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An Overview of Medical Device
Regulations in the U.S.
ISCT North America Regional Meeting
September 8, 2013
Yong Fan, MD
FDA/CBER/OCTGT/DCGT
Phone: 301-827-6038
Email: [email protected]
What will we cover?
• Device definition
• Device regulatory history
• Device classifications
• Device regulatory pathways
• Examples of devices that are regulated by
OCTGT
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What is a Device?
• An instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other
similar or related article… which is intended for
use in the diagnosis, cure, mitigation, treatment,
or prevention of disease;
or
• Is intended to affect the structure or any function
of the body of man or other animals
AND
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What is a Device (continued)
• Does not achieve its primary intended
purposes through chemical action within or
on the body of man and is not dependent
on being metabolized to achieve its
primary intended purposes.
21 U.S.C. § 201(h)
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Medical Device Regulatory History
• Medical Device Amendments are signed into law
on May 28,1976
– FDA begins regulating and classifying medical
devices
– Code of Federal Regulations (CFR)
• Initial classification of over 1700 generic device types legally
on the market
• Regulations describe the device type as it existed prior to
May 28, 1976
• Product Codes Are Created
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Device Regulation Is Risk Based
Section 513(a)(2) of the FD&C Act requires FDA to
determine safety and effectiveness of a device by
weighing any probable benefit to health from the
use of the device against any probable risk of
injury or illness from the use.
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Device Classification
• Three Regulatory Classes
• Level of control, based on risk, necessary to
provide reasonable assurance of safety and
effectiveness of a device type:
– Class I – General Controls
– Class II – General Controls & Special Controls
– Class III – General Controls & Premarket Approval
Application (PMA)
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Description of Classes-Class I 513(a)(1)(A) & 21 CFR 860.3(c)(1)
• Devices for which general controls are sufficient
to provide reasonable assurance of safety and
effectiveness.
OR
• It is unclear if general controls alone are
sufficient to provide reasonable assurance of
safety and effectiveness but the device is not
life-supporting, life-sustaining, or of substantial
importance in preventing impairment of human
health
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General Controls
• Establishment registration and product listing
• Prohibition against misbranding and
adulteration
• Premarket notification requirements
• Good manufacturing practice
• Records and reports
• Repair, replacement, refund
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Description of Classes-Class II
513(a)(1)(B) & 21 CFR 860.3(c)(2)
• Devices which cannot be classified into Class I because
general controls by themselves are insufficient to provide
reasonable assurance of safety and effectiveness,
BUT
• For which there is sufficient information to establish
performance standards or special controls, to provide
such assurance.
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Special Controls (usually device-specific)
• Performance standards
– National or international consensus standards recognized by
rulemaking
– Voluntary standards
• Guidance documents
• Special labeling requirements
• Postmarket surveillance
• Patient registries
• Other actions (the agency decides are necessary to provide
reasonable assurance of safety and effectiveness)
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Description of Classes-Class III
Sec 513(a)(1)(C) & 21 CFR 860.3(c)(3)
• Devices for which insufficient information exists to determine that
general and special controls are sufficient to provide reasonable
assurance of safety and effectiveness;
AND
• Such devices:
– Are life sustaining or life supporting;
– Are of substantial importance in preventing impairment of human
health; or
– Present potential unreasonable risk of illness or injury.
