USA Law and Practice Contributed by: Trevor Keenan, Michelle Byers and Curtis Berglund, Campbell Conroy & O’Neil, P.C.
Section 1117 details the information that the manufacturer, distributor, retailer and importer should include in the report. Reports under either section must be made within 24 hours of receiving reportable information. If uncertain about whether information is reportable, an enti - ty can conduct an investigation, not to exceed ten working days (with some exceptions). Sec - tion 37 of the CPSA requires manufacturers of consumer products to report information about settled or adjudicated civil actions after the third such action is terminated. Section 37 reporting 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 marketed prescription drug products that are not the subject of an approved new drug or abbrevi - ated new drug application are required to report all serious and unexpected adverse drug experi - ences (as defined by the CFR) associated with the use of their products within 15 days of receipt of this information. Reporting requirements are found at CFR Title 21, Section 310.305. Biologic manufacturers must report serious and unexpected adverse events within 15 days of learning about the event. Requirements for the report are set forth in CFR Title 21, Section
Device importers are required to report to the manufacturer of the imported device within 30 days a malfunction that would likely cause or contribute to causing serious injury or death. See CFR Title 21, Section 803.40 (b). Reporting requirements are set forth in CFR Title 21, Sections 803.42, 803.52. Manufacturers are also required to report within five days events requiring remedial action to prevent an unrea - sonable risk of substantial harm to public health. See CFR Title 21, Section 803.53. NHTSA The NHTSA requires risk-based and incident- based reporting. Vehicle and equipment manufacturers must sub - mit a Defect and Non-Compliance Information Report to the NHTSA within five working days of concluding that the equipment or vehicle poses a danger or fails to comply with FMVSS. Infor - mation required in the report is set forth in CFR Title 49, Section 573.6. Pursuant to CFR Title 49, Section 579.11, manufacturers must inform the NHTSA of safety recalls or campaigns in foreign countries within five days of deciding to conduct the recall or receiving notice from a foreign gov - ernment that action is required. The TREAD Act requires vehicle and equip - ment manufacturers to report periodically to the NHTSA on a variety of information that could indicate the existence of a potential product safety defect, and to advise the NHTSA of safety recalls or campaigns in foreign countries. Pursu - ant to 49 USC Section 30166 (f), manufacturers are required to submit to the NHTSA copies of their communications about defects and non- compliance with FMVSS.
600.80. Devices
Manufacturers must report to the FDA within 30 days when they learn that a device has malfunc - tioned and would likely cause or contribute to causing serious injury or death if the malfunction reoccurs. See CFR Title 21, Section 803.50 (a).
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