Medical Devices vs. Beauty Appliances - ACI Cosmetics Conference 2016 - Sharon Blinkoff Locke Lord LLP - American Conference Institute

ACI Cosmetics Conference 2016

Medical Devices vs. Beauty Appliances

             Sharon Blinkoff
              Locke Lord LLP
         200 Vesey Street, 20th Fl.
           New York, NY 10281
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FEDERAL FOOD DRUG AND COSMETIC ACT
(FFDCA)

• The FFDCA (21 U.S.C. § 301 et seq.) is a
  definition driven statute that separately
  defines each FDA regulated product
  category: foods, drugs, cosmetics, dietary
  supplements, and biomedical devices. For
  our purposes, we are only interested in
  one definition; the definition for
  biomedical devices.

DRUGS
• Drugs are defined as:
       (1) articles recognized in the official United States
       Pharmacopoeia, official Homeopathic Pharmacopoeia of the
       United States, or official National Formulary, or any
       supplement to any of them;
       (2) articles intended for use in the diagnosis, cure,
       mitigation, treatment, or prevention of disease in man or
       other animals;
       (3) articles (other than food) intended to affect the structure
       or any function of the body of man or other animals; and
       (4) articles intended for use as a component of any article
       specified in clause (1), (2), or (3) of this paragraph; but does
       not include devices or their components, parts, or
       accessories. 21 U.S.C. § 321(g) (1).

COSMETICS
Cosmetics are defined as:
(1) articles intended to be rubbed, poured, sprinkled or sprayed on,
introduced into, or otherwise applied to the human body or any
part thereof, for cleansing, beautifying, promoting attractiveness,
 or altering the appearance; and

(2) articles intended for use as a component of any such articles;
except that such term shall not include soap.
21 U.S.C. §321(i).

Medical Devices
The term “device” (except when used in paragraph (n) of this section and in
sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument,
apparatus, implement, machine, contrivance, implant, in vitro reagent, or
other similar or related article, including any component, part, or accessory,
which is—
        (1) recognized in the official National Formulary, or the United
        States Pharmacopeia, or any supplement to them,

        (2) 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

        (3) intended to affect the structure or any function of the
         body of man or other animals.

Device Basics
• The Food and Drug Administration (FDA) has established classifications for
  approximately 1,700 different generic types of devices and grouped them
  into 16 medical specialties referred to as panels. Each of these generic types
  of devices is assigned to one of three regulatory classes based on the level
  of control necessary to assure the safety and effectiveness of the device.
  The three classes and the requirements which apply to them are:
•   Device Class and Regulatory Controls
•   1. Class I with exemptions - General Controls
•   2. Class II General Controls and Special Controls – 510k
•   3. Class III General Controls and Premarket Approval
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overvi
  ew/default.htm

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Examples of Reviewed/Approved Biomedical
      Devices with Cosmetic Benefits
  • Silk’n FX Light emitting diode device treatment of periorbital wrinkles
  • Hairmax Hair Growth approved 510k reviewed – Class II
  • Restylane – approved as a device fills lines and wrinkles professional use
    only - Class III PMA
  • Vela Smooth – Reduces thigh circumferences, reduces the appearance of
    cellulite – Class II
  • Skinovations – hair removal, acne – Class II
  • Syneron me – removal of unwanted hair permanent reduction in hair
    growth OTC indication
  • Dentovations Inc. South Beach smile light whitening System K 042153 -
    predicate Glo Science Brilliant Whitening Device – exempt
  • Kate Somerville skincare, LLC Elastomer, Silicone Scar deminishing – exempt
    21 CFR 878.4025

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Vela Smooth Shaper –
K050397
Indications for Use – The Vela smooth Shaper is
indicated for the relief of minor muscle aches and pains.
Relife of muscle spams Temporary improve local blood
circulation. Temporary reduction in the appearance of
cellulite.
Predicates - LPG therapeutic massager, heat lamp, and
theramcool
Device description – simulataneous application of heat
through controlled RF energy and mechanical
manipulation of skin
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HairMax first cleared for male
hair growth in 2007

