The FDA/CDRH Perspective in the Regulation of Surgical Mesh

Transcription

1 The FDA/CDRH Perspective in the Regulation of Surgical Mesh David Krause, Ph.D., Branch Chief Plastic & Reconstructive Surgery Branch Division of Surgical, Orthopedic & Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Abdominal Wall Reconstruction Conference June 17 to 19, 2010

2 AWR Conference Presentation Outline Overview of FDA/CDRH FDA/CDRH History Device Classification Overview of Surgical Mesh Regulation Substantial Equivalence References

3 FDA Overview Part of Health and Human Services Administration FDA Com.: Margaret A. Hamburg, MD Made up of Six Centers Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Drug Evaluation and Research (CDER) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) National Center for Toxicological Research (NCTR)

4 CDRH Overview * Office of the Center Director Jeffrey Shuren, M.D., J.D. Director CDRH Ombudsman (Acting) David Buckles Office of Compliance Timothy A. Ulatowski Office of Device Evaluation Christy L. Foreman (Acting) Office of Management Operations Frank Benedetti Office of Surveillance & Biometrics Susan N. Gardner, Ph.D. Office of Communication, Education, & Radiation Programs Lynne L. Rice Office of In Vitro Diagnostic Device Evaluation & Safety Alberto Gutierrez Ph.D. Office of Science & Engineering Laboratories Steve Pollack

5 Important Dates Regarding the Food and Drug Administration President Lincoln appoints Charles M. Wetherill to serve in the new Dept. of Agriculture. The Bureau of Chemistry begins Peter Collier, chief chemist, USDA begins investigating food adulteration. The next year he recommends a national food and drug law The Food and Drugs Act prohibits interstate commerce of misbranded or adulterated foods, drinks and drugs.

6 Important Dates Food and Drug Administration Food, Drug and Cosmetic Act prohibited marketing of adulterated or misbranded medical products. FD&C Act required new drugs to be shown as safe before marketing. FD&C Act defined a drug (Section 201.[321](g)(1)) as: "(B) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and (C) articles (other than food) intended to affect the structure or any function of the body or other animals."

7 Important Dates Food and Drug Administration Kefauver-Harris Drug amendments require demonstration of drug effectiveness before marketing Medical Device Amendments requires the safety and effectiveness of medical devices.

8 Important Dates Center for Devices and Radiological Health Literature review by HEW verifies 10,000 injuries associated with medical devices over 10-year period The Cooper Committee issues a final report recommending inventory and classification of medical devices as a first step in legislating the safety and effectiveness of medical devices All FDA medical device activities are transferred from the Bureau of Drugs to the Office of Assistant Commissioner for Medical Affairs The Bureau of Medical Devices and Diagnostic Products is established Medical Device Amendments

9 Medical Device Amendments The Medical Device Amendments to the FD&C Act are enacted and provide the authority to ensure safe and effective devices through classification, premarket notification, premarket approval and postmarket controls. Section 201.[321](h)(1) of the Food, Drug and Cosmetic Act (i.e., The Medical Device Amendments), defines a device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, which is -

10 Medical Device Amendments (Continued) (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes."

11 CDRH Directive: Promote and Protect the Public Health How is this Done? Benefits Risks

12 CDRH Directive: Promote and Protect the Public Health How is this Done? Getting safe and effective devices to Benefits market as quickly as possible Risks

13 CDRH Directive: Promote and Protect the Public Health How is this Done? Getting safe and effective devices to Benefits market as quickly as possible Risks while ensuring that devices currently on the market remain safe and effective.

14 CDRH Main Tenets Applied Base degree of control on risk Weigh probable benefit vs. risk to determine safety and effectiveness Use valid scientific evidence Consider least burdensome means Provide reasonable assurance

15 Device Classification Approximately 1700 general categories of classified medical devices are included in 16 classification regulations found in 21 CFR Part by the Classification Panels. Class I -- General Controls Class II -- Special Controls Class III -- Premarket Approval

16 Device Classification Class I -- General Controls Prohibit adulterated or misbranded devices. Grant FDA authority to ban certain devices and to restrict sale, distribution or use of devices. Provide for notification of risks and of repair, replacement or refund. Govern Good Manufacturing Practices, records, reports, and inspection. Require domestic device manufacturers, initial distributors (importers) and distributors to register establishments and for manufacturers to list devices.

17 Device Classification Class II -- Special Controls General controls as in Class I. Sufficient information exists to establish special controls (guidance document). May include mandatory performance standards, patient registries, postmarket surveillance, etc.

18 Device Classification Class III -- Premarket Approval General controls as in Class I. Information is insufficient to assure that general controls and special controls provide reasonable assurance of safety and effectiveness. Generally, such devices are represented to be life-sustaining or life-supporting, are implanted in the body, or present an unreasonable potential risk of illness or injury.

19 CDRH Regulation of Surgical Mesh Class II Devices (Special Controls) 21 CFR Surgical Mesh Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

20 Surgical Mesh Intended Use and Indications Intended use: Reinforce soft tissue or bone where weakness exists. Indications: Hernia repair, fascial wall defect repair, use in reconstructive & plastic surgery, protect sutured tendon or ligament repairs, etc.

21 Regulatory Authorities used to Regulate Class II Devices Special Controls Guidance Document with recommendations for data collection and presentation. Used to determine Substantial Equivalence via a Premarket Notification Application based on Section 510(k) of the FD&C Act (21 CFR 807) If Clinical Study Data are needed Investigational Device Exemption (IDE) 21 CFR 812

22 Substantial Equivalence This terminology means that the new device has similar indications for use or intended use and the same technological characteristics as the predicate device If different (but related) technology does not raise different questions regarding safety and effectiveness than the predicate [from 21 CFR (b)].

23 Factors used to Establish Substantial Equivalence Intended Use/Indications Device Description Specification of Device Materials Manufacture and Sterilization Description of the Packaging Product Characterization (biocompatibility, mesh characteristics, product specifications, expiration dating, animal studies, clinical studies Labeling

24 References for Establishing Substantial Equivalence Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh is located here: MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm pdf

25 Additional Reference Device Advice Website: DeviceRegulationandGuidance/ default.htm

26 Contact Information David Krause, Ph.D. Phone: Mail: FDA/CDRH WO Bldg.66, Room 3622 Silver Spring, Maryland 20993

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