Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear - Guidance for Industry and FDA Staff

Description

Document issued on: August 11, 1998This document supersedes document, "New Procedures for Adding Lens Finishing Laboratories Through Supplements to Approved Premarket Approval Applications for Rigid Gas Permeable Contact Lenses," May 9, 1985

Scope & Applicability

Regulatory Context

• 21CFR814.39§ 814.39 PMA supplements.

  (a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →

• 21CFR820.3§ 820.3 Definitions.

  The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.Read full regulation →

• 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 →

• 21CFR814.84§ 814.84 Reports.

  (a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the device by other regulations in this subchapter or by order approving the device.Read full regulation →

• 21CFR803.10§ 803.10 Generally, what are the reporting requirements that apply to me?

  (a) If you are a device user facility, you must submit reports (described in subpart C of this part ), as follows:Read full regulation →

• Medical Devices/Adulterated/Quality System Regulation (QSR)

  iRhythm Technologies, Inc.

  2023-06-06

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

  Tenderneeds Fertility LLC

  2020-04-21

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