Title 21

SECTION 861.20

861.20 Summary of standards development process.

§ 861.20 Summary of standards development process.

The procedure by which a performance standard for a device may be established, amended, or revoked is as follows:

(a) The Food and Drug Administration (FDA) will publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any performance standard for a device.

(1) A notice of proposed rulemaking for the establishment or amendment of a performance standard for a device will:

(i) Set forth a finding, with supporting justification, that the performance standard is appropriate and necessary to provide reasonable assurance of the safety and effectiveness of the device;

(ii) Set forth proposed findings with respect to the risk of illness or injury that the performance standard is intended to reduce or eliminate;

(iii) Invite interested persons to submit to the Food and Drug Administration, within 30 days of the publication of the notice, requests for changes in the classification of the device pursuant to § 860.132 of this chapter, based on new information relevant to the classification; and

(iv) Invite interested persons to submit an existing performance standard for the device, including a draft or proposed performance standard, for consideration by the Commissioner of Food and Drugs.

(2) A notice of proposed rulemaking for the revocation of a performance standard will set forth a finding, with supporting justification, that the performance standard is no longer necessary to provide reasonable assurance of the safety and effectiveness of a device.

(b) A notice under this section will provide for a comment period of not less than 60 days.

(c) If, after publication of a notice under paragraph (a) of this section, FDA receives a request to change the classification of the device, FDA will, within 60 days of the publication of the notice and after consultation with the appropriate panel under § 860.125 of this chapter, either deny the request or give notice of its intent to initiate a change in the classification under § 860.130.

(d) If FDA initiates a rulemaking proceeding under paragraph (a) of this section, FDA will:

(1) Complete the proceeding and establish the performance standard for the device in accordance with this part and § 10.40 of this chapter; or

(2) Terminate the proceeding by publishing in the Federal Register a notice announcing such termination and the reasons therefor and, unless the proceeding is terminated because the device is a banned device, initiate a proceeding in accordance with section 513(e) of the act to reclassify the device; or

(3) Take other appropriate action.

[57 FR 58404, Dec. 10, 1992]

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