During this meeting, the Ophthalmic Devices Panel of the Medical Devices Advisory Committee discussed.
During this meeting, the Ophthalmic Devices Panel of the Medical Devices Advisory Committee discussed and made recommendations regarding the guidance documents for contact lens and contact lens accessory/care manufacturers.
The FDA presented on the demographics and noncompliance of contact lens users; interactions of contact lens materials with multipurpose care product solutions, a grouping system for silicone hydrogel contact lenses, a potential screening method to assess preservative uptake and lens solution incompatibilities of contact lenses, variables that may impact care product disinfection efficacy from a microbiological perspective, the impact of using tap water as a rinsing agent in the care of Rigid Gas Permeable (RGP) lenses and labeling for these devices.
A guest speaker, from the CDC, presented a summary of their Acanthamoeba keratitis investigations from 1985 – 2011 in addition to their Healthy Contact Lenses Program.
The overall message from this meeting was that the Agency should not require manufacturers to be responsible for patient noncompliance regarding the use of their products.
Additionally, panelists recommended premarket testing to include newer silicone hydrophilic lenses when evaluating lens and solution compatibilities in addition to conventional hydrophilic material lenses. Additionally, they suggested testing 9 lens types (instead of 4), defined by water content and ionic vs. nonionic types.
Approximately 80% of lens wear complications result from patients not complying with directions on how to wear and care for lenses; often, from soaking the lenses in solution for far longer than recommended by manufacturers.
Additionally, panel members pointed out that exposure to water while wearing contact lenses has been associated with the development of Acanthamoeba keratitis, but many makers of rigid gas-permeable lenses continue to recommend use of water for rinsing. Panelists were widely split on the issue, with some saying there was not enough evidence to implicate tap water as the primary source of complications and others saying the contrary. In addition, several panel members said, simply, no good substitute exists for tap water, although untreated tap water can be a problem.
The FDA published the last premarket guidelines for daily wear of contact lenses in 1994 and the last premarket guidelines for contact lens care products in 1997. The investigation into possible guideline changes was provoked upon the outbreak of two keratitis outbreaks. Both outbreaks (2006 & 2007) led to the voluntary recall of two multipurpose contact lens solutions.
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact firstname.lastname@example.org.
Do you have an upcoming Advisory Committee Meeting?
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us