Source: https://www.global-regulation.com/law/united-states/30649/performance-standards-for-ionizing-radiation-emitting-products%253b-fluoroscopic-equipment%253b-correction.html
Timestamp: 2018-08-14 11:25:24
Document Index: 620822901

Matched Legal Cases: ['§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020']

Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Correction (United States)
Link to law: https://www.federalregister.gov/articles/text/raw_text/201/508/360.txt
• Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Docket No. FDA-2015-N-0828 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.
FDA is correcting a drafting error regarding fluoroscopic equipment measurement in § 1020.32 (21 CFR 1020.32). We are publishing this direct final rule because it is intended to make a noncontroversial amendment to § 1020.32, and we do not anticipate any significant adverse comments. Specifically, this amendment changes the words “any linear dimension” in the current regulation to read “every linear dimension” (§ 1020.32(b)(4)(ii)(A)). The alternative performance standard, § 1020.32(b)(4)(ii)(B), currently contains the same phrase but remains unchanged. We are amending the language to make the performance standards mutually exclusive. This will ensure clarity and improve the accuracy of the regulations.
FDA ultimately incorporated the phrase in two places, potentially reducing the clarity of the rule (70 FR 33998 at 34040). Section 1020.32(b)(4)(ii) sets performance standards based on a threshold, so the language for each standard should be mutually exclusive. That is, only one standard, and not the other, should apply to the image receptor in question. However, some image receptors may have linear dimensions that are both greater than and less than 34 cm, for example, receptors with a hexagonal shape. In such cases, the performance standards may not be mutually exclusive, so both standards may appear to apply. This direct final rule amends § 1020.32(b)(4)(ii)(A) to read “every linear dimension” to ensure the standards are mutually exclusive. The amendment will improve the clarity and accuracy of the regulations.
Consistent with FDA's procedures on direct final rulemaking, we are publishing a companion proposed rule elsewhere in this issue of the Federal Register . That proposed rule is identical in substance to this direct final rule. The companion proposal will provide a procedural framework to finalize a new rule in the event we withdraw this direct final rule because we receive significant adverse comment. The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule. We will consider any comments that we receive in response to the companion proposed rule to be comments also regarding this direct final rule and vice versa.
If we withdraw this direct final rule, FDA will consider all comments that we received regarding the companion proposed rule as we develop a final rule through the usual notice-and-comment procedures of the APA (5 U.S.C. 552a, et seq. ). If we receive no significant adverse comments during the specified comment period regarding this direct final rule, we intend to publish a confirmation document in the Federal Register within 30 days after the comment period ends.
This rule, if finalized, would amend § 1020.32. FDA's authority to modify § 1020.32 arises from the same authority under which FDA initially issued this regulation, the device and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371, and 381).
Electronic products, Medical devices, Radiation protection, Reporting and recordkeeping requirements, Television, X-rays.
21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371, 381.
2. Revise § 1020.32(b)(4)(ii)(A) to read as follows:
§ 1020.32