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Steven Niedelman
Insight 8 results
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
Client Alert
October 16, 2014
FDA Issues Final Medical Device Recalls Guidance