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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-208/
- Published: 2019-01-06T12:00:00.000Z
- Updated: 2026-09-15T00:52:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143054

**FDA Webview** has posted below the *Federal Register* notices published during our annual end-of-year holiday break.

**DEVICES**

*Federal Register* final rule: FDA has issued a final rule to amend its regulations governing medical device classification and reclassification to conform to the applicable provisions of the Food, Drug, and Cosmetic Act as amended by the FDA Safety and Innovation Act (FDASIA). The agency is taking this action to codify the procedures and criteria to provide for classification in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2018-12-17/pdf/2018-27015.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA has made available a final guidance entitled “Manufacturing Site Change Supplements: Content and Submissions; Guidance for Industry and Food and Drug Administration Staff.” The document describes the decision-making steps that FDA recommends to determine whether a PMA supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device. This guidance also discusses the general factors FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2018-12-17/pdf/2018-27237.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA has made available a draft guidance entitled “Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.” The document pertains to the recordkeeping, reporting, manufacturing, importing, and installation of electronic products, as defined in FDA regulations. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2018-12-17/pdf/2018-27236.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA has issued a final order to reclassify the electroconvulsive therapy device, which is used in treating catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, into Class 2 (special controls). To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2018-12-26/pdf/2018-27809.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA has announced its intent to consider the appropriate classification of hyaluronic acid (HA) intra-articular products intended for treating pain in osteoarthritis (OA) of the knee. Although HA products intended for this use have been regulated as devices, the agency says the current published scientific literature supports that it achieves its primary intended purpose of treatment through chemical action within the body. Because HA for this use may not meet the definition of a device, sponsors of HA products who intend to submit a PMA are encouraged to obtain an informal or formal classification and jurisdiction determination through a pre-request for designation or request for designation from FDA prior to submission. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2018-12-18/pdf/2018-27351.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA has made available a final guidance entitled “Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff.” The document describes policies that FDA intends to use to implement the new Breakthrough Devices Program, established by the 21st Century Cures Act. The program supersedes and combines elements from FDA’s Expedited Access Pathway, which was intended to facilitate the development and expedite review of certain devices that demonstrate the potential to address unmet medical needs, as well as the priority review program, which implemented statutory criteria for granting priority review to PMAs and applied those criteria to other types of premarket submissions for medical devices. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2018-12-19/pdf/2018-27433.pdf?ref=fdaweb.com).

**DRUGS**

*Federal Register* proposed rule; comment period extension: FDA has extended the comment period on an 11/15/2018 proposed rule that would implement statutory changes made by the 21st Century Cures Act to allow for a waiver or alteration of informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. Comments now are being accepted until 2/13\. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2018-12-20/pdf/2018-27519.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA has made available a draft guidance entitled “Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.” The document discusses how a person seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA may submit such a draft. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2018-12-21/pdf/2018-27657.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA has issued an order debarring **Ranjan Bhandari** for three years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Bhandari was convicted of a misdemeanor for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2018-12-27/pdf/2018-27951.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA has made available a draft guidance entitled “Draft Guidance on Linaclotide.” The document, when finalized, will provide product-specific recommendations on the design of bioequivalence studies to support ANDAs for linaclotide oral capsules. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2018-12-28/pdf/2018-28213.pdf?ref=fdaweb.com).

**VETERINARY**

*Federal Register* notice: FDA has made available a draft guidance #259 entitled “Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV.” The document discusses the stability data package for a new veterinary drug substance and medicinal product to be included in a registration or application. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2018-12-28/pdf/2018-28219.pdf?ref=fdaweb.com).