_A Regulatory Strategy helps researchers ensure that their products are safe and efficacious according to the legal and regulatory requirements of biomedical product development. Click here for an overview of device regulations in the United States.
CTIP’s steering committee and advisory board include regulatory experts that can help you develop a regulatory strategy and determine which pathway to take. CTIP can also host educational seminars and workshops on this topic. For more information, contact us at firstname.lastname@example.org or call 323.361.8368.
CTIP Regulatory Resources
USC Regulatory Science Program - The Regulatory Science Consulting Center provides advice and services to faculty with new grants, start-up companies with interesting products, or others who need regulatory help. Regulatory services include strategic planning from design to market; identifying the regulatory requirements for clinical grants and providing advice and services for compliance; and assisting clients in regulatory submissions, clinical trial management, manufacturing compliance, quality system implementation, and other regulatory requirements. Directed by Dr. Frances Richmond (CTIP Steering Committee)
USC's International Center for Regulatory Science - The International Center helps product developers understand the opportunities and constraints presented by regulatory systems in other constituencies, and advising on clinical opportunities internationally. Directed by Dr. Frances Richmond (CTIP Steering Committee)
- FDA Classification Database – A FDA search page that enables a user to classify a device based on the device name, review panel, regulation number, product code, submission type, third-party eligibility, and device class.
- Device Classification Panels – This FDA website lists the medical specialties used to review medical devices. Selecting the most likely specialist that would use the product under development enables the user to see the seven-digit device classifications categorized within the specialty.
- CDRH Super Search – Allows individuals to search through multiple FDA databases, including the device listing database, 510(k) and PMA databases, Products Classification database, the Code of Federal Regulation (CFR) Title 21 database, and the Clinical Laboratory Improvement Amendments (CLIA) database. For device classification purposes, the first four databases listed above will prove most useful.
Regulatory Pathway Resources
- FDA Device Advice – CDRH’s self-service site for obtaining information concerning medical devices and the application/submission processes.
- CDRH Guidance Documents – Documents prepared for CDRH staff, regulated industry, and the public that relate to the processing, content, and evaluation of regulatory submissions, design, production, manufacturing, and testing of regulated products, as well as CDRH inspection and enforcement procedures.
- CDER and CBER Guidance Documents – Guidance documents (as defined above) for investigational new drugs.
- FDA’s Clinical Trials Guidance Documents.
Other Regulatory Resources
- European Commission Medical Device Sector Legislation – Overview of the European directives that govern medical devices.
- MHRA Medical Device Directive – Additional information about regulatory processes in the EU.
- Regulatory Affairs Professional Society – An online source for tools, coursework, guidance, and articles on regulatory subjects.
- Professional Articles – Articles in leading professional journals (e.g., Kaplan et al., “Medical Device Development: From Prototype to Regulatory Approval,” Circulation, 2004, pp. 3068-3072) can provide valuable information and timely insights into the dynamic regulatory process.
- Loeb, G.E. and Richmond, F.J.R. Making Design Controls Useful for Research and Development. Medical Device and Diagnostic Industry 25(4):63-68, April, 2003, http://www.mddionline.com/article/making-design-controls-useful-rd