FDA Regulation and Risk Assessment of Medical Devices
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1 FDA Regulation and Risk Assessment of Medical Devices IOM Workshop on the Certification of Personal Protective Technologies April 13, 2010 Markham C. Luke, MD PhD Deputy Office Director & Chief Medical Officer Office of Device Evaluation, CDRH, FDA 1
2 Office of Device Evaluation Who are we? 380+ dedicated public health officials Engineers, scientists, clinicians, and support staff Organized into seven divisions: five by clinical speciality, and two for support 2
3 PROGRAM OPERATIONS STAFF (POS) DIRECTOR: ROBERT R. GATLING ( ) PMA SECTION: NICOLE WOLANSKI IDE/HDE SECTION: SHEILA BROWN 510(K) SECTION: HEATHER S ROSECRANS OFFICE OF THE DIRECTOR ACTING DIRECTOR: CHRISTY FOREMAN ( ) DEPUTY DIRECTOR, CLINICAL: MARKHAM C. LUKE, M.D., Ph.D. DEPUTY DIRECTOR, ENGINEERING & SCIENCE REVIEW: vacantt DEPUTY DIRECTOR, PREMARKET PROGRAM MGMT: BARBARA ZIMMERMAN ADVISORY PANEL STAFF COORDINATOR GERETTA WOOD PROGRAM MANAGEMENT OFFICE (PMO) DIRECTOR: KATHRYN K. APPLER (6-5560) DEPUTY DIRECTOR: LESA DOWTIN (6-5560) DIVISION OF CARDIOVASCULAR DEVICES (DCD) DIRECTOR: BRAM D. ZUCKERMAN, M.D. ( ) DEPUTY DIRECTOR I: DONNA LOCHNER (6-7000) DEPUTY DIRECTOR II: WILLIAM MCFARLAND (6-7000) PACING, DEFIBRILLATOR, AND LEADS BRANCH: MITCHELL SHEIN (6-6930) CARDIAC ELECTROPHYSIOLOGY AND MONITORING BRANCH: ELIAS MALLIS (6-5630) INTERVENTIONAL CARDIOLOGY DEVICES BRANCH: *HEATHER AGLER (6-5570) CIRCULATORY SUPPORT & PROSTHETIC DEVICES BRANCH: MATTHEW HILLEBRENNER (6-6940) PERIPHERAL VASCULAR DEVICES BRANCH: KENNETH CAVANAUGH, Ph.D. (6-6950) DIVISION OF REPRODUCTIVE, ABDOMINAL, AND RADIOLOGICAL DEVICES (DRARD) DIRECTOR: *JANINE MORRIS ( ) CLINICAL DEPUTY DIRECTOR: HERBERT P. LERNER, M.D. (6-6650) SCIENTIFIC DEPUTY DIRECTOR: NICOLE WOLANSKI,(6-6650) OBSTETRICS/GYNECOLOGY DEVICES BRANCH: COLIN POLLARD (6-6650) UROLOGY & LITHOTRIPSY DEVICES BRANCH: *HERBERT LERNER, M.D. (6-6630) GASTROENTEROLOGY & RENAL DEVICES BRANCH: CAROLYN NEULAND, Ph.D. (6-5590) DIVISION OF OPHTHALMIC, NEUROLOGICAL, AND EAR, NOSE, AND THROAT DEVICES (DONED) DIRECTOR: MALVINA EYDELMAN, M.D. ( ) SCIENTIFIC DEPUTY DIRECTOR: KESIA ALEXANDER, Ph.D. (6-5620) CLINICAL DEPUTY DIRECTOR: ERIC MANN, M.D., Ph.D. (6-5620) ASSOCIATE DIRECTOR: DEBORAH FALLS (6-5620) NEURODIAGNOSTIC AND NEUROTHERAPEUTIC DEVICES BRANCH: QUYNH HOANG (6-6610) OPHTHALMIC LASERS, NEUROMUSCULAR STIMULATORS, AND DIAGNOSTICS BRANCH: *DEXIU SHI (6-6620) INTRAOCULAR, CORNEA AND NEUROMATERIALS BRANCH: *DENISE HAMPTON, Ph.D. (6-6860) EAR, NOSE, & THROAT DEVICES BRANCH: SRINIVAS NANDKUMAR, Ph.D. (6-6890) *Acting DIV. OF SURGICAL, ORTHOPEDIC, AND RESTORATIVE DEVICES (DSORD) DIRECTOR: MARK MELKERSON ( ) DEPUTY DIRECTOR I: BARBARA BUCH, M.D. (6-5650) DEPUTY DIRECTOR II: PETER RUMM, M.D. (6-5650) PLASTIC & RECONSTRUCTIVE SURGERY DEVICES BRANCH: DAVID KRAUSE, Ph.D. (6-6970) GENERAL SURGERY DEVICES BRANCH: NEIL OGDEN (6-6930) ORTHOPEDIC JOINT DEVICES BRANCH: JONETTE FOY, Ph.D. (6-6910) ORTHOPEDIC SPINE DEVICES BRANCH: *ERICA TAKAI, Ph.D. (6-6920) RESTORATIVE DEVICES BRANCH: LAURENCE COYNE, Ph.D. (6-6900) DIVISION OF ANESTHESIOLOGY, GENERAL HOSPITAL, INFECTION CONTROL, AND DENTAL DEVICES (DAGID) DIRECTOR: ANTHONY D. WATSON (6-5580) DEPUTY DIRECTOR: *SUSAN RUNNER, D.D.S. ( ) ASSOCIATE DIRECTOR FOR OPERATIONS: *KWAME ULMER (6-5580) ANESTHESIOLOGY & RESPIRATORY DEVICES BRANCH: LESTER SCHULTHEIS, MD (6-5580) GENERAL HOSPITAL DEVICES BRANCH: *CHARLES ZIMLIKI, Ph.D. (6-5580) INFECTION CONTROL DEVICES BRANCH: *LIZ CLAVERIE,. (6-5580) DENTAL DEVICES BRANCH: M. SUSAN RUNNER, D.D.S. (6-5580) 3
4 IOM: What current process is used at FDA to assess the level of risk of a medical device and make determinations about the device class and whether the 510(k) process is required? 4
5 Risk-Based Paradigm The law gives us the flexibility to calibrate our regulatory approach to the level of potential risk posed by new products 5
6 Risk-Based Classification of Medical Devices Class I: simple, low risk devices Subject to General Controls Registration and Listing, Quality System, Adverse Event Reporting, Prohibitions against misbranding and adulteration Most exempt from premarket review 6
![Premarket Notification [510(k)] Regulatory standard is Substantial](/docs-images/77/75300031/images/7-2.jpg "Equivalence Most cleared based on preclinical and animal testing (10%")
