Food and Drug Administration

Food and Drug Administration

(Redirected from USFDA)

The United States Food and Drug Administration (FDA) is responsible for regulating certain aspects of the marketing and labeling of hair removal products and devices.

Contents

Drugs (CDER)

505(b) Approvals for drugs used in treating unwanted hair

Medical devices (CDRH)

This is done through FDA’s Center for Devices and Radiological Health (CDRH) http://www.fda.gov/cdrh/index.html

510(k) Premarket Notification Clearances for medical devices intended to remove unwanted hair

  • Lasers and flash lamps (1976-present)
  • Needle electrolysis (1976-1996)
  • Electric tweezers (1976-1998)
  • Microwaves (1976-present)

Classifies and identifies hair removal devices

Regulation numbers and product codes

Reclassification of electric tweezers (1998)

Reclassification of needle eplators (1996)

Maintains records on hair removal devices

  • Establishment Registration Database
  • Medical Device Listing Database
  • MAUDE Database
  • Consumer complaints

Cosmetics

   Regulates cosmetic products used to dissolve and color hair 

Compliance

Enforces certain labeling and branding claims

  • compliance and surveillance programs
  • Conducts field tests and inspections
  • training of Federal and State compliance personnel.
  • Advises actual or potential manufacturers concerning the requirements of the law and regulations.
  • Enforces the Medical Device Amendments of 1976 including the Safe Medical Devices Acts of 1990 and 1992 and the Radiation Control for Health and Safety Act of 1972 as they relate to promotion and advertising.
  • Develops regulations and Compliance Policy Guides including those related to restricted devices, restricted device labeling, health fraud, and the promotion of devices pending pre-market clearance.
  • issues related to promotion, advertising, and labeling policy.
  • determine off-label promotions.
  • Develops, implements, and manages the Center’s health fraud program. Coordinates activities with National Association of Attorney Generals, and Regional and District health fraud representatives.

Source: FDA website

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