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Steven Niedelman
Insights 13 results
Client Alert
December 19, 2022
FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance
Client Alert
Client Alert
March 1, 2022
The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards
Client Alert
December 30, 2021
FDA Issues Draft Guidances on Transitioning Devices from EUAs and Agency Enforcement Policies
Client Alert
November 15, 2021
FDA Makes First Significant Changes to Premarket Medical Device Software Guidance in 16 Years
Client Alert
April 20, 2021
FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)
Client Alert
February 5, 2021
FDA Appoints Renowned Cybersecurity Researcher to Head Agency's Medical Device Cybersecurity Efforts
Client Alert
October 2, 2020
FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices
Client Alert
September 24, 2020
FDA Proposes New Rule Modifying its “Intended Use” Regulations
Client Alert
August 31, 2017
President Trump Signs FDA User Fee Reauthorization Bill into Law – A Relief for the Medical Device Industry
Article
October 31, 2014
Recall Or Enhancement? Read These Medical Device Rules
Client Alert
October 27, 2014
FDA Holds Webinar Discussing Final Guidance on Custom Device Exemptions