7 Risk-Based Classification of Medical Devices Class II: more complex, higher risk Subject to General Controls PLUS Special Controls Most require Premarket Notification [510(k)] Regulatory standard is Substantial Equivalence Most cleared based on preclinical and animal testing (10% require clinical) 7
8 Substantial Equivalence (SE) 510(k) submissions compare new devices to predicate marketed devices A decision flowsheet results in a binary determination of SE vs. NSE Indication and Intended Clinical Effect/Use Technological Characteristics (Design/Material) New types of Safety/Effectiveness Concerns Performance Data
![Application [PMA] Regulatory standard is reasonable assurance](/docs-images/77/75300031/images/9-2.jpg "of safety and effectiveness May include post-approval study")
9 Risk-Based Classification of Medical Devices Class III: most complex, highest risk Bench Animal - Clinical Premarket Application [PMA] Regulatory standard is reasonable assurance of safety and effectiveness May include post-approval study requirements 9
10 Humanitarian Device Exemptions Devices targeted at fewer than 4000 patients per year Must demonstrate safety and probable benefit outweighs probable risk 10
11 IDE (Investigational Devices Exemption) Allows investigational devices to be used in clinical studies to support PMA, 510(k) Requirements for informed consent, labeling, monitoring, records/reports Requires approval by Institutional Review Board (IRB) and, for significant risk devices, FDA 30-day review period 11
12 Combination Products Include device/drug and device/biologic products that are: physically linked; or separately packaged together (e.g., drug and device products); or packaged separately but required to be used together. Raise unique regulatory and scientific issues 12
13 IOM: Are medical device determinations predominantly based on risk to the patient or the healthcare worker or both? 13
14 Medical Device Risk to Patient and Provider Risk is assessed for medical devices in the setting of risk vs. benefit Risk to the healthcare provider is considered during the review of a medical product and steps are taken to minimize risk. Examples: Eyewear protection for lasers Universal precautions Latex and other allergenicity concerns 14
15 IOM: What are the current post-marketing surveillance efforts for device safety? 15
16 Medical Device Post-marketing Surveillance MedWatch FDA Safety Information and Adverse Event Reporting Program MedSun Medical Product Safety Network MAUDE Manufacturer and User Facility Device Experience Quality Systems Post-approval Studies 16
17 IOM: Are any medical devices required to go through thirdparty testing prior to FDA clearance? 17
18 Testing Prior to Marketing Non-clinical testing Bench testing Non-clinical models Clinical testing Requirements can be described in regulations, guidance or in meetings with FDA Standards and certifications 18
19 Reliance on third-party certification FDA may allow medical device labeling to include description of certification by a third party. An example is for N95 respirators FDA describes in the 510(k) Guidance for Surgical Masks that labeling can include mention of N95 certification by NIOSH if the device has such certification. 19
20 Standards and conformity FDA shall accept a declaration of conformity unless: the data or information submitted to support the declaration does not demonstrate that the device is in conformance with the standard; or the standard identified in the declaration is not applicable to device under review. 20
21 IOM: How are devices (e.g. gowns) regulated that are sold without having gone through the FDA medical device clearance process? 21
22 Regulation of Exempt Devices Most Class I devices are exempt from notification General Controls Prohibition against adulterated or misbranded devices GMPs, registration of manufacturing facilities Listing of devices types Record keeping Repair, replacement, refund 22
23 Regulation of Exempt Devices Post-market surveillance Evaluation of claims made Manufacturing defects Adverse event reports Compliance actions 23
24 FDA and Risk-based Device Regulation Take Aways Protective medical device equipment related to the treatment, diagnosis, prevention or mitigation of a disease are regulated by FDA via a risk-based paradigm. Risk-based regulation encompasses premarket and post-market controls. 24
25 Questions? 25
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