M. Elizabeth Bierman

M. Elizabeth Bierman

Morgan Lewis

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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FDA Issues Draft Guidance as Part of Precision Medicine Initiative

The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests. On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more

7/28/2016 - DNA Draft Guidance FDA Genome Project Laboratory Developed Tests National Cancer Moonshot Next Generation Public Comment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New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations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5/25/2016 - Clinical Trials Comment Period Draft Guidance EHR FDA HITECH ONC

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices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

Health Apps and HIPAA: OCR Publishes New Guidance For Health App Developers

OCR’s guidance presents hypothetical scenarios and key questions to help app developers determine when they are subject to HIPAA regulations. On February 11, the Department of Health and Human Services’ Office for Civil...more

3/2/2016 - App Developers Data Collection HHS HIPAA mHealth Mobile Health Apps OCR

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

Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs

The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more

6/22/2015 - Clinical Trials Draft Guidance FDA Investigational Device Exemptions Medical Devices

Trade Agreements Act Compliance Activity Increasing at VA

Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more

4/21/2015 - Country of Origin Federal Supply Schedule (FSS) Manufacturers Medical Devices Pharmaceutical Industry Supply Chain Supply Contracts Trade Agreements Act Veterans Administration

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

FDA Issues Final Guidance on Reprocessing of Medical Devices

The US Food and Drug Administration (FDA) issued a final guidance document on March 12 titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” Although the final guidance was expected...more

3/18/2015 - FDA Final Guidance Medical Devices

Medical Device Update: FDA Releases General Wellness Products and Device Accessories Guidance Documents

Background - On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk...more

1/29/2015 - FDA Medical Device Accessories Medical Devices New Guidance Wearable Technology Wellness Programs

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

FDA Releases Details of New Framework for Laboratory Developed Tests Regulation

FDA sends notice to Congress on LDTs. The U.S. Food and Drug Administration (FDA) has notified Congress that it intends to issue draft guidance to propose a risk-based, phased-in framework for oversight of laboratory...more

8/1/2014 - Draft Guidance FDA Laboratory Developed Tests Manufacturers Medical Devices

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 Warning Letters Signal Narrowing of “Medical Food” Category

Manufacturers seeking to enter the medical food market face increased challenges. The Food and Drug Administration (FDA or the Agency) has issued several Warning Letters to manufacturers of medical foods...more

2/17/2014 - FDA Food Manufacturers Food Safety Healthcare

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

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