• Premarket approval (PMA or HDE) is required by definition
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Device Regulatory Pathways
• Exemption from premarket review
• Premarket Notification-510(k)
• Humanitarian Device Exemption-HDE
• Premarket Approval-PMA
• Biologic License Application (BLA)
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Device Regulatory Pathway
(Determined by the device regulatory class)
• Class I = exempt from premarket review unless 510(k) is
required by regulation
• Class II = 510(k) required unless exempt from 510(k)
requirements by regulation
• Class III = PMA required (applicant must demonstrate
safety and effectiveness of its device without relying on a
grandfathered/predicate device)
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Premarket notification-510(k) (Section 510(k) of FD&C Act, 21 CFR 807 Subpart E)
• Mostly class II medical devices
• Most common path to market devices
• FDA reviews to determine Substantial Equivalence (SE)
• Compare a new device to a predicate device
– Pre-amendment device (legally marketed before
5/28/76)
– Cleared by FDA (determined to be SE to a legally
marketed device)
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510(k) Types
• Traditional
• Special –limited modifications to one’s
own cleared device
• Abbreviated –relies on special controls,
guidance documents, and recognized
standards
• De Novo-allows reclassification of novel
class III (no predicate) to a class II device 16
How does FDA determine SE
• Indications for use/intended use
• Technical characteristics
The subject device should either have the same
Indications for use/intended use and technical
characteristics, or the differences (in these two
elements above) do not raise new type of safety
or effectiveness questions (if different)
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Premarket Approval (PMA)
• Class III-General and special controls insufficient
to assure safety and effectiveness
• Generally supported by clinical study under IDE
to show safety and effectiveness
• Submission can be traditional or modular
• FDA has 180 days to approve or disapprove
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Humanitarian Use Device (HUD) Section 520(m) of the FD&C Act and 21 CFR 814
subpart H
“… to encourage the discovery and use of devices
intended to benefit patients in treatment and
diagnosis of diseases or conditions that affect fewer
than 4,000 individuals in the United States.” [yearly]
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Humanitarian Device Exemption (HDE)
Provide incentive for development of devices
intended for treatment or diagnosis, in small
patient populations where otherwise a
device manufacturer’s R&D costs could
exceed market returns
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HDE vs. PMA
• Both are marketing approvals
• Both subject to post-market Medical
Device Reporting (MDR) requirements
• Approval thresholds differ:
– PMA: safety and effectiveness
– HDE: safety and probable benefit
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Biologic License Application (BLA)
• Some medical devices such as blood and
HCT/P donor screening testing devices
are approved under the BLA pathway
• Generally supported by clinical study using
healthy donors as subjects under IND
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Examples of devices reviewed by
OCTGT (1)-Cell Selection Device
• Using antibodies conjugated to beads or similar
concept to select or deplete cells: Isolex and
CliniMACS
• Class III medical devices
• Require PMA or HDE
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Examples of devices reviewed by OCTGT
(2)-Cell Processing Device
• Apheresis device for mononuclear cell or
hematopoietic stem cell collection
• Cord blood processing devices
• Certain storage containers such as
freezing bags for HCT/Ps
• Mostly class II, require 510(k) 25
Examples of devices reviewed by
OCTGT (3)-Combination Products
• Scaffolds seeded with cells
• Cell delivery devices
• Regulatory pathways (PMA or BLA) depend on
the primary mode of action
• Sponsor may contact OCTGT or CBER
Jurisdiction officer, or submit a Request for
Designation (RFD) to the Office of Combination
Products (OCP)
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Examples of devices reviewed by OCTGT
(4)-Platelet-Rich Plasma (PRP) Device
• Produce PRP from a small sample of blood or mixture of blood and
bone marrow (autologous)
• The device output is PRP
• Intended to be used to mix with bone graft materials to enhance
bone graft handling properties in orthopedic practices; not intended
for direct patient application such as injection or implant without prior
mixing with the bone graft materials.
• PRP devices using a mixture of blood and bone marrow are cleared
with limitations: They can only be marketed as PRP device with the
same intended use (mixing with bone graft materials)
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Thank you!
Questions?
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OCTGT Contact Information
• Regulatory Questions:
Contact the Regulatory Management Staff in OCTGT at
or by calling (301) 827-6536
• OCTGT Learn Webinar Series:
http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/
ucm232821.htm
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Public Access to CBER
• CBER website:
http://www.fda.gov/BiologicsBloodVaccines/default.htm
Phone: 1-800-835-4709 or 301-827-1800
• Consumer Affairs Branch (CAB)
Email: [email protected]
Phone: 301-827-3821
• Manufacturers Assistance and Technical Training Branch (MATTB)
Email: [email protected]
Phone: 301-827-4081
• Follow us on Twitter
https://www.twitter.com/fdacber
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