Legal consequences of the FDA's 7-day extended wear letter.
The U.S. Food and Drug Administration (FDA) recently sent contact lens practitioners a letter advising them that the FDA had asked manufacturers to indicate a maximum recommended wearing time of 7 days for cosmetic extended wear soft contact lenses. This paper discusses the authority of the FDA and the legal consequences of the FDA's "7-day Letter." Congress has authorized the FDA to enact rules, guidelines and recommendations. The 7-day letter does not appear to be any of the above. However, it does have a significant effect on contact lens practitioners' professional responsibilities and legal obligations because the letter has led to changes in product labeling and the standard of care for extended wear patients. Practitioners would be wise to give careful consideration to any deviation from the FDA's recommendation and the provisions of the product labeling. As any deviation will likely impose greater legal responsibility on the practitioner, the special circumstances that justify the deviation should be thoroughly documented in an informed consent agreement.
Dister
R E
RE
University of California, School of Optometry, Berkeley 94720.
Harris
M G
MG
D003262:Contact Lenses, Extended-Wear / Q000009:adverse effects / Q000592:standards; D006801:Humans; D007258:Informed Consent; D008318:Malpractice; D015337:Multicenter Studies as Topic; D010349:Patient Compliance; D014481:United States; D014486:United States Food and Drug Administration