Engineers at theU.S. Food and Drug Administration

CDR Brad Cunningham, CDRHCDR Josh Simms, OC/OEO

LCDR Abbas Bandukwala, CDERLCDR Matt Palo, ORA

LCDR Samantha Spindel, CTPLCDR Jit Virani, CDRH

FDA 101

www.fda.gov

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Regulator and Public Health Agency• FDA regulates ~20% of the U.S. GDP• Started in 1906 with Pure Food and Drugs Act• Derive authority from the Food, Drug, and

Cosmetic Act and the PHS Act• Notable changes in last decade include

– FSMA– Generic Drugs– Tobacco Regulation– FDASIA*

www.fda.gov

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Organization

www.fda.gov

Office of the Commissioner

Office of Emergency Operations

OGROP

ORA

OIP

CDRH CDER CBER CFSAN CVM CTP

FY2017 Budget Authority: $4.7 billionApproximately 14,000 FTEOpDiv with second most PHSCC officers• as of April 2018, 1148 officers total• 86 engineers

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Major Regulatory Responsibilities• Approve prescription drugs (brand name and

generic)• Approve high-risk medical devices• Clear moderate-risk medical devices• License biological products• Regulate tobacco products, including preventing

underage use• No approval of foods, dietary supplements, or

cosmetics, instead ongoing review of safety through inspections and surveillance

www.fda.gov

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Office of the Commissioner

www.fda.gov

• The Office of Emergency Operations (OEO) serves as FDA’s focal point for emergency and incident coordination with FDA Headquarters offices, Product Centers, and ORA District Offices.

• OEO responds to and provides interagency coordination for:– Adverse events– Some foodborne illnesses– Injuries– Product tampering – Manmade and natural disasters

• Manages the National Consumer Complaint System• Assists in the development of emergency operations plans &

procedures, and the implementation of related training and exercise programs.

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Center for Devices and Radiological Health (CDRH)

• FDA regulates more than $2.4 trillion worth of medical products, food, and tobacco

• Roughly 20 cents of every dollar spent by consumers– $200 billion in human food– $105 billion in human and animal drugs– $110 billion in Medical Devices

www.fda.gov

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What is a medical device?• 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 its primary intended purposes through chemical action within or on the body of man or other animals and

• which does not achieve its 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 its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).

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Class I: General Controls• Prohibition of adulterated or misbranded devices• Good Manufacturing Practices (GMPs)• Registration of manufacturing facilities• Listing of device types• Record keeping• Repair, replacement, refund• Most Class I devices now exempted from

Premarket notification [510(k)]

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Class II: General plus Special Controls• Performance standards

(e.g., ANSI, ASA, ISO, ASTM)• Guidance documents• Device tracking• Patient registry• Most require Premarket Notification

[510(k)] to show substantial equivalence to a legally marketed “predicate” device

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Class III: General Controls plus PMA Typically reserved for devices that:

Support/sustain human life, or Have substantial importance in preventing health

impairment, or

Potential unreasonable risk of illness or injury

Premarket Approval (PMA)

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User Fees (FY18)510(k)‡ $10,566 $2,642

513(g) $4,195 $2,098

De Novo classification $93,229 $23,307

PMA, PDP, PMR, BLA $310,764 $77,691

panel-track supplement $233,073 $58,268

180-day supplement $46,615 $11,654

real-time supplement $21,753 $5,438

BLA efficacy supplement $310,764 $77,691

PMA annual report $10,877 $2,719

30-day notice $4,972 $2,486

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CDRH Specifics• Approximately 85 officers • Most FDA-based engineers are in CDRH• Four main areas at CDRH where engineers are

best positioned:– Office of Device Evaluation– Office of Science and Engineering Laboratories– Office of Surveillance and Biometrics– Office of Compliance

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CDRH – Office of Device Evaluation (ODE)

