> ## 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-142/
- Published: 2017-07-30T12:00:00.000Z
- Updated: 2026-09-14T22:37:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139257

[**Adjunctive Cardiovascular Status Indicator Into Class 2**](https://www.fdaweb.com/adjunctive-cardiovascular-status-indicator-into-class-2/)  
*Federal Register* notice: FDA classifies as Class 2 the adjunctive cardiovascular status indicator (special controls). 07/28/2017

[**List of Difficult Drugs for Compounding**](https://www.fdaweb.com/list-of-difficult-drugs-for-compounding/)  
*Federal Register* notice: FDA develops a list of drug products and categories of drug products that are difficult to compound. 07/28/2017

[**Device Software Precertification Pilot Program**](https://www.fdaweb.com/device-software-precertification-pilot-program/)  
*Federal Register* notice: CDRH announces a Software Precertification Pilot Program to evaluate a new approach for software products, including a precertification program for assessing companies that perform high-quality software design and testing. 07/28/2017

[**Class 2 Status for Balloon Aortic Valvuloplasty Catheter**](https://www.fdaweb.com/class-2-status-for-balloon-aortic-valvuloplasty-catheter/)  
*Federal Register* notice: FDA classifies the balloon aortic valvuloplasty catheter into Class 2 (special controls). 07/27/2017

[**IRB Waiver of Informed Consent Guidance Availability**](https://www.fdaweb.com/irb-waiver-of-informed-consent-guidance-availability/)  
*Federal Register* notice: FDA announces the availability of a guidance on “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” 07/26/2017

[**Technical Amendment to Civil Money Penalty Rule**](https://www.fdaweb.com/technical-amendment-to-civil-money-penalty-rule/)  
*Federal Register* notice of technical amendment: FDA amends a final rule on “Civil Money Penalty Definitions.” 07/26/2017

[**ICH Revised Guide on CTD Efficacy**](https://www.fdaweb.com/ich-revised-guide-on-ctd-efficacy/)  
*Federal Register* notice: FDA announces the availability of a guidance on “M4E(R2): The CTD — Efficacy,” an International Council for Harmonization revised guidance that standardizes the presentation of benefit-risk information in regulatory submissions. 07/26/2017

[**FDA Workshop on Device Quality Pilot Program**](https://www.fdaweb.com/fda-workshop-on-device-quality-pilot-program/)  
*Federal Register* notice: FDA announces a 10/10 public workshop on “Voluntary Medical Device Manufacturing and Product Quality Program” to announce a proposed framework and preliminary outline of a voluntary pilot program that recognizes an independent assessment of manufacturing and product quality. 07/25/2017

[**FDA Re-org Moves Lab Science/Safety Under Commissioner’s Office**](https://www.fdaweb.com/fda-re-org-moves-lab-science-safety-under-commissioners-office/)  
*Federal Register* notice: FDA announces a restructuring of its Office of the Commissioner, and Office of Operations. 07/25/2017

[**Guidance on Animal Drug User Fee Waivers**](https://www.fdaweb.com/guidance-on-animal-drug-user-fee-waivers/)  
*Federal Register* notice: FDA announces the availability of a guidance for industry on “Animal Drug User Fees and Fee Waivers and Reductions.” 07/25/2017