Jennifer D. Newberger

Attorney in Washington, DC

Jennifer D. Newberger specializes in medical device law, assisting manufacturers on a broad spectrum of US Food and Drug Administration (FDA) matters, including: developing regulatory strategies and preparing product applications; compliance matters, such as MDRs, recalls, and GMPs; advertising and promotion compliance; and regulatory due diligence. Ms. Newberger graduated magna cum laude from the University of Miami School of Law in 2007, earned a Masters of Public Health in International Health from Emory University in 2001, and graduated with honors from Washington University in St. Louis in 1999 with a B.A. in Anthropology. Prior to joining the firm, Ms. Newberger worked as a policy advisor at FDA's Center for Devices and Radiological Health. Previously, Ms. Newberger was an associate in the health care group at the Washington, D.C., office of Arnold & Porter LLP.

Articles / Publications

Thomson Reuters Book: Commercialisation of Health Care, November 4, 2013

Draft Guidance on Medical Device Recalls: Improvements Are Needed, July / August 2013

The US FDA and its Draft Guidance on Medical Device Appeals, April 2013

Summary of CMS Final Rule on Transparency Reporting, February 12, 2013

A Year in Review: CDRH Draft Guidance Documents of 2011, May / June 2012

Proper Reform Is Needed of the Appeals Process at the US Food and Drug Administration's Device Center, January 2012

New Guidance from US FDA May Mean Just One Thing for Medical Device Manufacturers -

More 510(k)s, August 2011

Guidance for Industry Helps FDA (Mostly) Win First Amendment Case on Health Claims, May 2011

Blog Posts

CDRH Releases 2014-2015 Strategic Priorities, February 12, 2014

Sunshine Reporting Registration to Open February 18, February 9, 2014

FDA Issues Final Rule Regarding Pediatric Information Required by FDAAA, January 13, 2014

Booz Allen Hamilton's Priority Recommendations for Device Review Come as No Surprise, December 16, 2013

The Wait is Over: The UDI Rule is Finally Here, September 24, 2013

Recommendations of FDASIA Health IT Workgroup Accepted, September 11, 2013

FDA Issues Final Guidance on Radio Frequency Wireless Technology in Medical Devices, August 18, 2013

The Mystery of the Missing MDR Notice, July 21, 2013

All Device Manufacturers Must Report!, July 14, 2013

The Hackers are Coming!, June 19, 2013

CDRH Issues Draft Guidance for IDE and Pre-IDE Processes, June 18, 2013

CDRH Issues Final Appeals Guidance, Q&A About FDASIA Appeals Process, May 20, 2013

FDA Announces Public Meeting Regarding Device Modifications, May 14, 2013

FDA Proposes to Harmonize Medical Device Labeling, April 23, 2013

CDRH Working to Update Appeals Guidance for Consistency with FDASIA, April 17, 2013

FDA Issues Proposed Rule Affecting Acceptance of Data from Medical Device Clinical Studies, February 25, 2013

FDA Issues Draft Guidance, Proposed Rule Regarding Submission of Information on Pediatric Use of Medical Devices, February 24, 2013

CMS Belatedly Issues Sunshine Rule; HP&M Promptly Issues Summary, February 6, 2013

FDA Finalizes Guidance on Humanitarian Use Device Designations, January 29, 2013

CDRH Releases Three Final Guidance Documents, January 3, 2013

Your Dog as a Medical Device?, December 26, 2012

CDRH Issues Report on Improvements in Device Review, December 3, 2012

FDA Seeks Comments on Custom Devices, November 20, 2012

FDA Amends UDI Proposed Rule to Comply with FDASIA Requirements, November 19, 2012

CDRH Reorganizes its Office of Device Evaluation, November 7, 2012

GAO Report on Potential Information Security Risks for Certain Devices, October 1, 2012

