1	Software Regulation Overview The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Presented by James V. Callaghan
2	Disclaimer This presentation represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the view expressed
3	How Is Software Regulated? We first determine if the software is a medical device or associated with a medical device Then we classify the software The software is regulated according to the classification of the Software
4	"Medical Device - 201(h)" Medical Device - 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 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 intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's 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 any of its primary intended purposes."
5	Types of Medical Device software Software Controlled Medical Devices Stand Alone Medical Software Accessory or Component Software to Medical Devices
6	Software Controlled Medical Devices Diagnostic Instrumentation Laboratory Information Systems Laboratory Automation Systems Drug Delivery Systems Any medical device controlled by software
7	Stand Alone Medical Software Software itself is a medical device Algorithms to diagnose Algorithms for therapeutic recommendation Quality control Others….
8	Accessory or Component software to medical devices Hospital Information Systems Data Management Systems Software integrating two or more devices Communication Systems
9	General Purpose Article Software application that is promoted for general use and not for any medical use but can be used in association with a medical use, such as: Networks Microsoft operating systems Databases, spreadsheets…. The software manufacturers (Microsoft) are not subject to FDA regulations, however the medical device manufacturer should follow Off the Shelf (OTS) Software Guidance
10	Classification Classification is based on indications for use - May 28, 1976 Classifications in 21CFR Parts 862, 864…to 892 Class I - general controls – GMP, Software QSR – Design Controls, 510(k) exempt Class II - subject to QSR special controls 510(k) – standards, guidance, labeling…. Class III and unclassified medical devices Premarket Approval (PMA)….
11	Classification Devices are classified based on those that were in commercial distribution prior to May 28, 1976 (predicate device) The 510(k) process establishes safety and effectiveness based on being substantially equivalent to a predicate device and special controls The PMA process establishes safety and effectiveness for class III and unclassified medical device - not equivalence to a predicate: clinical studies, inspection of manufacturing site, advisory panel input, post approval requirements, annual reports….
12	Class I (i) general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, or (ii) there is insufficient information from which to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but the device is not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness of injury.
13	Class II A device is in class II if general controls alone are insufficient to provide reasonable assurance of its safety and effectiveness and there is sufficient information to establish special controls …. in accordance with section 510(k) of the act recommendations, and other appropriate actions as the Commissioner deems necessary to provide such assurance. For a device that is purported or represented to be for use in supporting or sustaining human life, the Commissioner shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance
14	Class III A device is in class III if insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.
15	Classification Classification is based on indications for use - May 28, 1976, Classifications in 21CFR Parts 862, 864…to 892 Class I - general controls – GMP, Software QSR – Design Controls, 510(k) exempt, Class II - subject to QSR special controls 510(k) – standards, guidance, labeling…. Class III and unclassified medical devices Premarket Approval (PMA)….
16	Sec. 862.9, 864.9 to…892.9 Limitations of exemptions from section 510(k) Class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or
17	Sec. 862.9, 864.9 to…892.9 Limitations of exemptions from section 510(k) (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in 812.3(k) of this chapter; and (9) For near patient testing (point of care).
18	Classification Classification is based on indications for use - May 28, 1976, Classifications in 21CFR Parts 862, 864…to 892 Class I - general controls – GMP, Software QSR – Design Controls, 510(k) exempt, subject to limitations Class II - subject to QSR special controls 510(k) – standards, guidance, labeling…. Class III and unclassified medical devices Premarket Approval (PMA)….
19	Unclassified Medical Device There is no predicate device to base classification Automatically Class III Low risk unclassified devices De novo candidate 510(k) NSE based on no predicate Special controls guidance New 510(k) cleared as Class II with own regulation
20	Software Regulation for Clinical Laboratory Automation
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22	Regulatory Requirements Based on Classification Premarket requirements All subject to GMP and for software Design controls under 21 CFR 820 QSR Class I are exempt from 510(k) subject 862.9, 864.9 …892.9 (limitations) Class II require 510(k) submissions - standards, guidance, labeling…. Class III and unclassified devices require PMA submissions Postmarket requirements QSR, MDR, Misbranding and Adulteration Recalls…
23	Classification HELP Section 513(g) of the Act
24	Section 513(g) of the Act Within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this Act, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this Act applicable to the device
25	Mailing Address: 513(G) Coordinator Office of Device Evaluation Center for Devices and Radiological Health c/o Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, MD 20850
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