> ## 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-76/
- Published: 2022-04-10T12:00:00.000Z
- Updated: 2026-09-14T17:40:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151564

**2 Device Guides on Performance Criteria**  
04/08/2022 *Federal Register* notice: FDA has made available two guidance documents for the Safety and Performance Based Pathway. The first is entitled “Surgical Sutures — Performance Criteria for Safety and Performance Based Pathway” and the other is “Orthopedic Fracture Fixation Plates — Performance Criteria for Safety and Performance Based Pathway.” To view the notice, click [here](https://public-inspection.federalregister.gov/2022-07684.pdf?ref=fdaweb.com).  

**Final Guide on ICH Drug Study Considerations**  
04/08/2022 *Federal Registe*r notice: FDA is making available a final guidance entitled “E8(R1) General Considerations for Clinical Studies.” The International Council for Harmonization document describes internationally accepted principles and practices for the design and conduct of drug/biologic clinical studies. It also provides an overview of the types of clinical studies that may be performed and data sources used during the product’s lifecycle. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-07690.pdf?ref=fdaweb.com).  

**Guide on Hepatitis B Infection Drugs**  
04/07/2022 *Federal Register* notice: FDA has made available a final guidance entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment” that provides general recommendations on the clinical development of such products. It includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and Phase 3 safety and efficacy trials. It also addresses Phase 3 trial design considerations and efficacy endpoints for the development of finite duration therapies for treating chronic infection. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-04-07/pdf/2022-07397.pdf?ref=fdaweb.com).  

**Public Meeting on Device User Fee Reauthorizatio**n  
04/06/2022 *Federal Register* notice: FDA is announcing a 4/19 virtual public meeting entitled “Medical Device User Fee Amendments” to discuss proposed recommendations for the Medical Device User Fee Amendments reauthorization for fiscal years 2023 through 2027\. The meeting is intended to give the public an opportunity to present its views on the recommendations. FDA says it will then consider the public input and revise the recommendations as necessary. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-04-07/pdf/2022-07451.pdf?ref=fdaweb.com).