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# CDRH Pioritized Guidance Listing for FY 2021
- URL: https://www.fdaweb.com/cdrh-pioritized-guidance-listing-for-fy-2021/
- Published: 2020-10-16T12:00:00.000Z
- Updated: 2026-09-14T16:32:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147896

CDRH has released a [list of prioritized guidance ](https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2021-fy-2021?ref=fdaweb.com)documents that it intends to publish this fiscal year (FY 2021). Final guidance topics the Center intends to publish include Surgical Staplers, Safer Technologies Program for Medical Devices, Clinical Decision Support Software, Device-Specific Criteria Guidance for Safety and Performance Based Pathway Implementation, and Product Labeling for Laparoscopic Power Morcellators. Draft guidance topics planned for FY 2021 are:

- Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
- Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order
- Computer Software Assurance for Manufacturing and Quality System Software
- Remanufacturing of Medical Devices
- Case for Quality Voluntary Improvement Program
- Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation
- Transition Plan for Medical Devices Distributed Under Enforcement Policies or Emergency Use Authorization During the Covid-19 Public Health Emergency
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Unique Device Identification: Policy on Enforcement of GUDID Submission Requirements for Certain Class I Devices
- Medical Device Shortages - Implementation of Section 506(J) of the Federal Food, Drug, and Cosmetic Act
- Content of Premarket Submissions for Software Contained in Medical Devices
- Electronic Submission Template for Premarket Notification (510(k)) Submissions