Is it a Drug or Device? Court Requires FDA to Explain Itself, September 26, 2012

Insight into FDA's Implementation of FDASIA for Devices, September 25, 2012

CDRH Seeks to Enhance Postmarket Surveillance Systems, September 11, 2012

A Solution in Search of a Problem, Part II, August 16, 2012

FDA Issues New Refuse to Accept Policy for 510(k)s, August 13, 2012

FDA Divides Filing Criteria for PMAs into "Acceptance Criteria" and "Filing Criteria", July 31, 2012

FDA Issues Draft Guidance Expanding Pre-IDE to Pre-Submission Program, July 22, 2012

OIG Releases Report Regarding Scientific Disagreements at CDRH, June 11, 2012

House Bill Introduced to Include Medical Devices in the Postmarket Risk Analysis and Identification System, May 10, 2012

Congress Introduces the PATIENTS' FDA Act to Increase Transparency, Efficiency, and Predictability, April 20, 2012

CDRH Finalizes Guidance on Benefit-Risk Determinations, March 28, 2012

FDA Issues Draft MDUFA Performance Goals and Procedures, March 22, 2012

FDA Denies Washington Legal Foundation Citizen Petition, February 27, 2012

Reps. Rogers and Markey Introduce Bill to Implement Withdrawn Pediatric Medical Device Rule, February 10, 2012

Senators Casey and McCain Introduce Bill to Streamline De Novo Process and Reclassify Preamendment Devices, February 6, 2012

A Solution in Search of a Problem: Safety of Untested and New Devices Act of 2012, February 1, 2012

CDRH Issues its Strategic Priorities for 2012, January 29, 2012

FDA Issues Draft Guidance on Medical Device Appeals Processes, January 5, 2012

CDRH Issues Draft Guidance on Substantial Equivalence Determinations, December 29, 2011

GAO Reports on Approval of Pediatric Medical Devices, December 22, 2011

Medical Device Patient Safety Act Introduced in the Senate; Bill Would Allow for Recall Tracking and Conditional Clearances, December 18, 2011

Senator Brown Proposes Modifications to the De Novo Process, December 6, 2011

Senators Propose Legislation to Allow for Profits on Devices for Rare Diseases, Lifting Limitations on Experts to Serve on Advisory Panels, November 17, 2011

FDA Issues Report on Medical Device Quality, November 4, 2011

Proposed Statutory Change Could Make de novo Process More Appealing, October 19, 2011

FDA Issues Draft Guidance Proposing to Streamline the de novo Classification Process, October 2, 2011

FDA Releases Two Medical Device Draft Guidances, August 16, 2011

IOM Recommends Replacing 510(k) Clearance Process "As Soon As Reasonably Possible", July 29, 2011

FDA Issues Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", July 26, 2011

Tobacco Product Retailers and Marketers Take Note: FDA Announces the Availability of More Guidance Documents, April 27, 2011

To Disclaim or Ban Outright - "Credible Evidence" for Health Claims, April 17, 2011

Failure to Launch: OIG's Recommendations to HHS, March 20, 2011

Speaking Engagements

FDLI Introduction to Medical Device Law & Regulations, April 3 - 4, 2013
Registration and Listing

FDLI: Introduction to Medical Device Law and Regulation, March 12 - 13, 2012
Clinical Investigations

(202) 737-4292
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Areas of Law

  • FDA and Healthcare
  • Food and Drug Regulation
  • Food, Drug and Cosmetic Law

 

Experience & Credentials

Position

Associate

Admission Details

Admitted in 2007, District of Columbia

Law School Attended

University of Miami School of Law
Class of 2007
J.D.
magna cum laude

University Attended

Washington University, St. Louis
Class of 1999
B.A.
Anthropology, with honors

Emory University
Class of 2001
M.P.H.
International Health

Community Contributions

Contact Information

Phone

(202) 737-4292

Email

Send email to Jennifer D. Newberger


Office Information
Jennifer D. Newberger
Associate
 700 Thirteenth Street, N.W., Suite 1200,
Washington, DC 20005-5929

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Hyman, Phelps & McNamara, P.C. (Washington, District of Columbia)

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