[Congressional Record (Bound Edition), Volume 151 (2005), Part 14]
[Senate]
[Page 19334]
[From the U.S. Government Publishing Office, www.gpo.gov]




            REGULATION OF CONTACT LENSES AS MEDICAL DEVICES

  Mr. FRIST. I ask unanimous consent that the Senate proceed to the 
immediate consideration of Calendar No. 177, S. 172.
  The PRESIDING OFFICER. The clerk will report.
  The legislative clerk read as follows:

       A bill (S. 172) to amend the Federal Food, Drug, and 
     Cosmetic Act to provide for the regulation of all contact 
     lenses as medical devices, and for other purposes.

  There being no objection, the Senate proceeded to consider the bill 
to amend the Federal Food, Drug, and Cosmetic Act to provide for the 
regulation of all contact lenses as medical devices, and for other 
purposes, which had been reported from the Committee on Health, 
Education, Labor, and Pensions, with an amendment.

       [Strike the part shown in black brackets and insert the 
     part shown in italic.]

                                 S. 172

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     [SECTION 1. FINDINGS.

       [Congress finds as follows:
       [(1) All contact lenses have significant effects on the eye 
     and pose serious potential health risks if improperly 
     manufactured or used without appropriate involvement of a 
     qualified eye care professional.
       [(2) Most contact lenses currently marketed in the United 
     States, including certain plano and decorative contact 
     lenses, have been approved as medical devices pursuant to 
     premarket approval applications or cleared pursuant to 
     premarket notifications by the Food and Drug Administration 
     (``FDA'').
       [(3) FDA has asserted medical device jurisdiction over most 
     corrective and noncorrective contact lenses as medical 
     devices currently marketed in the United States, including 
     certain plano and decorative contact lenses, so as to require 
     approval pursuant to premarket approval applications or 
     clearance pursuant to premarket notifications.
       [(4) All contact lenses can present risks if used without 
     the supervision of a qualified eye care professional. Eye 
     injuries in children and other consumers have been reported 
     for contact lenses that are regulated by FDA as medical 
     devices primarily when used without professional involvement, 
     and noncorrective contact lenses sold without approval or 
     clearance as medical devices have caused eye injuries in 
     children.

     [SEC. 2. REGULATION OF CERTAIN ARTICLES AS MEDICAL DEVICES.

       [Section 520 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360j) is amended by adding at the end the 
     following:

                [``Regulation of Contact Lens as Devices

       [``(n)(1) All contact lenses shall be deemed to be devices 
     under section 201(h).
       [``(2) Paragraph 1 shall not be construed as having any 
     legal effect on any article that is not described in that 
     paragraph.''.]

     SECTION 1. FINDINGS.

       Congress finds as follows:
       (1) All contact lenses have significant effects on the eye 
     and pose serious potential health risks if improperly 
     manufactured or used without appropriate involvement of a 
     qualified eye care professional.
       (2) Most contact lenses currently marketed in the United 
     States, including certain plano and decorative contact 
     lenses, have been approved as medical devices pursuant to 
     premarket approval applications or cleared pursuant to 
     premarket notifications by the Food and Drug Administration 
     (``FDA'').
       (3) FDA has asserted medical device jurisdiction over most 
     corrective and noncorrective contact lenses as medical 
     devices currently marketed in the United States, including 
     certain plano and decorative contact lenses, so as to require 
     approval pursuant to premarket approval applications or 
     clearance pursuant to premarket notifications.
       (4) All contact lenses can present risks if used without 
     the supervision of a qualified eye care professional. Eye 
     injuries in children and other consumers have been reported 
     for contact lenses that are regulated by FDA as medical 
     devices primarily when used without professional involvement, 
     and noncorrective contact lenses sold without approval or 
     clearance as medical devices have caused eye injuries in 
     children.

     SEC. 2. REGULATION OF CERTAIN ARTICLES AS MEDICAL DEVICES.

       Section 520 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360j) is amended by adding at the end the following:

                ``Regulation of Contact Lens as Devices

       ``(n)(1) All contact lenses shall be deemed to be devices 
     under section 201(h).
       ``(2) Paragraph (1) shall not be construed as having any 
     legal effect on any article that is not subject to such 
     paragraph.''.

  Mr. FRIST. I ask unanimous consent that the DeWine amendment be 
agreed to, the committee-reported amendment, as amended, be agreed to, 
the bill, as amended, be read a third time and passed, the motion to 
reconsider be laid upon the table and that any statements relating to 
the bill be printed in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 1647) was agreed to, as follows:

              (Purpose: To provide a complete substitute)

       In lieu of the matter to be inserted, insert the following:

     SECTION 1. REGULATION OF CERTAIN ARTICLES AS MEDICAL DEVICES.

       Section 520 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360j) is amended by adding at the end the following 
     subsection:

                ``Regulation of Contact Lens as Devices

       ``(n)(1) All contact lenses shall be deemed to be devices 
     under section 201(h).
       ``(2) Paragraph (1) shall not be construed as bearing on or 
     being relevant to the question of whether any product other 
     than a contact lens is a device as defined by section 201(h) 
     or a drug as defined by section 201(g).''.

  The committee amendment in the nature of a substitute, as amended, 
was agreed to.
  The bill (S. 172), as amended, was passed.

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