M. Elizabeth Bierman

M. Elizabeth Bierman

Morgan Lewis

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FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

2/14/2017 - Cybersecurity FDA Labeling Life Sciences Manufacturers Medical Devices Obama Administration

FDA Issues Final Guidance on Postmarket Cybersecurity

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

1/10/2017 - Cybersecurity Data Breach FDA Final Guidance Life Sciences Manufacturers Medical Devices

FDA Issues Final Guidance on “Emerging Signals”

Guidance addresses industry concerns about premature public notifications. On December 14, 2015, the FDA issued a final guidance titled “Public Notification of Emerging Postmarket Medical Device Signals” (Final...more

12/21/2016 - FDA Life Sciences Premature Claims

21st Century Cures Act and Medical Device Regulatory Pathways

These seven key provisions will affect the premarket requirements for medical devices. The US Senate passed the 21st Century Cures Act on December 7, and President Barack Obama is expected to sign the bill into law....more

12/9/2016 - 21st Century Cures Initiative EAP FDA Life Sciences Medical Devices

The 21st Century Cures Act and Its Effect on Digital Health

New legislation includes a broad regulatory exemption for medical software. On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it. This new...more

12/8/2016 - 21st Century Cures Initiative Digital Health FDA Life Sciences Software

Top Takeaways from FDA Draft Guidance on Software as a Medical Device

FDA’s proposed adoption of an IMDRF document raises questions. On October 14, the US Food and Drug Administration (FDA or the Agency) releaseda new draft guidance document, Software as a Medical Device (SaMD): Clinical...more

11/14/2016 - Draft Guidance FDA Life Sciences Medical Devices Software

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens.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

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

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