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Hairmax – predicate devices
• Infrared lamp per 21 CFR 890.5500 lamp non-heating for
  promotion of hair growth
• Predicate Devices
• Device Trade Name Manufacturer Robi Combi Epilady 2000,
  LLC DermaLight Psoracomb Solitec GMBH Quantum WARP 10
  Light Delivery System Quantum Devices, Inc. Lumiphase-R
  Opusmed Inc. TerraQuant MQ2000 Laser Therapy Device
  Escada International, Inc. MLT R694 Ruby Laser System
  Medical Laser Technologies Ltd. L600 Hair Removal A&M
  Technology Violet Ray Device Manufacturer unknown Vacuum
  Cap Evans Raydo and Wonder Brush Dr. Scott
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Capillus 82 Laser cap
hair regrowth FDA Cleared

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Capillus 82
• Indications - The Capillus82 is indicated to
  promote hair growth in females who have
  androgenic alopecia and Ludwig-Savin
  Classifications of I- II; and with Fitzpatrick
  Classification of Skin Phototypes I to IV.
• Prescription Use

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FDA warning letters
• FDA has issued warning letters to manufacturers who
  market devices for hair growth, spider vein removal and
  injectable fillers that make “structure function claims” for
  benefit of appearance that are not the subject of a PMA,
  or cleared under a 510k or otherwise registered as
  exempt devices.
• http://www.fda.gov/Cosmetics/ComplianceEnforcement
  /WarningLetters/ucm081141.htm

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Electric Micro needle pen set
Electric Auto Micro Needle Pen Skin
Therapy for Face, Eyes and Body - Remove
Stretch Marks, Wrinkles, Scars, Acne,
Cellulite, Large Pores, Blackheads, Lines,
Blemishes, 10pcs of 36 Needle Cartridge.
Easier to Operate. No Cord Around the
Neck, Less Pain, Less Bleed and More Safety.

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Derma Pen Auto-Microneedle
Therapy System warning letter
• 21 CFR 878.4820 (Dermabrasion Brush, Powered) are exempt from
  premarket notification. Generic devices of this type have abrasion
  substrates which are brushes, rasps and burrs that are intended to
  abrade and remove layers of the skin via shear force.
• The Dermapen is an automated micro-needling device, with a
  disposable tip cartridge, that uses 11 micro-needles to vertically
  stamp the skin at high speed. The stamping action of the Dermapen’s
  vertical tip creates micro-injuries to the skin, stimulating new
  collagen production. In doing so, these micro-injuries encourage and
  harness the body’s innate ability to regrow and repair the skin
  through normal physiological processes. Dermapen is safe and as
  effective as a fractional laser or intense pulsed light with a
  significantly short recovery period.
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Derma Pen Warning Letter –
continued
• Based on the above, the Derma Pen consists of a stamp of needles that is
  controlled by a motor in order to make multiple controlled-depth penetrations
  perpendicularly into the skin while the operator moves the Derma Pen across
  the skin surface. Unlike Class I exempt powered dermabrasion brushes, the
  Derma Pen is intended to achieve its clinical effect through the creation of many
  small puncture wounds in the skin.
• At this time, the safe ranges of needle lengths, penetration depths, and speeds
  of the device are unknown; therefore, FDA has safety concerns regarding the
  potential for the needles to damage vessels and nerves. FDA previously advised
  your firm of these concerns, including the Agency’s determination that the
  Derma Pen exceeded the Class I exemption status, in its response to your firm’s
  pre-submission (Q140464), dated July 10, 2014.
• Because the Derma Pen Auto-Microneedle Therapy System employs a different
  fundamental scientific technology, it exceeds the limitations described in 21
  C.F.R. 878.9(b) and is not exempt from premarket notification.
• For a device requiring premarket approval, the notification required by section
  510(k) of the Act, [21 U.S.C. § 360(k)], is deemed satisfied when a PMA is
  pending before the agency, 21 C.F.R. 807.81(b).
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Beauty Devices non-medical
devices used for appearance

          Clarisonic Alpha Fit Cleansing

          Clarisonic Opal Sonic Infusion System with
          Anti-Aging Sea Serum
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Thank you!

                                                               Sharon Blinkoff
                                                                  Locke Lord LLP
                                                             200 Vesey Street, 20th Fl.
                                                               New York, NY 10281
                                                                 T: 212 912 2893
                                                          sharon.blinkoff@lockelord.com
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It is not intended to constitute legal advice or to create an attorney-client relationship. If you wish to secure legal advice specific to your enterprise and circumstances in connection
with any of the topics addressed we encourage you to engage counsel of your choice.
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