Business · 06/03/2014Updated: 10/17/2026 · 1 min read

FDA Publishes Report on Premarket Notification Requirements for Medical Devices

Summary

The US Food and Drug Administration (FDA) has posted a report on its website regarding proposed changes to the requirements for modifying legally marketed medical devices, and is accepting public comments through a dedicated docket.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

Add your company to Business Communicator

We monitor business sources and connect attention with companies, profiles and services available in Business Communicator.

Create a free company profile Explore businesses on Business Maps →

Create a free company profile →

Explore insights

Business insights →

Healthcare Business News Global Markets News Trade Regulation News Business Technology News Fintech for Business: Payments & Banking News Supply Chain News

Related business signals

Business · 9/16/2026

Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Pathogen-Agnostic Sequencing

The Food and Drug Administration (FDA) announces a public advisory committee meeting of the Microbiology Devices Panel to discuss pathogen-agnostic sequencing for emergency preparedness and response efforts.

Read summary →

Business · 9/17/2026

FDA Grants Partial Exemption to Medical Devices

The FDA has finalized a rule exempting certain radiology computer-aided detection and diagnosis devices from premarket notification requirements, following a petition filed in 2025 and denied in 2026.

Read summary →

Business · 9/16/2026

Food and Drug Administration Announces Proposed Collection of Information for Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Read summary →

Business · 9/14/2026

FDA Submits Collection of Information for OMB Review

Read summary →

Business · 10/5/2026

CDC Requests Public Comment on Respiratory Protective Devices Data Collection

The Centers for Disease Control and Prevention (CDC) is seeking public input on a proposed data collection project related to Respiratory Protective Devices, as required by the Paperwork Reduction Act of 1995, to inform the approval certification activities under 42 CFR part 84.

Read summary →

Business · 9/17/2026

Proposed Data Collection Activity for Diaper Distribution Demonstration and Research Pilot Beneficiary and Organizational Survey

The Administration for Children and Families, Department of Health and Human Services, is proposing to continue collecting data on diaper need and outcomes for beneficiaries of the Diaper Distribution Demonstration and Research Pilot, with proposed changes to the Beneficiary Survey and addition of an Organizational Survey.

Read summary →