Classification Overview
FDA Small Business
Regulatory Education for Industry (REdI)
Silver Spring, MD
September 29, 2015
William M. Sutton
Deputy Director
Division of Industry and Consumer Education
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Learning Objectives
• Understand the history and terminology
associated with device classification
• Identify and describe the three classes of
devices
• Describe general controls and special controls
• Search the product classification database
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Classification History
May 28, 1976 – Medical Device Amendments
• Section 201(h) of Federal Food, Drug &
Cosmetic Act (FD&C Act)
– Provides definition of a medical device
• FDA classification panels conducted initial
classification of preamendments medical
devices, i.e., Class I, II, III
• Initial classification completed in mid-1980s
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A medical device is…
Section 201(h) of the FDCA defines a
medical device as any product that
does not achieve its purposes by
chemical action or metabolization.
– As simple as a tongue
depressor
– As complex as robotic surgery
devices
.
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What is a
Preamendments Device?
• In commercial distribution before May 28, 1976
• Preamendments Class III devices require
premarket approval (PMA) after FDA publishes
regulation in the Federal Register (FR)
• Preamendments Class III devices may require
premarket notification [510(k)], i.e., until FDA
publishes a regulation
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What is a
Postamendments Device?
• First distributed commercially on or after May 28,
1976
• Automatically classified as Class III PMA, until
FDA publishes a regulation
• Equivalent requirements to preamendments
Class III devices, e.g., PMA or 510(k)
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What is a Transitional Device?
• Regulated as new drug before May 28, 1976,
e.g., intraocular lenses
• Any Class III transitional device now regulated
as a PMA
• FDA application number begins with letter “N”
• Some have been downclassified to Class II
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Is my Product a Device?
• If unable to determine if product meets the
definition of a medical device, may seek FDA
advice.
• Contact CDRH Office of Compliance by email at:
DeviceDetermination@[Link]
• Provide product description, draft labeling, and
intended use
Device Advice Reference: 8
[Link]
Classification “Terms”
• Classified
– Formally classified by FDA classification panel or FDA,
– Example: 21 CFR 880.2910 - Clinical electronic
thermometer
– Class II 510(k)
• Un-classified
– Preamendments device pending formal classification
with regulation, i.e., Class III 510(k)
• Not Classified
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– Postamendments device under application review
Device Classification
• Classification determines extent of regulatory
control (risk-based)
• Regulatory Control increases from Class I to III
• Medical Specialty, e.g., cardiovascular
• Product Codes
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Device Classification
• 1700 generic groups of devices
• Classified within 16 medical specialties
– 21 CFR 862-892
862 = Chemistry/Toxicology 878 = General Plastic Surgery
864 = Hematology/Pathology 880 = General Hospital
866 = Immunology/Microbiology 882 = Neurological
868 = Anesthesiology 884 = Obstetrical/Gynecological
870 = Cardiovascular 886 = Ophthalmic
872 = Dental 888 = Orthopedic
874 = Ear, Nose and Throat 890 = Physical Medicine
876 = Gastro/Urology 892 = Radiology
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Classification System
Risk Categorization
• Class I ~780 Low Risk
– General Controls
• Class II ~800 Moderate Risk
– General Controls and
– Special Controls
• Class III ~120 High Risk
– General Controls and
– Premarket Approval
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General Controls
• Adulteration/Misbranding
• Electronic Establishment Registration
• Electronic Device Listing
• Premarket Notification [510(k)]
• Quality Systems
• Labeling
• Medical Device Reporting (MDR)
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Special Controls
• Guidelines (e.g., Glove Manual)
• Mandatory Performance Standard
• Recommendations or Other Actions
• Special Labeling
example: 21 CFR 882.5970, Cranial Orthosis
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Class I – General Controls
• Level of Device Risk may be sufficiently
managed by least amount of regulatory
control
• Device Examples
– adhesive bandage
– I.V. stand
– sunglasses
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Class I – General Controls
Examples of General Controls
• Establishment Registration and Listing
• Quality System Regulations
• Labeling
• Premarket Notification [510(k)],unless exempt
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Class II – Special Controls
• General controls alone are insufficient to
assure safety and effectiveness
• Device Examples:
– syringe, surgical mask, powered wheelchair
• Special Controls
– special labeling
– mandatory performance standard
– guidelines
17
Class III – Premarket Approval
(PMA)
• Insufficient information exist to assure S&E
solely through general or special controls
• Device Examples
– heart valves, implantable neuromuscular stimulator
• Class III is the most stringent category
• Support or sustain human life
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Classification of New Devices
• “New” means that the device has not
previously been classified
• By default, these devices are classified into
Class III and require PMA approval,
regardless of risk
• Regulatory burden may exceed what is
necessary
• Potential Option: de novo
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Classification of New Devices:
de novo
de novo is a classification process:
using a risk-based strategy
for new, novel devices whose type has not
previously been classified
would be classified into Class III
to classify into Class I or II
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After de novo is granted
• New Device is Legally Marketed
– Subject to post-market requirements applicable to that device
and class (including general controls, special controls as
applicable)
• New Device Establishes New Classification
– The subject device is eligible to serve as a predicate for new
medical devices, where appropriate [510(k) process]
– New “device type” along with classification, regulation, class
(either Class I or II), necessary controls and product code
• FDA publishes order announcing new classification,
controls
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Why is Classification Important
to You?
• How to classify your device?
– regulation number
– classification database or device panel
– product code
– [Link]
docs/cfpcd/[Link]
22
Product Classification Database
[Link]
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Advanced Search Options
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Syringe, Piston
Device Regulation
Name Number
Medical Device Class
Specialty
Recognized
Product Consensus
Code Standards
Premarket Guidance
Review Document
Office
Submission
Type
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21 CFR Parts 800 - 1299
a) Identification:
– intended use
– technological characteristics
b) Classification:
– intended use/indications for use
– technological characteristics
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Regulations and Product Codes
Regulation Number: 880.5780
a)(1) Medical support stocking to prevent the
pooling of blood in the legs.
2) Class II and requires 510(k).
•Product code DWL
b)(1) Medical support stocking for general medical
purposes.
2) Class I and is exempt from 510(k).
•Product code FLL
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How is My Device Classified?
• CDRH provides non-binding, informal advice
on device classification and regulatory
requirements.
• Section 513(g) submission to CDRH
• 60 day review cycle
• FY16 User Fee:
– standard: $3529; small business: $1,765
• 513(g) guidance document:
[Link]
uidance/guidancedocuments/[Link]
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Summary
• Terminology of device classification will assist in
proper classification
• Correct classification of your device will outline
the regulatory requirements
• Complying with general and special controls will
assure timely review decisions and compliance
• Proper search of the product classification
database will achieve successful results 29
Industry Education Resources
Three Resources
1. CDRH Learn – Multi-Media Industry Education
over 80 modules
videos, audio recordings, power point presentations, software-based “how to” modules
mobile-friendly: access CDRH Learn on your portable devices
[Link]
2. Device Advice – Text-Based Education
comprehensive regulatory information on premarket and postmarket topics
[Link]
3. Division of Industry and Consumer Education (DICE)
Contact DICE if you have a question
Email: DICE@[Link]
Phone: 1(800) 638-2014 or (301) 796-7100 (Hours: 9 am-12:30 pm; 1 pm-4:30pm EST)
Web: [Link]
DivisionofIndustryandConsumerEducation/[Link]
Questions?
Please complete the session survey:
[Link]/r/DEV-D1S2
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