Requires manufacturer of recalled medical devices to provide replacement device or pay for replacement device under certain circumstances.
Impact
The bill is designed to enhance consumer protection in the medical device market by ensuring prompt action from manufacturers once a recall is issued. By requiring compliance within 30 days of a recall, S2427 aims to prevent potential health risks arising from continued use of defective or harmful medical devices. This statute could significantly influence the behavior of manufacturers as they may need to enhance their product safety protocols and recall mechanisms to mitigate possible penalties for non-compliance.
Summary
Senate Bill S2427 mandates that manufacturers of recalled medical devices must provide a replacement device or cover the costs for a replacement device under specific circumstances. The bill defines a 'manufacturer' as any individual or entity engaged in the manufacturing or assembly of medical devices, as per the definitions set forth in the Federal Food, Drug and Cosmetic Act. This ensures that consumers are not left without viable alternatives following a recall, as they will either receive a new device at no cost or have the manufacturer pay for a device from another source if the original manufacturer cannot provide one.
Contention
One notable point of contention surrounding S2427 is the enforcement of its provisions and the implications it may have on medical device manufacturers. Critics may argue that such regulations could impose undue burdens on smaller manufacturers who might lack the capital or resources to quickly provide replacements or cover costs. The penalties for violations, which can reach up to $20,000 for repeated offenses, may also be seen as an excessive financial risk for smaller entities within the industry. This may lead to discussions about balancing consumer protection with the economic viability of medical device companies.
An Act to Require the Cooperation of Original Manufacturers of Electronic Devices to Facilitate the Repair of Those Devices by Device Owners and Independent Repair Providers
Relative to tenant and contract manufacturers of beer, wine, and liquor; allowing pharmacists to administer influenza, COVID-19, and other FDA licensed vaccines without explicit approval from the general court; and, restricting the purchase of real property on or around military installations.