Jonathan Havens on Medical Devices

CMS Proposes Medicare Coverage of Certain New Medical Devices, Clarification of “Reasonable and Necessary” Definition

On September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule that, if finalized, would establish a Medicare coverage pathway to provide Medicare beneficiaries with...more

9/17/2020 / Centers for Medicare & Medicaid Services (CMS) , Executive Orders , Food and Drug Administration (FDA) , Medical Devices , Medicare

FDA Further Outlines Plans to Strengthen and Modernize 510(k) Pathway

Agency continues to promote use of "robust performance criteria" and "modern predicate devices" - On January 22, 2019, the U.S. Food and Drug Administration (FDA or the Agency) detailed in a Final Guidance document the...more

1/29/2019 / 510(k) RTA , Food and Drug Administration (FDA) , Medical Devices

FDA Announces Plans to Significantly Change Medical Device 510(k) Clearance Program

On November 26, 2018, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), issued an extensive...more

11/29/2018 / 510(k) RTA , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry

FDA Releases Medical Device Cybersecurity Draft Guidance

In recognition of the increasing prevalence of connected medical devices, and the potential cybersecurity vulnerability of the same, the U.S. Food and Drug Administration (FDA or the Agency) issued on October 18, 2018 a draft...more

10/30/2018 / Comment Period , Cybersecurity , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Popular

FDA Takes Further Actions to Encourage Digital Health Innovation, Issuing CDS, Medical Software, and SaMD Guidance Documents

Today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is issuing three new, significant policy documents to advance FDA’s approach to the development and...more

12/8/2017 / Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Software

Medical Device Update: FDA Releases Device Change Final Guidances and Breakthrough Devices Draft Guidance, Qualifies First Device...

Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) took a number of steps to “advance medical device innovation and help patients gain faster access to beneficial technologies,” as characterized by FDA...more

10/26/2017 / 510(k) RTA , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Modification

House Passes FDA Reauthorization Act; Would Reauthorize Key User Fee Programs and Lengthen Medical Device Malfunction Reporting...

Last week, the U.S. House of Representatives (the House) passed by voice vote the FDA Reauthorization Act of 2017 (FDARA or the Act). Introduced on May 16, 2017 by House Energy and Commerce Committee Chairman Greg Walden...more

7/24/2017 / FDA Reauthorization Act , Food and Drug Administration (FDA) , GDUFA , Medical Device User Fee Program (MDUFA IV) , Medical Devices , PDUFA , Proposed Legislation , User Fees

FDA to Exempt Over 1,000 Types of Medical Devices from Premarket Notification Requirements

On March 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) identified a list of 1,003 types of Class II medical devices that, when finalized, will be exempt from the Agency’s premarket notification (i.e.,...more

3/16/2017 / 510(k) RTA , Food and Drug Administration (FDA) , Manufacturers , Medical Devices

Jonathan Havens

Saul Ewing LLP

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