Regulatory/Legislative News

The FDA has issued a draft guidance for the Digital Health and the 21st Century Cures Act, an attempt to clarify its policy for devices with more than one function.

An industry representative participating in a congressional briefing last week on the Fairness to Contact Lens Consumers Act endorsed the use of email to verify prescriptions presented to contact lens retailers.

Johnson & Johnson Vision recommended that the FTC clarify the intent of its proposed changes to the Contact Lens Rule while upholding the brand requirement and non-substitution, the company announced.

Bausch + Lomb announced that it will begin work on a storage case designed specifically for scleral lenses.

On April 24 Gov. Larry Hogan signed HB 1110, which mandates preventive measures to protect children from myopia, dry eye disease and other conditions that may be associated with excessive digital screen use.

The Health Care Alliance for Patient Safety is holding a congressional briefing today to discuss the importance of protecting the safety of patients who wear contact lenses.

A major goal from the recent FTC workshop on the Contact Lens Rule was to evaluate changes in the contact lens marketplace that may create opportunities to obtain lenses safely and at competitive prices, according to Thomas B. Pahl, acting director at the Bureau of Consumer Protection.

The Healthcare Alliance for Patient Safety requested quantity limitations and elimination of robocalls and signed acknowledgment forms in its comments submitted to the FTC on the Contact Lens Rule.

The FDA has granted 510(k) clearance for the Lensar laser system with Streamline IV to include the creation of corneal pockets and flaps for corneal inlay procedures, according to a press release.

The FDA has permitted the marketing of IDx-DR, the first artificial intelligence medical device to detect more than a mild level of diabetic retinopathy in adults with diabetes, according to a press release.