The Medical Devices Introductory Course 2020

Legislative Framework

• Food, Drug & Cosmetic Ac SEC. 201. [21 U.S.C. 321] covers food, cosmetics, drugs and devices (among other product) regulations: • Medical Device regulations codified in 21 CFR 800-898 (900, 1000-1050) • Drug regulations codified in 21 CFR 200-369 • Biologic regulated under Public Health Service Act (42 U.S.C. 267), codified in 21 CFR 600-680 • Combination Product regulations codified in 21 CFR 3 - 4: • 1976 Medical Device Amendments • 1978 GMPs come into force for medical devices • 1990 Safe Medical Devices Act - substantial equivalence defined, recall requirements strengthened, product jurisdiction • 1996 cGMP requirements revised to form Quality Systems Regulations (QSRs 21 CFR 820) • 1997 FDA Modernization Act (FDAMA) - Class I and II exemptions, pre-IDE meetings, QS changes • 2002 Medical Device User Fee & Modernization Act (MDUFMA) - user fees, 3P inspection, OCP • 2007 MDUFMA II - renewed and expanded user fees program • 2012 MDUFA III and FDA Safety & Innovation Act (FDASIA) - clarifies “least burdensome” standard, device modifications requiring approval, modified de novo process and sets out UDI regulation and new post-market surveillance program, 3P review, Pre-Sub and RTA • 2016 21 st Century Cures Act – real world evidence, combination product innovations, breakthrough devices, least burdensome review, clarifying medical software review • 2017 MDUFA IV – improvements to Pre Sub process, De Novo review, patient engagement, digital health, increased (and new) fees

Food Drug & Cosmetic Act

Regulatory Framework US Food, Drug and Cosmetic Act Codified by 21 CFR 800

801 Labeling 803 Malfunction Reporting 806 Recalls 807 Facility / Device Listing 809 In-Vitro Diagnostics 812 Investigational Exemption 814 Premarket approval 820 Quality system regulation 830 Unique Device Identifier 860

800 801 803 806 807 808 809 810 812 813 814 820 821 822 830 860 861 862 864 866 868 870 872 874 876 878 880 882 884 886 888 890 892 895 898

General Labeling

Medical device reporting

Medical devices; reports of corrections and removals

Establishment registration and device listing for manufacturers and initial importers of devices Exemptions from federal preemption of state and local medical device requirements

In vitro diagnostic products for human use

Medical device recall authority Investigational device exemptions

[reserved]

Premarket approval of medical devices

Quality system regulation

Medical device tracking requirements

Postmarket surveillance Unique device identification

Medical device classification procedures

Procedures for performance standards development Clinical chemistry and clinical toxicology devices

Hematology and pathology devices Immunology and microbiology devices

Anesthesiology devices Cardiovascular devices

Dental devices

Device Classifications

Ear, nose, and throat devices Gastroenterology-urology devices General and plastic surgery devices General hospital and personal use devices

Neurological devices

Obstetrical and gynecological devices

Ophthalmic devices Orthopedic devices

Physical medicine devices

Radiology devices Banned devices

892

Performance standard for electrode lead wires and patient cables