10519 CONFIDENTIALITY OF INFORMATION

10519.1 The Department will disclose publicly whether there exists a premarket notification submission under this part:

1. (a) Where the device is on the market (such as, introduced or delivered for introduction into interstate commerce for commercial distribution);
2. (b) Where the person submitting the premarket notification submission discloses, through advertising or any other manner, his or her intent to market the device to scientists, market analysts, exporters, or other individuals who are not employees of, or paid consultants to, the establishment and who are not in an advertising or law firm pursuant to commercial arrangements with appropriate safeguards for secrecy; or
3. (c) Where the device is not on the market and the intent to market the device has not been so disclosed, except where the submission is subject to an exception under this section.

10519.2 The Department will not disclose publicly the existence of a premarket notification submission for a device that is not on the market and where the intent to market the device has not been disclosed for ninety (90) days from the date of receipt of the submission, if:

1. (a) The person submitting the premarket notification submission requests in the submission that the Department holds as confidential commercial information the intent to market the device, and submits a written certification to the Department:
2. (1) That the person considers his intent to market the device to be confidential commercial information;
3. (2) That neither the person nor, to the best of his or her knowledge, anyone else, has disclosed through advertising or any other manner, his intent to market the device to scientists, market analysts, exporters, or other individuals, except employees of, or paid consultants to, the establishment or individuals in an advertising or law firm pursuant to commercial arrangements with appropriate safeguards for secrecy;
4. (3) That the person will immediately notify the Department if he or she discloses the intent to market the device to anyone, except employees of, or paid consultants to, the establishment or individuals in an advertising or law firm pursuant to commercial arrangements with appropriate safeguards for secrecy;

(4) That the person has taken precautions to protect the confidentiality of the intent to market the device; and

(5) That the person understands that the submission to the government of false information is prohibited; and

(b) The Department agrees that the intent to market the device is confidential commercial information.

10519.3 Where the Department determines that the person has complied with the procedures described in § 10519.2 with respect to a device that is not on the market and where the intent to market the device has not been disclosed, and the Department agrees that the intent to market the device is confidential commercial information, the Department will not disclose the existence of the submission for ninety (90) days from the date of its receipt by the agency. In addition, the Department will continue not to disclose the existence of such a submission for the device for an additional time when any of the following occurs:

(a) The Department requests in writing additional information regarding the device pursuant to § 10514(h), in which case the Department will not disclose the existence of the submission until ninety (90) days after Department’s receipt of a complete premarket notification submission; or

(b) The Department determines that the device intended to be introduced is a class III device and cannot be marketed without premarket approval or reclassification, in which case the Department will not disclose the existence of the submission unless a petition for reclassification is submitted under the Act and its existence can be disclosed under this chapter.

10519.4 The Department will make a 21 U.S.C. § 360(k) summary of the safety and effectiveness data available to the public within thirty (30) days of the issuance of a determination that the device is substantially equivalent to another device. Accordingly, even when a 21 U.S.C. § 360(k) submitter has complied with the conditions set forth in § 10519.2 and 10519.3, confidentiality for a premarket notification submission cannot be granted beyond thirty (30) days after the Department issues a determination of equivalency.

10519.5 Data or information submitted with, or incorporated by reference in, a premarket notification submission (other than safety and effectiveness data that have not been disclosed to the public) shall be available for disclosure by the Department when the intent to market the device is no longer confidential in accordance with

this section, unless exempt from public disclosure. Upon final classification, data and information relating to safety and effectiveness of a device classified in class I (general controls) or class II (performance standards) shall be available for public disclosure. Data and information relating to safety and effectiveness of a device classified in class III (premarket approval) that have not been released to the public shall be retained as confidential unless such data and information become available for release to the public.

10519.6 The Department may not disclose, or use as the basis for reclassification of a device from class III to class II, any information reported to or otherwise obtained by the Department that falls within the exemption described for trade secrets and confidential commercial information. The exemption does not apply to data or information contained in a petition for reclassification submitted that has been determined to contain no deficiencies that prevent the Department from making a decision on it. Accordingly, all data and information contained in such petitions may be disclosed by the Department and used as the basis for reclassification of a device from class III to class II.

10519.7 For purposes of this section, safety and effectiveness data include data and results derived from all studies and tests of a device on animals and humans and from all studies and tests of the device itself intended to establish or determine its safety and effectiveness.

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