Michele L. Buenafe

Michele L. Buenafe

Morgan Lewis

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Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

10/30/2014 - FDA Final Guidance Manufacturers Medical Devices Pharmaceutical Manufacturers Product Enhancements Product Recalls

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more

8/26/2014 - FDA FDASIA FFDCA Manufacturers Medical Devices

Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged

On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” Device manufacturers should be aware of key...more

8/6/2014 - FDA Medical Devices Premarket Approval Applications Section 510

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

7/23/2014 - Draft Guidance FDA Final Guidance Healthcare Manufacturers Marketing Medical Devices Unique Device Identifiers

FDA to Cease Active Regulation of MDDS and Other Health IT Devices

The draft guidance also enables some health IT manufacturers to avoid the device tax. The Food and Drug Administration (FDA) took an unusual step on June 20 by issuing new draft guidance that states its intent to not...more

6/24/2014 - FDA Health Information Technologies Healthcare Medical Devices Mobile Devices

FDA Issues Long-Awaited Final Guidance on Mobile Medical Applications

Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients. On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more

9/26/2013 - FDA Final Guidance Mobile Apps Mobile Devices Telemedicine

FDA Issues New Medical Device Reporting Guidance

Device manufacturers should be aware of new issues and policy changes, which include the removal of the "two-year rule" for malfunctions. On July 9, the U.S. Food and Drug Administration (FDA) issued a new draft...more

7/16/2013 - FDA Manufacturers Medical Devices Reporting Requirements

FDA Taking on Cybersecurity Risks for Medical Devices

FDA issues safety communication and draft guidance clarifying that manufacturers are responsible for addressing cybersecurity risks related to their medical devices....more

6/17/2013

Final Sunshine Act Arrives: Now the Hard Part

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

3/8/2013 - Affordable Care Act CMS Healthcare Manufacturers Medical Devices Pharmaceutical Physicians Reporting Requirements Sunshine Act

IRS Issues Device Tax Regulations; Industry Braces for 2013 Implementation

Pending the January 1 effective date, final regulations and interim guidance on the medical device excise tax provide some clarity but leave many questions unanswered. On December 7, the Internal Revenue Service (IRS)...more

12/12/2012 - Excise Tax IRS Medical Devices

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