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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-84/
- Published: 2016-03-27T12:00:00.000Z
- Updated: 2026-09-14T20:51:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135200

**DEVICES** 
  
**FDA Adds Device Patient Engagement Advisory Committee**  
*Federal Register* Final rule: FDA is amending the standing advisory committees’ regulations to add the Patient Engagement Advisory Committee. Its function is to provide advice to the commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. Topics that may be considered by the commissioner include: agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes, and device-related quality of life or health status issues. The committee provides relevant skills and perspectives in order to improve communication of benefits, risks, and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. The committee will be composed of a core of nine voting members including the chair. To view this final rule, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-21/pdf/2016-06240.pdf?ref=fdaweb.com)  
  
**Guidance on Radiofrequency-Induced Heating of MR Devices**  
*Federal Register* Notice: FDA is making available a guidance entitled *Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices*. FDA is confronted with an increasing number of premarket submissions that include an MR Conditional labeling claim for multiconfiguration passive medical devices. The assessment of radiofrequency (RF)-induced heating of such devices, typically comprised of many parts, strongly depends on the specific device geometry and can therefore lead to a prohibitively large number of test cases. This guidance provides an approach to reduce the number of possible device configurations to a manageable number, and it provides guidance on how to assess the RF-induced device heating for an individual configuration. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM452644?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-22/pdf/2016-06361.pdf?ref=fdaweb.com).  
  
**FDA Propose Ban of Powdered Surgical/Exam Gloves**  
*Federal Register* Proposed rule: FDA has determined that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. FDA is proposing these devices be banned. Comments should be submitted by 6/20\. To view this proposed rule, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-22/pdf/2016-06360.pdf?ref=fdaweb.com).  
  
**HUMAN DRUGS** 
  
**FDA Plans Public Conference on Manufacturing Goals**  
*Federal Register* Notice: FDA and the Parenteral Drug Association will co-sponsor a public conference 9/12-14 entitled: “Aligning Manufacturing Goals with Patient Needs through Successful Innovation and Compliance.” It will cover current issues affecting the industry as well as explore strategies to facilitate the development and continuous improvement of safe and effective medical products. The conference will be held from 7 a.m. to 7:30 p.m.; 9/13, from 7 a.m. to 9:30 p.m. and 9/14, from 7 a.m. to 12:30 p.m. at the Renaissance Washington, DC Downtown Hotel, 999 Ninth Street NW., Washington, DC. Contact **Wanda Neal**, (301) 656-5900, ext. 111\. or **Ken Nolan**, (301) 796-8629, email: kenneth.nolan@fda.hhs.gov. To view this notice, click [here. ](https://www.gpo.gov/fdsys/pkg/FR-2016-03-22/pdf/2016-06366.pdf?ref=fdaweb.com)  
**Guidance on Evaluating Generic Opioid Abuse Deterrence**  
*Federal Register* Notice: FDA is making available a draft guidance: *General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products*. It recommends studies, including comparative in vitro studies, that should be conducted to demonstrate that a proposed generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug. To download this guidance, click [here.](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM492172.pdf?ref=fdaweb.com) To view this notice, click [here. ](https://www.gpo.gov/fdsys/pkg/FR-2016-03-25/pdf/2016-06766.pdf?ref=fdaweb.com)