USA Law and Practice Contributed by: Trevor Keenan, Michelle Byers Graham and Curtis Berglund, Campbell Conroy & O’Neil, P.C.
FDA The FDA corrective action is largely voluntary and consists of either correction or recall. The FDA evalu - ates a potential health hazard based on factors set forth in CFR Title 21, Section 7.41, and assigns a recall classification (Class I, II or III) indicating the product’s relative degree of health hazard. Classes are assigned based on the likelihood and seriousness of a product’s adverse health impact. The company then submits a proposed recall strategy to the FDA consistent with the requirements set forth in CFR Title 21, Section 7.42, and communicates the correction or recall to consumers consistent with the requirements set forth in CFR Title 21, Section 7.49. The FDA will notify the public through its weekly Enforcement Report. See CFR Title 21, Section 7.50. NHTSA The NHTSA requires manufacturers to recall motor vehicles and component parts that fail to comply with FMVSS or that contain safety-related defects that pose an unreasonable risk to motor vehicle safety. Manufacturers have three options for correcting a defect: repair, replace or refund. If a recall is required, manufacturers must notify by first-class mail all regis - tered owners and purchasers of the affected vehicles or components. The requirements for notification are set forth in CFR Title 49, Section 577.5. 1.4 Obligations to Notify Regulatory Authorities The notification requirements concerning potential protect safety issues vary by agency. CPSC The CPSC mandates risk-based and incident-based reporting. Section 15 of the CPSA requires manufac - turers, importers, distributors and retailers to notify the CPSC immediately if they receive information that reasonably supports the conclusion that a product: • fails to comply with an applicable CPSC safety rule or law enforced by the CPSC; • contains a defect that could create a substantial product hazard; or • creates an unreasonable risk of serious injury or death.
Section 15 reporting requirements are found in CFR Title 16, Section 1115. Section 102 of the Child Safety Protection Act requires companies to report certain choking incidents involving children. Code of Federal Regulations Title 16, Section 1117 details the infor - mation that the manufacturer, distributor, retailer and importer should include in the report. Reports under either section must be made within 24 hours of receiv - ing reportable information. If uncertain about whether information is reportable, an entity can conduct an investigation, not to exceed ten working days (with some exceptions). Section 37 of the CPSA requires manufacturers of consumer products to report infor - mation about settled or adjudicated civil actions after the third such action is terminated. Section 37 report - ing requirements are found in CFR Title 16, Section 1116. FDA The FDA’s reporting requirements depend on the product at issue. Drugs and biologics Manufacturers, packagers and distributors of mar - keted prescription drug products that are not the subject of an approved new drug or abbreviated new drug application are required to report all serious and unexpected adverse drug experiences (as defined by the CFR) associated with the use of their products within 15 days of receipt of this information. Report - ing requirements are found at CFR Title 21, Section 310.305. Biologic manufacturers must report serious and unex - pected adverse events within 15 days of learning about the event. Requirements for the report are set forth in CFR Title 21, Section 600.80. Devices Manufacturers must report to the FDA within 30 days when they learn that a device has malfunctioned and would likely cause or contribute to causing serious injury or death if the malfunction reoccurs. See CFR Title 21, Section 803.50 (a). Device importers are required to report to the manu - facturer of the imported device within 30 days a mal - function that would likely cause or contribute to caus -
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