• Premarket review activities for medical devices– Evaluation of engineering design characteristics – Evaluate testing design and results– Evaluate impact of device design attributes and

output on safety and effectiveness (performance)• Postmarket review activities for medical devices

– Assess impact of any device changes against original approval specifications in the context of indicated use

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CDRH – Office of Science and Engineering Laboratories (OSEL)

• Research arm of CDRH– Support the evaluation of medical devices

• Ensure readiness for emerging and innovative technologies

• Develop appropriate evaluation strategies and testing standards

• Create accessible and understandable public health information

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Office of Surveillance and Biometrics (OSB)

• OSB is responsible for ensuring the continued safety and effectiveness of medical devices after premarket authorization

• Surveillance of medical device reports– Evaluation of failure modes and root cause

investigations– Signal management to develop new policies,

guidance, and standards for significant safety issues– Predict failure modes

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CDRH – Office of Compliance (OC)• Protect and promote public health by

evaluating, enhancing, and ensuring compliance with medical device laws

• Evaluate recalls and assess corrective actions• Evaluate manufacturing processes and

procedural changes

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Center of Drug Evaluation and Research (CDER)

Overview

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• Office Of Center Director• Office Of Communications• Office Of Compliance• Counter Terrorism and Emergency Coordination Staff• Office of Executive Programs• Office of Generic Drugs• Office of Management• Office of Medical Policy• Office of New Drugs• Office of Pharmaceutical Quality• Office of Regulatory Policy• Office Of Strategic Programs• Office Of Surveillance and Epidemiology• Office Of Translational Sciences

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What is a DrugA drug is any product that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; and that is intended to affect the structure or any function of the body.

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Which products does CDER regulate?

Cough dropsFlu shots and other vaccinesBlood pressure medicationsDietary supplementsVitaminsToothpastes

Yes/NoYes/NoYes/NoYes/NoYes/NoYes/No

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When is CDER Involved?

• During drug development/ investigational phase

• Pre-market review

• Post-approval

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Types of Drugs• Prescription (Rx)

– New Drug Application ($2,421495) (NDA) Generic Drug/ Abbreviated New Drug Application (ANDA) counterparts

– Biologic License Application (BLA) Biosimilar follow-ons

• Over-the-Counter (OTC)/Nonprescription Products

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New Drug Application (NDA) and Biologic License Application (BLA)

The registration document that contains all relevant data to allow the FDA to review and decide whether to approve marketing of a new drug.

200,000 pages in 400 volumes

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New Drugs1. Laboratory Tests/Studies2. Animal Studies3. Clinical Studies4. Bioavailability5. Pharmacology/Toxicology6. Chemistry7. Manufacturing8. Controls9. Microbiology10.Inspection11.Testing12.Labeling

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Review Team

• Medical Officers/Clinicians• Chemists• Pharmacologists/Toxicologists• Microbiologists

- for Anti-viral/Anti-infective Drugs- for sterility issues

• Biopharmaceutists/Pharmacokinetists• Statisticians• Project Managers• Support Staff

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10 PHS Engineers

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CTP• Pre- and Post-Market Activities

– Cigarettes, cigarette tobacco, smokeless tobacco, roll-your-own tobacco

– Cigars, Pipes, Waterpipes, Electronic Nicotine Delivery Systems (ENDS), novel products

• Writing Regulations and Guidance Documents• Knowledge Development• Research

www.fda.gov

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ORA• ORA is the lead office for all FDA field activities, with locations

nationwide• Majority of engineers serve in multi-disciplinary positions

– Regulatory officers conduct inspections, domestic and foreign, of regulated industry

– Research officers perform analytical work in ORA laboratories– Program management officers serve in management roles at all levels of

ORA• Engineer-specific positions at WEAC

– Lead laboratory for medical device and radioanalytical testing– Only FDA facility that performs analyses of the Medical Device Program

areas including device sterility and device safety– WEAC is designing parameter testing for the electronic components of e-

Cigarettes, batteries, and test methods

www.fda.gov