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  • Regulatory NewsRegulatory News

    FDA Flags 41,000 Adverse Event Reports Linked to Surgical Staplers, Staples

    The US Food and Drug Administration (FDA) sent a letter to health care providers Friday over a growing body of adverse events associated with surgical staplers and implantable staples.   The agency’s ongoing analysis of medical device reports (MDRs) found that it received more than 41,000 individual MDRs that describe adverse events associated with the use of surgical staplers and staples for internal use between 1 January 2011 and 31 March 2018.   These include 36...
  • Regulatory NewsRegulatory News

    FDA Warns Singapore Ophthalmic Drug Manufacturing Site

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 16 March to Singapore-based Opto-Pharm for its failure to address leaking containers and bottle defects, among other violations. FDA notes that the company, which manufactures sterile eye and skin washes , documented "numerous leaking containers and other bottle formation defects" and subsequently received consumer complaints of leaking containers after adjusting its equipment and resumi...
  • Regulatory NewsRegulatory News

    New FDA Warnings for Anesthetic Use in Young Children and Pregnant Women

    The U.S. Food and Drug Administration (FDA) on Wednesday warned that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than three years or in pregnant women during their third trimester may affect the development of children’s brains. The warning comes as FDA says recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikel...
  • Regulatory NewsRegulatory News

    Association Calls on FDA to Regulate Online Vision Exam as Medical Device

    The American Optometric Association (AOA) has submitted a complaint to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) over an online eye exam that may not accurately generate prescriptions for eyeglasses or contact lenses. The complaint is directed at Opternative , which is marketing its online eye exam directly to consumers and claiming that it can provide a prescription for eyeglasses or contact lenses “as accurate as an i...
  • Regulatory NewsRegulatory News

    FDA Warns California Ophthalmologist Again Over Clinical Trial Violations

    For the second time since 2000, the US Food and Drug Administration (FDA) has sent a warning letter to a Newport Beach, California-based ophthalmologist over objections to a clinical trial run by him. The latest letter, released Tuesday, claims that Dr. Thomas Tooma of the NVISION Laser Eye Centers ran a clinical trial at seven sites with an unapproved drug without first submitting an investigational new drug (IND) application to FDA as required by law. “Your investig...
  • Regulatory NewsRegulatory News

    Fallout Continues from MHRA Suspension of Brazilian Manufacturer's Implants

    Two days since the UK's Medicines and Healthcare products Regulatory Agency (MHRA) halted all sales of Silimed's silicone implants, and at least two other regulators have followed suit, while Silimed insists its devices are safe and has criticized MHRA's criteria for particle levels. Background MHRA on Wednesday suspended the CE certificates of the Brazilian device manufacturer Silimed, which claims to be the largest manufacturer of silicone implants and the largest b...
  • Feature ArticlesFeature Articles

    The Science Behind What You See

    No other sense organ is as critically important to the activities of daily living as our eyes. This article, which describes sight and the vision process, is the third in a series the author is writing about the five senses. Articles on hearing and smell were published in Regulatory Focus in 2013. 1,2 This article briefly discusses eye anatomy, the miracle of vision, the evolution of sight and ocular diseases (cataracts in particular), and provides references for furth...
  • Regulatory NewsRegulatory News

    Do 'Distractions' in DTC Advertising Affect Patient Risk Perception? FDA Wants to Know

    The US Food and Drug Administration (FDA) has put the finishing touches on a proposed eye-tracking study intended to assess how patients assess the benefits and risks of direct-to-consumer (DTC) drug advertising when subject to on-screen "distractions." FDA has conducted similar research in the past, it notes in its 27 May 2014 Federal Register announcement. Prior eye-tracking research determined that consumers understand drug risks better when they are simultaneously ...
  • FDA Tightens Limits on Endotoxin Testing for Some Eye Surgery Devices

    The US Food and Drug Administration (FDA) is warning manufacturers of intraocular ophthalmic devices that they must do more to reduce the risk of their devices being contaminated with the endotoxins which cause Toxic Anterior Segment Syndrome (TASS) outbreaks. The warning came in the form of a new draft guidance document, Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices , released on 17 April 2014. The guidance notes that national outbr...
  • FDA Reclassifies Ophthalmic Device, Issues Special Controls

    The US Food and Drug Administration (FDA) has announced that it will reclassify stainless steel scleral plugs as class II medical devices, thereby allowing the devices to be approved under the premarketing notification process [510(k)] instead of the premarket approval process. Background Scleral plugs are used to temporarily close scleral-the sclera is the white of the eye-incisions made during eye surgery. For example, during a trabeculectomy, a small circular hole is...
  • Regulatory Considerations of Glaucoma Devices Focus of FDA Meeting

    Officials from the US Food and Drug Administration (FDA) are planning to hold a workshop in October to study the use, validity and reliability of medical devices used to image glaucomas, the agency announced in a Federal Register posting . A glaucoma is a type of eye disorder that negatively affects the optic nerve, usually because of increased pressure on the nerve, which can lead to worsened vision or blindness. In recent years, imaging devices have come to defi...
  • US, British Pharmacopoeias Tout Effort to Harmonize Drug Standards

    • 15 May 2012
    • By
    The US Pharmacopoeia (USP) and the British Pharmacopoeia (BP) have announced the harmonization of two drug product quality standards for two eye drop medications-a first for the two groups and an effort that could lead to more cooperation between the two groups in the future. The newly-harmonized standards cover dorzolamide hydrochloride ophthalmic solution and dorzolamide hydrochloride-timolol maleate ophthalmic solution, and are included in the Pharmacopeial Forum 38(...