Introduction to US FDA Regulatory Framework NSF SB SF SBIR Pha Phase I I Grant ntee Pr Program Arlin lingto ton, V , VA Septem ember 20, 0, 2 2017 17 Dinesh esh V V Patwar ardhan an P Ph.D.
Agenda • FDA Organization • Introduction to Centers within FDA • Combination Products • Medical Devices Amendments • Benefit-Risk Paradigm • Quality System (QSR) • Resources & Initiatives – Guidance Documents – Software as a Medical Device – Medical Device Development Tools (MDDT) 2
FDA in news FDA touches 20-25 % of US economy 3
FDA Organizational Chart Departm tment o of Health th an and H Human S Ser ervice ces Center f r for V Veteri rinary ry Center fo for F Food S Safe fety Medicine ( e (CVM) M) And A Applied N Nutrition on (CFSAN AN) Food a d and Drug A g Admin ministratio ion Cent nter f for B Biol olog ogics Nationa onal C Cent nter f for Evalua uation on and R Research Toxico cological cal R Resear earch (CBER) R) Cente enter f for or T Tob obacco co Prod oducts ts (C (CTP) Cen ente ter for Devic vices an and d Cent nter f for D Drug ug E Evalua uation on Radio adiolo logic ical Healt Health and R Resear earch ( (CDER) (CDR CDRH) 4
Legislative History 1902 Biologics Control Act 1906 Food & Drug Act (F&D Act) 1938 Federal, Food, Drug, and Cosmetic Act (FD&C Act) 1968 Radiation Control for Health & Safety Act (RCHSA) 1976 Medical Device Amendment of 1976 1988 Clinical Laboratory Improvement Amendments (CLIA) 1990 Safe Medical Devices Act (SMDA) 1992 Mammography Quality Standards Act (MQSA) 1992 Medical Device Amendments 1997 Food & Drug Administration Modernization Act (FDAMA) 2002 Medical Device User Fee and Modernization Act (MDUFMA) 2005 Medical Device User Fee Stabilization Act (MDUFSA) 2007 Food and Drug Administration Amendments Act of 2007 (FDAAA) 2012 FDA Safety and Innovation Act (FDASIA) 2017 FDA Reauthorization Act (FDARA) 2017 5
Medical Device Defined • Sect ection 201( 201(h) of the FD&C Act defines a medical device as: (…in part…) • A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article • ..intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man…. • ..intended to affect the structure or any function of the body,.. • and does not not achieve its principal intended purpose by chem emical cal a action on or by being metaboliz lized. • As As simple as as a a tong tongue d depressor or or a a the thermometer • As complex a as roboti otic s c surger ery d devices ces 6
Definition (regs) • Drug (in part)…...A substance recognized by an official pharmacopoeia or formulary. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body….. [FD&C Act, sec. 201(g)(1)] • Cosmetic (in part) ….articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance….[FD&C Act, sec. 201(i)]. And so on… 7
Combination Products Definition • 21 CFR 3.2(e): Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products • Lead center is based on “ primary mode of action ” (PMOA) • Office of Combination Products 8
Combination Products • Device coated or impregnated with a drug or biologic • Drug-eluting stent; pacing lead with steroid-coated tip; catheter with antimicrobial coating • Examples of combination products where the components are packaged together • Drug or biological product packaged with a delivery device 9
Combination Products 10
FDA Organizational Chart Departm tment o of Health th an and H Human S Ser ervice ces Center f r for V Veteri rinary ry Center fo for F Food S Safe fety Medicine ( e (CVM) M) And A Applied N Nutrition on (CFSAN AN) Food a d and Drug A g Admin ministratio ion Cent nter f for B Biol olog ogics Nationa onal C Cent nter f for Evalua uation on and R Research Toxico cological cal R Resear earch (CBER) R) Cente enter f for or T Tob obacco co Prod oducts ts (C (CTP) Cen ente ter for Devic vices an and d Cent nter f for D Drug ug E Evalua uation on Radio adiolo logic ical Healt Health and R Resear earch ( (CDER) (CDR CDRH) 11
Safety & Effectiveness • “There is reasonable assurance that a device is safe when it can be determined based on valid scientific evidence that the probable benefits to health from use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh the probable risks.” • “There is reasonable assurance that a device is effective when it can be determined, based upon valid scientific evidence, that in a significant portion of the target population, the use of the device for its intended uses and conditions of use, when accompanied by adequate directions for use and warnings against unsafe use, will provide clinically significant results.” 12
CDRH Mission The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. 13
CDRH’s Mission Br Bring s saf afe and and effec ecti tive m e medica cal devices ces t to market a et as quickly ly a as possib ible le… … while ile e ensurin ing that m t medical cal d devices ces cur currently on on the the market r et remai ain s n safe e and e effecti ective. *Provide consumers, patients, caregivers, and providers with understandable and accessible science-based information about the products we oversee. Reference: – CDRH Mission, Vision and Share Values 14
The products we regulate… 15
Who We Are CDR CDRH is a team of over 170 700 employees dedicated to public health • Engineers • Microbiologists • Physicians • Nurses >80% of device companies • Biologists • Veterinarians • Chemists • Toxicologists have <50 staff • Physicists • Public Health Education / Communication Specialists • Statisticians • Epidemiologists 16
CDRH in perspective • CDRH oversees: – 175,000 medical devices on US market – 570,000 proprietary brands on the US market – 18,000 medical device manufacturers – 25,000 medical device facilities worldwide – Each year we receive – 22,000 premarket submissions (includes supplements and amendments) – 1.4 million reports on medical device adverse events and malfunctions 17
CDRH Organizational Chart Center nter f for D Devices ces a and R Radiol olog ogical cal H Health th CDRH Ombudsman Office ce o of Office ce o of Office ce o of Office ce o of Compli mpliance Device ce Managem emen ent Survei eillan ance e Evalu luatio ion Operations Ope an and Biometr etrics cs Office ce o of Office ce o of In V n Vit itro Comm mmunic icatio ion Office o e of Sci Scien ence an e and Diagnosti tics cs a and and an Engin gineerin ring Radio iolo logic gical l Educa Ed cation Labor orator ories Heal ealth 18
Office of Science and Engineering Labs (OSEL) Our job is to ensure that CDRH never has to say “ I don ’ t know ” Ensure readiness for emerging and innovative medical technologies • Develop appropriate evaluation strategies and understandable public health info. • Division of Applied Mechanics; Biology , Chemistry and Material Science; • Biomedical Physics; Imaging, Diagnostics and Software Reliability . 19
OSEL Contributions • Providing scientific/engineering expertise, data, and analyses • Conducting laboratory-based regulatory research (Regulatory Science Programs) • Facilitate Innovation & Collaboration https://www.fda.gov/AboutFDA/CentersOffices/Offi ceofMedicalProductsandTobacco/CDRH/CDRHOf fices/ucm115989.htm 20
How to Market a Medical Device 1. Device Determination 2. Device Classification 3. Determine Appropriate Regulatory Pathway 4. Establishment Registration and Device Listing 5. Other Requirements 21
Product Classification Product Classification Data Base https://www.accessdata.fda.gov/scripts/cdrh/c fdocs/cfPCD/classification.cfm 22
Determination & Classification • Cannot determine Device (Y/N) DeviceDetermination@fda.hhs.gov • Cannot determine Classification • 513 g https://www.fda.gov/downloads/medicalde vices/deviceregulationandguidance/guid ancedocuments/ucm209851.pdf • Written Response 23
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