!

Product access. Two words, infinite implications. It's a concept that can make or break a business, a product, or a dream. The U.S. has a complex landscape comprising product performance and safety standards, building and safety codes, governmental regulations, voluntary programs and governmental legislation. But fear not. This maze isn't unconquerable. We delve into this labyrinth, examining its many twists and turns so you can successfully navigate product access in the U.S. Not understanding this labyrinth can be costly, both in time and resources. Ignorance is not bliss nor an available legal defense in the U.S. legal system. Getting help from knowledgeable third parties, such as consultants, will help you learn and navigate the U.S. market access.

Product access in the U.S.

Product access is the doorway to the marketplace. It has to be fought for and earned. The battlefield is strewn with product performance and safety standards, building and safety codes, governmental regulations, voluntary programs and legislation. These are the weapons and the armor. The tools that are used to secure market access.

Product access in the U.S. is a journey punctuated by a myriad of bureaucratic hoops to jump through from gatekeepers, such as regulatory bodies, standards development organizations, code development organizations, third-party certification agencies and testing laboratories, to name a few. Every business will interact with these gatekeepers along the way. In addition to the gatekeepers, there are third parties, such as consultants. These consultants can help you work with the gatekeepers to open up the lucrative US market.

Understanding standards in the U.S. framework

Voluntary consensus standards are the defining traits of a product, outlining its quality, safety and performance parameters developed by industry stakeholders. Standards set a bar determining what is acceptable, deemed safe, and allowed into the marketplace. The standards game is a tough one. They are constantly evolving, morphing, and growing. Keeping up with them is essential yet challenging. Knowledge is power. So, arm yourself with understanding. Or not. It's a crucial game of hit-and-miss.

Product access and U.S. regulations

Regulations are a roadmap. They show the way, guiding you toward product access. But, like any map, they need to be read correctly. Misinterpretation can lead to detours, delays, and dead ends. Compliance is key. It's your ticket to the market and the passport for your product. Regulations change. They have to. They adapt to changing market conditions, technological advancements, and societal needs. Keeping up with them yourself or through a consultancy is essential for maintaining product access.

The connection between U.S. regulations and standards

US agencies are directed to "use standards developed or adopted by voluntary consensus standards bodies rather than government-unique standards, except where inconsistent with applicable law or otherwise impractical." Standards development organizations (SDOs) are instrumental in shaping regulations and standards. However, U.S. SDOs are rarely only in the business of developing standards. Many SDOs have sister organizations: code development organizations, third-party certification agencies, testing laboratories, or trade associations. Understanding how these organizations are structured and their roles and responsibilities is crucial in the vast and complex world of market access. It's the first step towards successfully navigating product access in the U.S.

The standards game is a tough one. They are constantly evolving, morphing, and growing. Keeping up with them is essential yet challenging. Knowledge is power. So, arm yourself with understanding.

Taking your eye off standards and regulations – case study of air cleaners in the U.S.

Air cleaners, often called air purifiers, are portable products that improve the air quality of a room or space by removing, destroying or deactivating air contaminants, excluding heating, ventilation, air conditioning (HVAC) systems, HVAC integrated products, and portable room air conditioners and dehumidifiers. In 2021, the U.S. Department of Energy (DOE) determined that air cleaners will be regulated consumer products for energy efficiency under the Energy Policy and Conservation Act (EPCA), as amended. As expected, the DOE referenced an existing and new industry standard developed by the industry trade association's SDO as the basis for federal test procedures used to obtain the federal energy conservation standards, and the U.S. Federal Trade Commission (FTC) is working on the federal labeling requirements. A household-name air cleaner manufacturer vehemently disagrees with the industry trade association's standards and the industry trade association's support of U.S. DOE's rulemaking. Unfortunately, that manufacturer's name is also on the trade association's letters supporting US DOE's rulemakings and adopting the trade association's SDO standards, weakening the manufacturer's opposition. The 1995 governmental requirement for adopting industry standards and the EPCA statutory relationship between U.S. DOE and FTC regulations should have been included in the manufacturer's U.S. compliance strategy. A business strategy integrated with a compliance strategy developed by a knowledgeable consultancy would have avoided this outcome.

How to Successfully Navigate Product Access in the US?

Product access in the U.S. is a voyage of discovery, fraught with challenges and opportunities. Change is the only constant. This rings true, even in the world of market access. Standards evolve. Building and safety codes are revised. Regulations are updated. Legislation is released. The landscape is constantly changing. Manufacturer challenges are often due to a lack of understanding of the relationship between product performance and safety standards, building and safety codes, governmental regulations, voluntary programs, and governmental legislation for a specific market, such as the US. These challenges are not insurmountable with the right people on your side who can unlock the gateway to the marketplace. Call us at Regulosity. We can help!