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
The US FDA and its Draft Guidance on Medical Device Appeals, April 2013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A Year in Review: CDRH Draft Guidance Documents of 2011, May / June 2012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
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FDA Issues Draft Guidance, Proposed Rule Regarding Submission of Information on Pediatric Use of Medical Devices, February 24, 2013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
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