Tonometers - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff

Description

FDA has developed thisguidance documentto assist industry in preparing premarket notification submissions for contact and non-contact tonometers. The device is intended for measuring intraocular pressure (IOP).

Scope & Applicability

Regulatory Context

• 21CFR801.109§ 801.109 Prescription devices.

  A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →

• 21CFR807.81§ 807.81 When a premarket notification submission is required.

  (a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →

• 21CFR807.87§ 807.87 Information required in a premarket notification submission.

  Each premarket notification submission shall contain the following information:Read full regulation →

• 21CFR886.1930§ 886.1930 Tonometer and accessories.

  (a) Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk tRead full regulation →

• 21CFR812.2§ 812.2 Applicability.

  (a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →

• CGMP/QSR/Medical Devices/Adulterated

  Envoy Medical Inc.

  2025-12-09

• CGMP/QSR/Medical Devices/Adulterated

  Hong Qiangxing Shenzhen Electronics Limited

  2025-11-25

• CGMP/QSR/Medical Devices/Adulterated

  Contec Medical Systems Co., Ltd.

  2025-10-28

• CGMP/QSR/Medical Devices/Adulterated/Misbranded

  Royal Philips

  2025-10-28

• CGMP/QSR/Medical Devices/Adulterated/Misbranded

  Qianjiang Kingphar Medical Material Co Ltd.

  2025-10-28

• CGMP/QSR/Medical Devices/Adulterated

  LEVO AG

  2025-10-21

• CGMP/QSR/Medical Devices/Adulterated

  Technological Medical Advancements LLC

  2025-10-07

• Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

  The Richline Group, Inc.

  2025-09-23

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

  SeniorLife Technologies, Inc.

  2025-09-16

• Clinical Investigator

  Shirish M. Gadgeel, M.D.

  2025-09-09

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