Section 22-B10832. PLANS FOR THE REPLACEMENT OF ELECTRONIC PRODUCTS

 

10832.1Every plan for replacing an electronic product with a like or equivalent product shall be submitted to the Department in writing, and in addition to other relevant information which the Department may require, shall include:

(a) Identification of the product to be replaced;

 

(b) A description of the replacement product in sufficient detail to support the manufacturer's contention that the replacement product is like or equivalent to the product being replaced;

 

(c) The approximate number of defective product units which have left the place of manufacture;

 

(d) The manner in which the replacement operation will be effected including the procedure for obtaining possession of the product to be replaced;

 

(e) A time limit, reasonable, in light of the circumstances for completion of the replacement;

 

(f) The steps which the manufacturer will take to insure that the defective product will not be reintroduced into commerce, until it complies with each applicable District standard and has no defect relating to the safety of its use;

 

(g)The system by which the manufacturer will provide reimbursement for any expenses for transportation of such product incurred in connection with effecting the replacement; and

(h)The text of the statement which the manufacturer will send to the persons specified in § 10823.1(b) of this chapter informing such persons:

 

(1) That the manufacturer, at its expense, will replace the electronic product involved;

 

(2) Of the method by which the manufacturer will obtain possession of the product and effect the replacement;

 

(3)That the manufacturer will reimburse such persons for any transportation expenses incurred in connection with effecting such replacement; and

 

(4)Of the manner in which such reimbursement will be made.

 

10832.2An assurance that the manufacturer will provide the Department with progress reports on the effectiveness of the plan, including the number of electronic products replaced.

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).