Section 22-B10824. DETERMINATION BY THE DEPARTMENT OF HEALTH THAT PRODUCT FAILS TO COMPLY OR HAS A DEFECT

 

10824.1If, the Department through testing, inspection, research, or examination of reports or other data, determines that any electronic product does not comply with an applicable standard issued pursuant to the Act or has a defect, he or she shall immediately notify the manufacturer of the product in writing specifying:
 

(a) The defect in the product or the manner in which the product fails to comply with the applicable standard;

 

(b)The Department's findings, with references to the tests, inspections, studies, or reports upon which such findings are based; and

 

(c)A reasonable period of time during which the manufacturer may present his views and evidence to establish that there is no failure of compliance or that the alleged defect does not exist or does not relate to safety of use of the product by reason of the emission of electronic product radiation.
 

10824.2The manufacturer shall have an opportunity for a regulatory hearing before the Department.

 

10824.3Every manufacturer who receives a notice under § 10824.1 shall immediately advise the Department in writing of the total number of such product units produced and the approximate number of such product units which left the place of manufacture.

 

10824.4If, after the expiration of the period of time specified in the notice, the Department determines that the product has a defect or does not comply with an applicable standard and the manufacturer has not applied for an exemption, he or she shall direct the manufacturer to furnish the notification to the persons specified in § 10823.1(b) in the manner specified in § 10826. The manufacturer shall within fourteen (14) days from the date of receipt of such directive furnish the required notification.

 

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).