Ms. Allis specializes in medical device law. She regularly counsels medical device manufacturers on a wide range of issues, such as product approvals (IDEs, 510(k)s, PMAs), clinical trials, MDRs, recalls, corrections and removals, QSRs, labeling, marketing, and enforcement. She also assists companies in developing regulatory strategies and provides advice on product jurisdictional issues.
Prior to joining the firm, Ms. Allis served as Assistant Chief Counsel for Enforcement at the U.S. Food and Drug Administration. As agency counsel, she worked on matters regarding information disclosure, and enforcement actions such as seizures and injunctions. In addition to working at the Office of the Chief Counsel, Ms. Allis was a lead reviewer in FDA s Center for Devices and Radiological Health (CDRH) from 1995 to 2001, where she evaluated replacement heart valves and ophthalmic implants.
Ms. Allis received a Bachelor of Science in Biomedical Engineering in 1993 and a Master of Science in Biomedical Engineering in 1994 from Tulane University. She graduated cum laude from the American University Washington College of Law in 2003 and is admitted to practice law in the District of Columbia and Maryland.
Articles / Publications
Are Food and Drug Lawyers 'Real' Lawyers?, April 2007
Blog Posts
Are All Health and Wellness Mobile Apps Exempt from FDA Regulatory Requirements?, March 12, 2013
CDRH Issues Joint FDA/FTC Promotion/Advertising Untitled "Email" to On-line Distributors; Unprecedented Approach Warning Possible Criminal Prosecution, March 7, 2013
FTC's Interest in Mobile Apps Intensifies, February 22, 2013
FDA Issues Final Rule on CGMP Requirements for Combination Products; Requirements for "Convenience Kits" Defined, January 24, 2013
Support Appears to be Growing to Delay the Medical Device Tax, December 13, 2012
FDA Issues Draft Guidance Regarding the New Electronic Copy (eCopy) Program for Device Submissions, October 25, 2012
Who Should Regulate Medical Mobile Apps? FDA or Some Other HHS Agency?, October 4, 2012
If You are A Mobile App Developer, Get it Right from the Start, Please!, September 9, 2012
Contract Manufacturers and Contract Sterilizers Must Now Register and List Under New FDA Regulations; Foreign Establishments Also Affected by New Rule, August 8, 2012
GAO Says Device Reviews Are Taking Longer and FDA Says It Is Because Your Submission had Quality Issues, April 4, 2012
Senators Introduce the "Ensuring Safe Medical Devices for Patients" Bill Intended to Strengthen FDA's Postmarket Surveillance of Medical Devices, March 26, 2012
CDRH Issues SOP to Define the Appropriate Management Decision Level for Making Changes to Data Requirements for Premarket Submissions, November 16, 2011
Congress Proposes to Improve the Device Review Process by Amending the Least Burdensome and Conflicts of Interest Provisions in the Act, October 25, 2011
FDA Public Meeting on Mobile Medical Apps and Stand-Alone Clinical Decision Support Software, September 14, 2011
The Feds Challenge Mobile Medical Apps, September 12, 2011
FDA Issues Draft Guidance Document on Mobile Medical Apps, July 24, 2011
ReGen Biologics Sues FDA Over 510(k) Rescission, June 5, 2011
FDA Updates Guidance Document Regarding Changes that Qualify for a 30-Day Notice, May 3, 2011
FDA Issues Warning Letter for Failure to Submit Animal Study Reports in an IDE, April 6, 2011
Minnesota Lawmakers Send Letter to FDA with Concerns About the 510(k) Process, November 30, 2010
House Lawmakers Ask FDA to Delay Implementation of Certain 510(k) Changes, October 13, 2010
CDRH Releases Preliminary Reports with Recommendations for 510(k) Program, August 8, 2010