The US Food and Drug Administration (FDA) last week granted a third extension for soft contact lens labelers yet to comply with the requirements of the Unique Device Identification (UDI) system because of the agency’s resource limitations. Background In September 2013, FDA published a final rule creating a UDI system and outlining labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the US, unless a...

Some medical device manufacturers will have an additional year to comply with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, a 2013 regulation intended to allow regulators to exercise greater oversight of the device industry. Background A UDI is, as its name implies, a system of identifying each medical device using a specific system. The system has a number of allures for regulators. "The unique device identification system will h...

A warning letter sent to Rochester, NY-based medical device manufacturer Bausch & Lomb, Inc by the US Food and Drug Administration (FDA) accuses the company of marketing its PureVision 2 contact lenses using an explicitly unapproved indication. In its 11 June 2012 letter, FDA explains Bausch submitted a supplement for the device-a tinted contact lens with an approved indication for extended wear -to the agency in 2010 seeking approval for a revised labeling stat...

A new manual of policies and procedures (MAPP) released by the US Food and Drug Administration's (FDA) Office of Management (OoM) dictates how the Center for Drug Evaluation and Research (CDER) must maintain adequate and consistent phone coverage to allow regulatory professionals and the public to reach the agency during normal business hours. "As Federal employees and public servants, CDER employees must be responsive to the needs of the public," writes OoM. "The public...

The Chinese State Food and Drug Administration (SFDA) today released a bevy of documents including the fourth national drug quality and medical device quality announcements of 2011, guidance on test methods for hydrocortisone present in cosmetic products, notice of their intent to regulate colored contact lenses as medical devices and strengthen regulations regarding the production and management of clenbuterol. The notices commented that SFDA had been made aware of the ...