Section 22-B10514. INFORMATION REQUIRED IN A PREMARKET MODIFICATION SUBMISSION

 

10514.1Each premarket notification submission shall contain the following information:
 

(a)The device name, including both the trade or proprietary name and the common or usual name or classification name of the device;
 

(b) The establishment registration number, if applicable, of the owner or operator submitting the premarket notification submission;

 

(c) The class in which the device has been put under 21 U.S.C. § 360c and, if known, its appropriate panel; or, if the owner or operator determines that the device has not been classified under such section, a statement of that determination and the basis for the person's determination that the device is not so classified;

 

(d)Action taken by the person required to register to comply with the requirements under 21 U.S.C. § 360d for performance standards;
 

(e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use. Where applicable, photographs or engineering drawings should be supplied;

 

(f) A statement indicating the device is similar to or different from other products of comparable type in commercial distribution, accompanied by data to support the statement. This information may include an identification of similar products, materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device;

 

(g) Where a person required to register intends to introduce into commercial distribution a device that has undergone a significant change or modification that could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication for use, the premarket notification submission must include appropriate supporting data to show that the manufacturer has considered what consequences and effects the change or modification or new use might have on the safety and effectiveness of the device;

 

(h) A 21 U.S.C. § 360(k) summary as described in § 10517 or a 21 U.S.C. § 360(k) statement as described in § 10518;

 

(i) A financial certification or disclosure statement or both;

 

(j) For submissions claiming substantial equivalence to a device which has been classified into class III under the Act:

 

(1)Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990; and
 

(2) For which no final regulation requiring premarket approval has been issued under 21 U.S.C. § 360e(b), a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III summary). The 21 U.S.C. § 360(k) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (class III certification), as described in § 10518. This information does not refer to information that already has been submitted to the Department under the Act. Department may require the submission of the adverse safety and effectiveness data described in the class III summary or citation;

 

(k) A statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the premarket notification is truthful and accurate and that no material fact has been omitted; and

 

(l) Any additional information regarding the device requested by the DOH that is necessary for the Department to make a finding as to whether or not the device is substantially equivalent to a device in commercial distribution. A request for additional information will advise the owner or operator that there is insufficient information contained in the original premarket notification submission for the Department to make this determination and that the owner or operator may either submit the requested data or a new premarket notification containing the requested information at least ninety (90) days before the owner or operator intends to market the device, or submit a premarket approval application in accordance with21 U.S.C. § 360e.  If the additional information is not submitted within thirty (30) days following the date of the request, the Department will consider the premarket notification to be withdrawn.

 

 

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).