> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-207/
- Published: 2018-12-09T12:00:00.000Z
- Updated: 2026-09-15T00:49:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142999

[**Comments Sought on Real World Evidence Program**](https://www.fdaweb.com/comments-sought-on-real-world-evidence-program/)  
*Federal Register* notice: FDA seeks comments on a CDER/CBER framework for implementing a program to evaluate the potential use of real-world evidence in regulatory decision making. 12/07/2018

[**Proposed Rule on De Novo Classification Process**](https://www.fdaweb.com/proposed-rule-on-de-novo-classification-process/)  
*Federal Register* proposed rule: FDA proposes to establish requirements for its medical device De Novo classification process. 12/07/2018

[**Draft Guide on Companion Diagnostics**](https://www.fdaweb.com/draft-guide-on-companion-diagnostics/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.” 12/07/2018

[**Draft Guide on Blood Bacterial Rick Controls**](https://www.fdaweb.com/draft-guide-on-blood-bacterial-rick-controls/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.” 12/06/2018

[**Info Collection Extension for Environmental Impact Considerations**](https://www.fdaweb.com/info-collection-extension-for-environmental-impact-considerations/)  
*Federal Register* notice: FDA submits to OMB an information collection extension entitled “Environmental Impact Considerations.” 12/06/2018

[**Info Collection Extension for Drug Supply Chain Guide**](https://www.fdaweb.com/info-collection-extension-for-drug-supply-chain-guide-2/)  
*Federal Register* notice: FDA has submitted to OMB an information collection extension entitled “Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” 12/05/2018

[**InSightecs Exablate Regulatory Review Period Determined**](https://www.fdaweb.com/insightecs-exablate-regulatory-review-period-determined/)  
*Federal Register* notice: FDA determines for patent extension purposes the regulatory review period for InSightec’s medical device Exablate. 12/05/2018