Bill Text: NJ A1399 | 2024-2025 | Regular Session | Introduced
Bill Title: Requires manufacturer of recalled medical devices to provide replacement device or pay for replacement device under certain circumstances.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced) 2024-01-09 - Introduced, Referred to Assembly Consumer Affairs Committee [A1399 Detail]
Download: New_Jersey-2024-A1399-Introduced.html
STATE OF NEW JERSEY
221st LEGISLATURE
PRE-FILED FOR INTRODUCTION IN THE 2024 SESSION
Sponsored by:
Assemblywoman SHAMA A. HAIDER
District 37 (Bergen)
SYNOPSIS
Requires manufacturer of recalled medical devices to provide replacement device or pay for replacement device under certain circumstances.
CURRENT VERSION OF TEXT
Introduced Pending Technical Review by Legislative Counsel.
An Act concerning medical device manufacturers and supplementing Title 56 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. a. As used in this act:
"Manufacturer" means a person engaged in the business of manufacturing or assembling medical devices.
"Medical device" or "device" means a "device" as defined in subsection (h) of section 201 of the "Federal Food, Drug and Cosmetic Act," 52 Stat. 1040, (21 U.S.C. s.321).
b. If a recall is issued that requires a consumer to stop using a medical device or to return a medical device to the manufacturer, the manufacturer shall provide a replacement medical device to a consumer at no cost, or, if no replacement is available from the manufacturer, purchase a replacement medical device available from another manufacturer for the consumer. A manufacturer shall comply with the provisions of this subsection as soon as practicable but no later than 30 days after the recall is issued.
c. A violation of subsection b. of this section shall be an unlawful practice pursuant to P.L.1960, c.39 (C.56:8-1 et seq.).
2. This act shall take effect immediately.
STATEMENT
This bill requires a manufacturer of a recalled medical device to provide a replacement device or pay for a replacement device under certain circumstances.
Under the provisions of this bill, if a recall is issued that requires a consumer to stop using a medical device or to return a medical device to the manufacturer, the manufacturer is to provide a replacement medical device to a consumer at no cost, or, if no replacement is available from the manufacturer, to purchase a replacement medical device available from another manufacturer for the consumer. The bill provides that a manufacturer is to comply with the provisions of this section as soon as practicable but no later than 30 days after the recall is issued.
The bill defines
"manufacturer" to mean a person engaged in the business of manufacturing or
assembling medical devices.
A violation of the bill's provisions is an unlawful practice under the consumer fraud act, P.L.1960, c.39 (C.56:8-1 et seq.). An unlawful practice is punishable by a monetary penalty of not more
than $10,000 for a first offense and not more than $20,000 for any subsequent offense. In addition, a violation can result in cease and desist orders issued by the Attorney General, the assessment of punitive damages, and the awarding of treble damages and costs to the injured.
