CDRH Device Approval Mary S. Pastel, ScD Deputy Director for Radiological Health Office of In Vitro Diagnostics and Radiological Health (OIR) Center for Devices and Radiological Health (CDRH) US Food and Drug Administration (FDA) 14 May 2013 Center for Devices and Radiological Health Promote and protect the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiation-emitting electronic products Slide 2 of 16 1
CDRH 101 FDA regulates manufacturers of the equipment and the equipment itself Premarket requirements Postmarket requirements Requirements for investigational studies LAWS (legally binding requirements) FD&C Act of 1938 ( The Act ), as amended Medical Device Amendments of 1976 REGULATIONS (legally binding requirements) GUIDANCES (recommendations; typically not legally binding) Slide 3 of 16 Device Class and Pre-Market Requirements Device Class Controls FDA Pre-market review process Class I General Controls Most exempt Class II General Controls + Special Controls Class III General Controls + Pre-Market Approval 510(k) clearance PMA approval Slide 4 of 16 2
Class II vs. Class III Class II Special Controls exist to mitigate risk to acceptable levels Technology that is well understood e.g. PET/MR General use devices without specific claims e.g. Most imaging devices Class III Highest level of associated risk new technology for which Special Controls do not exist e.g. breast tomosynthesis Devices that make diagnostic or diseasespecific claims e.g. CADx 5 Drugs and Devices Combination Product - A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) Companion Diagnostic a diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. 6 3
Medical Device Development Tool A scientifically validated clinical outcome assessment, a test used to detect or measure a biomarker, or nonclinical assessment method or model that aids device development and regulatory evaluation. Clinical outcome assessments patient-reported or clinician-reported rating scales Biomarker tests assay for a chemical analyte or medical imaging diagnostic test Nonclinical assessment models in vitro, animal or computational model 7 Medical Device Development Tool (MDDT) Qualification a regulatory conclusion that within a specified context of use, the results of an assessment that uses an MDDT can be relied upon to support device development and regulatory decision-making intended to increase efficiency in the device development process by providing some degree of generalizability for use of MDDT across multiple medical types or clinical disorders 8 4
MDDT Qualification MDDT qualification is independent of premarket clearance/approval A qualification decision considers: 1. Context of use 2. Benefit-risk rationale for the MDDT 3. Strength of evidence supporting the MDDT 9 Clinical uses 1. Diagnosis MDDT Context of Use 2. Patient selection 3. Clinical endpoints Non clinical uses 1. Increase the efficacy of a non-clinical device assessment 10 5
MDDT Qualification represents a new pathway for tools in therapeutic and diagnostic device development and evaluation. Level of validation for qualifying imaging tools may be significantly different than the level of validation for marketing clearance or approval of that imaging tool. 11 Summary CDRH regulates medical devices based on the level of associated risk Class III = PMA Class II = 510(k) Class 1 = no premarket review Use of imaging devices in device development and regulatory evaluation may be independent of premarket clearance/approval of the imaging device 12 6
Thank you! mary.pastel@fda.hhs.gov 7