Regulatory Basics��

Reading: Chapter 4.2 �

Regulatory Pathways�•  Drugs, Devices & Biologics must be regulated to ensure

safety and efficacy �•  In the US, regulated by FDA �

Center for Biologics Eval &

Research

Center for Drug Eval & Research

Center for Food Safety & Applied

Nutrition

National Center for Toxicology

Research

Office of Combination Products

Office of Combination Products�•  created in 2002 �

•  main duties include: �- assigning combination product reviews to a center and coordinating timely premarket reviews involving >1 center�

- assignment based on “most important therapeutic action of a combination product”�

- ensure consistency and appropriateness of combination-product postmarket regulation�

- established a framework for selecting the lead review center for products for which a primary action cannot be determined. �

"An instrument, apparatus, implement, machine, contrivance, article, including a component or part, or accessory which is ��….intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, ��and which does not achieve any of its primary intended purpose through chemical action within or on the body of a man or other animal and which is not dependent on being metabolized for the achievement of it primary intended purpose.”��

" "à If it isn’t a drug or biologic, it is a device. �

Definition of a Device �

510(k) Designation�510(k) is a pre-market submission to demonstrate that a device is substantially equivalent to a legally marketed device that is not subject to pre-market approval (PMA)��What is Substantial Equivalence? �•  the new device is at least as safe and effective as the predicate�

•  it has the same intended use as the predicate�

•  AND has the same technological characteristics as the predicate��•  OR has different technological characteristics and info submitted to FDA �

-  does not raise new questions of safety and effectiveness�- demonstrates as safe and effective as the predicate�

Biologic or Drug: �$50 – 300 million �

Device PMA: �$50 – 200 million �

1 �

510(k): �$5 – 20 million �

Years�

Investigational Device Exemption (IDE) or Investigational New Drug (IND) allows a clinical study to support an FDA submission ��

PLA: Product License Application �NDA: New Drug Application �BLA: Biologic License Application �Exclusivity to market a compound for a particular purpose�2 � 3 �0 �

1 � 2 � 3 � 5 � 6 � 7 �4 � 8 �

1 � 2 � 3 �0 � 5 �4 �

�Ratcliffe. In: TE in Clinical Practice, Sandell & Grodzinsky, Eds., AAOS, 2004 �

Due to complex nature of many new medical treatments, uncertainty in the regulatory requirements exists��Variability in assignment to primary FDA center ��Assigned on case-by-case basis����

Regulatory Challenges�

Video Briefs: � �Understanding the FDA ��510(k) vs. PMA Regulatory Strategy