Michele L. Buenafe

Michele L. Buenafe

Morgan Lewis

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10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

10/4/2016 - 510(k) RTA Draft Guidance FDA FDASIA Manufacturers Medical Devices Modification Risk Management Section 510

FDA Uses Summer to Issue Numerous Device Guidance Documents

The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more

9/1/2016 - Advisory Committee Clinical Trials CMS Diagnostic Tests Enforcement Actions FDA Final Guidance General Wellness Devices Investigational Device Exemptions Medicaid Medical Devices Medicare Patient-Specific Provider Payments Unique Device Identifiers Validity

FDA Issues Final Guidance for General Wellness Devices

The final guidance confirms FDA’s enforcement discretion for many fitness and wellness technologies but raises issues for certain testing services. On July 29, the US Food and Drug Administration (FDA) announced the...more

8/1/2016 - American Medical Association FDA Final Guidance Medical Devices

FDA Issues Draft Guidance as Part of Precision Medicine Initiative

The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests. On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more

7/28/2016 - DNA Draft Guidance FDA Genome Project Laboratory Developed Tests National Cancer Moonshot Next Generation Public Comment

FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more

6/15/2016 - Comment Period Data Collection FDA FFDCA HIPAA Information Sharing Manufacturers Medical Devices Patient-Specific Privacy Policy

New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more

5/25/2016 - Clinical Trials Comment Period Draft Guidance EHR FDA HITECH ONC

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

5/20/2016 - 3D Printing Comment Period Draft Guidance FDA Life Sciences Manufacturers Medical Devices

FTC Creates Web-Based Tool for Mobile Health App Developers

The new interactive tool highlights the relevant federal regulatory schemes, but the high-level analysis may limit its value to mobile health app developers....more

4/20/2016 - App Developers FDA FTC HIPAA Mobile Health Apps Popular

FDA Active on the Device Front for Q1 2016

Additional guidance documents are expected. The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological...more

4/19/2016 - FDA Life Sciences Medical Devices New Guidance Rulemaking Process Zika

FDA Highlights Human Factors In Three Recently Issued Guidance Documents

The guidance documents relate to human factors testing, data, and clinical considerations. The US Food and Drug Administration (FDA or the Agency) had a busy month in February with respect to human factors, issuing three...more

2/29/2016 - FDA Final Guidance Medical Devices Pharmaceutical Industry

FDA Issues Draft Guidance on ‘Emerging Signals’

New guidance could present liability concerns for device manufacturers. On December 31, 2015, the Food and Drug Administration (FDA or Agency) issued a Draft Guidance for Industry titled “Public Notification of Emerging...more

2/10/2016 - Adverse Events Comment Period Draft Guidance FDA Manufacturers Medical Devices

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

2/3/2016 - Comment Period Cybersecurity Draft Guidance FDA Manufacturers Medical Devices Risk Management

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

7/27/2015 - Biotechnology Digital Health Electronic Medical Records FCC FDA Health Care Providers Health Information Technologies Healthcare Hospitals Marketing Medical Devices Patient-Specific Premarket Approval Applications Software Developers State Regulators Sunshine Act Telemedicine

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

3/26/2015 - Advertising Enforcement Enforcement Actions False Advertising FDA FTC Health Information Technologies Medical Devices mHealth Mobile Apps

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 Industry 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


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 Industry 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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