More than 20 years in the FDA medical device space. Former FDA reviewer and agency counsel, engineer, lawyer. Crossing all medical specialties. Helping start-ups and established companies. We know what it takes to navigate the regulatory process.
Contact us and let's discuss how we can assist with your FDA regulatory inquiry. Whether it's medical device approvals, 510(k) submissions/clearances, product jurisdiction determinations, combination products, device classification, pre-clinical/bench studies, postmarket compliance, reporting requirements, product labeling, medical device promotion and advertising, or enforcement actions.
Commitment to detail. Forward-looking to client's goals. Strategy. Unique perspective and experience on the regulatory process. Helping companies navigate through the multitude of FDA regulations, rules, policies, guidance documents, and undocumented practices that can significantly affect an application pending at FDA.
The Allis Law Firm specializes in medical device law and regulation. We assist medical device companies during all stages of a product lifecycle, providing informed and seasoned guidance based on years of experience in private practice and working for the U.S. Food and Drug Administration (FDA). Our practice crosses all medical specialt
The Allis Law Firm specializes in medical device law and regulation. We assist medical device companies during all stages of a product lifecycle, providing informed and seasoned guidance based on years of experience in private practice and working for the U.S. Food and Drug Administration (FDA). Our practice crosses all medical specialties. Some of our services include:
The process of applying for and obtaining FDA's approval or clearance for a new medical product can be complicated and vulnerable to numerous and costly delays. It is critical to have a regulatory strategy in place from the beginning, and the flexibility to adapt as the product proceeds through development and pre-clinical and clinical
The process of applying for and obtaining FDA's approval or clearance for a new medical product can be complicated and vulnerable to numerous and costly delays. It is critical to have a regulatory strategy in place from the beginning, and the flexibility to adapt as the product proceeds through development and pre-clinical and clinical testing. Quite often, a company will make a seemingly minor mistake when first presenting the product to FDA in an application or in interactions with FDA staff -- a mistake that can be costly in both time and money, and which sometimes leads the FDA review staff to select an improper regulatory pathway for the product.
In addition to helping companies navigate through the multitude of FDA regulations, rules, policies, guidance documents, and undocumented practices that can significantly affect an application pending at FDA, we also assist companies with post-market regulatory requirements, including adverse event reporting and quality system/good manufa
In addition to helping companies navigate through the multitude of FDA regulations, rules, policies, guidance documents, and undocumented practices that can significantly affect an application pending at FDA, we also assist companies with post-market regulatory requirements, including adverse event reporting and quality system/good manufacturing practice (QSR/GMP) matters and responses to Warning Letters and Form FDA 483s, as well as matters related to product labeling, advertising and promotional activities .
Ms. Allis is a Member and Founder of The Allis Law Firm, PLLC. She has over 20 years of experience on matters related to the U.S. Food and Drug Administration (FDA) regulation of medical devices. She has focused her career on all aspects related to the premarket and postmarket regulation of medical devices, including issues involving the design, testing, manufacturing, advertising, and marketing of medical devices in the U.S. Ms. Allis has experience on a wide range of regulatory matters, including device approval/clearance, product jurisdiction, device classification, pre-clinical/bench studies, human clinical trials, postmarket compliance, mobile apps, and medical device labeling, promotion, and advertising. Her device experience crosses all medical specialties.
Ms. Allis began her career as a biomedical engineer at the Office of Device Evaluation (ODE) in FDA's Center for Devices and Radiological Health (CDRH), which is the body responsible for the approval and clearance of new medical devices entering the U.S. market. Ms. Allis served as a lead scientific reviewer responsible for shepherding 510(k), PMA, and IDE applications through the regulatory review process and, ultimately, making the initial determination on whether to approve or clear a medical device for market. As an FDA reviewer, Ms. Allis gained valuable insight into the scientific issues and concerns driving FDA's policies and practices, which provides first-hand experience within the ranks of FDA's review staff. While working at the FDA as a reviewer, Ms. Allis was responsible primarily for the review and approval/clearance of ophthalmic devices and later moved on to serve as a lead reviewer for prosthetic heart valves.
Ms. Allis subsequently left FDA's scientific review staff to attend law school in Washington, D.C., and then returned to FDA as an attorney in the agency's Office of the Chief Counsel in Maryland. As agency counsel, she worked on matters regarding information disclosure (Freedom of Information Act (FOIA)), and on enforcement actions such as seizures and injunctions.
Ms. Allis left government service for private practice. Prior to starting her own practice, Ms. Allis worked for a law firm in Washington, D.C. She assists national and international clients. Some of these matters have involved assisting small companies and multi-million dollar global entities successfully bring FDA inspections and Warning Letters to closure. Ms. Allis also assists Fortune 500 companies in developing marketing claims and strategies, and has assisted countless manufacturers in obtaining clearances and approvals.