Paths to Market & FDA Product Lifecycle Regulation. Patricia Kaeding Design of Medical Devices University of Minnesota April 14, 2005

Transcription

1 Paths to Market & FDA Product Lifecycle Regulation Patricia Kaeding Design of Medical Devices University of Minnesota April 14, 2005

2 FDA Organization U.S. Food & Drug Administration Headed by a Commissioner of Food & Drugs Part of the U.S. Department of Health & Human Services Five Product-Based Centers within FDA Center for Devices and Radiological Health (CDRH) Office of Regulatory Affairs Central Region Minneapolis District Office

3 FDA Jurisdiction Drugs Biologics Veterinary Products Foods Dietary Supplements Cosmetics Medical Devices Radiation-Emitting products

4 Product Lifecycle Regulation Pre-Clinical Evaluation and Development Good Laboratory Practices (GLPs) Clinical Trials Investigational New Drug (IND) requirements Investigational Device Exemption (IDE) requirements Institutional Review Boards (IRBs)

5 Product Lifecycle Regulation Manufacturing, Processing, Packaging and Repackaging, Labeling and Relabeling, and Distributing Good Manufacturing Practices (GMPs) Quality System Regulation (QSR) Good Tissue Practices (GTP) Registration, Listing, Recordkeeping Imports Exports

6 Product Lifecycle Regulation Content of Label and Labeling Promotion and Advertising Supplements, Amendments, Notice of Modifications Adverse Event Reporting

7 What is a Medical Device A Device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory intended for use in the diagnosis, cure, treatment, prevention of a condition or is intended to affect the structure or function of the body and that does not achieve its purpose via chemical or metabolical processes in or on the body

8 Regulatory Framework for Medical Devices Standard for Devices Reasonable assurance of safety and effectiveness Device Classification Class I: General Controls Class II: Special Controls Class III: Premarket Approval (PMA)

9 Paths to Market: Medical Devices 510(k) Clearance/Pre-Market Notification Must demonstrate that the device is substantially equivalent to a predicate device A predicate device is a pre-1976 device that is not subject to premarket approval 510ks requires significantly less data than premarket approval 90 day decision goal at FDA 510(k) De Novo

10 Paths to Market: Medical Devices Investigational Device Exemption (IDE) Significant risk studies Nonsignificant risk studies Premarket Approval (PMA) Requires clinical data and/or scientific evidence supporting safety and efficacy claim Advisory panel review required for some but not all 320 day decision goal at FDA

11 Paths to Market: PMA v. 510k PMAs provide a high barrier to competitions, but demand significantly more resources and time -- both for the sponsor and FDA -- than 510k s User Fees Authorized by statute for PMAs, 510(k)s, and similar submissions First PMA for small business is free Various deferral, reduction, and exemption provisions

12 Design Controls Required for all Class 3 and Class 2 devices, all computerized devices, and selected Class 1 devices A framework of principles, processes, and procedures for device development Manufacturer must obtain technologyspecific guidance to establish design controls for their devices

13 Design Controls Includes design of the device and associated manufacturing processes Occurs within the context of a quality system plan Covers the entire life cycle of the device

14 Design Control Principles Integrate risk management into design controls Integrate design controls into the company s quality system Senior management responsible for establishing the design development plan

15 Design Control Principles Design and development planning Design input Design output Design review Design verification Design validation Design transfer Design changes Design history file

16 Human Factors End of Life Risk Analysis Design Engineering Biocompatibility Toxicology Mode of Action Hazard Analysis Clinical Sciences Post-Marketing Surveillance Adverse Event Reporting Forensic Engineering Epidemiology Reuse Quality Systems Study Design Statistics Review Sciences Sterility Environment EMC Shock Vibration

17 Combination Products Combination Products are combinations of a drug, device, and/or biologic Examples: drug-eluting cardiovascular stents, human demineralized bone matrix, dental prophylaxis paste with drug components Regulated based on Primary Mode of Action Particular regulatory authorities (drug - device - biologic) applied as appropriate FDA s Office of Combination Products

18 Overview: QSR for Devices FDA s Quality System Regulation enables companies to customize a quality system for device manufacturing Used in conjunction with Current Good Manufacturing Practice (CGMP) requirements for medical devices

19 Key Elements of a QSR Plan Establishes principles Establishes general requirements Defines authority, responsibility and accountability Focuses on making a high quality device, not just on meeting FDA requirements Utilizes prior planning to prevent poor performance

20 Primary Sub-systems Design Controls Material Controls Corrective & Preventive Actions Management Records, Documents, & Change Controls Production & Process Controls Equipment & Facility Controls

21 Contact Information Patricia Kaeding, J.D. Lead Attorney, FDA Practice Godfrey & Kahn, S.C. Madison, Wisconsin Where Great Solutions Are Discovered