Regulatory Compliance

Our lawyers have experience in domestic and international regulatory compliance. Recently, we have worked on compliance issues with these specific regulations:

U.S. Federal Regulations:

  • Consumer Product Safety Improvement Act (CPSIA);
  • Consumer Product Safety Commission regulations (CPSC);
  • Fabric Flammability Act (FFA);
  • Federal Hazardous Substances Act (FHSA);
  • Federal Aviation Regulations (FARs);
  • FDA Regulations (medical devices, OTC drugs, and animal drugs).

U.S. State Regulations:

  • California Proposition 65 (Cal Prop 65) (hazardous substances);
  • Cal. Health & Safety Code. §§ 25214.9 –25214.10.2 (California RoHS);
  • Cal. Civ. Code §§ 1791 – 1795 (2008)(Assistive Device Lemon Law);
  • Florida adoption of NFPA Standard 1, Fire Protection Code and Life Safety Code, Pamphlet 101;
  • Florida Fire Prevention Code, Fla. Stat. §633 (2001) (fire alarms and smoke detectors);
  • N.Y. Bldg. Code § 907.2.10 (2007); N.Y. Exec. Law §378 (5-b) (2007)(single- and multiple-station smoke alarms);
  • San Francisco Fire Code § 909 (a) (2007) (fire alarms and smoke detectors).

International Regulations:

  • EU General Product Safety (GPS) Directive 92/59/EEC;
  • UK Waste Electrical and Electronic Equipment (WEEE) Directive 2002/96/EC;
  • EU Restriction of Hazardous Substances (RoHS) Directive 2002/95/EC;
  • EU Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH);
  • EU Low Voltage Directive 2006/95/EC;
  • Canadian Hazardous Products Act (R.S., 1985, c. H-3);
  • Canadian Hazardous Products (Toys) Regulations (C.R.C., c. 931).

Specifically, our lawyers have worked with compliance issues governing aviation components, medical devices, aerosols, industrial equipment, consumer products, electronic devices, information technology, automobile components, medical devices, animal drugs, pharmaceuticals, solvents, sealants, adhesives, and cleaners.

Product Hazards

From Initial Concept through Retail Distribution, our lawyers have implemented product safety criteria directly into the manufacturing process in a way that builds upon your existing manufacturing system. These criteria demonstrate your company’s deliberate emphasis on product safety. Your action on these criteria protects the product user and prevents product liability events.

We have experience working with your toxicologists, industrial hygienists, mechanical and chemical engineers to

  • prepare comprehensive safety protocols
  • require compliance from foreign vendors with material and design specifications,
  • write contemporaneous, defensive engineering documents, including close-the-loop memoranda,
  • perform specific hazard analyses,
  • develop and integrate internal testing criteria, and
  • adopt industry standards.

We have also

  • written specific product identification systems,
  • prepared warranties and disclaimers,
  • prepared vendor purchase orders and supply contracts,
  • prepared company document retention systems
  • worked directly with Customer Service Representatives to sharpen intake data, and
  • recorded intake data for use in R & D, determining foreseeable use, and preparing design change orders.

We are not engineers; we are lawyers. We reduce your product hazards on multiple fronts through a multi-disciplinary effort that joins your resources with the strongest available liability protection. Our mission is product safety through liability protection.

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