Tag: Intraocular Lens
FDA UDI Final Rule
Food and Drug Administration The Unique Device Identification (UDI) Final Rule On September 24, 2013, the FDA published a final rule establishing a unique device identification system (the UDI Rule). The UDI Rule outlines labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the U.S., unless an exception or alternative applies. The rule will be
UDI Compliance Date Extended for Class III Contact Lens and Intraocular Lens Labelers
Extension Letter to Class III Contact Lens and Intraocular Lens Labelers August 15, 2014 FDA issues the following letter. Dear Class III Contact Lens and Intraocular Lens Labelers: Effective August 15, 2014, the FDA’s Center for Devices and Radiological Health (CDRH) is granting a 1-year extension of the September 24, 2014 Unique Device Identification System (UDI) compliance date for the
Medical Device Alert | Intraocular Lens | MHRA
By Regulatory Doctor; LinkedIn; Google Plus; Twitter Intraocular lens, one-piece foldable posterior chamber Title Medical Device Alert: Intraocular lens, one-piece foldable posterior chamber manufactured by HOYA Surgical Optics (MDA/2013/021) Summary This Medical Device Alert has been issued due to higher than expected rates of inflammation and/or endophthalmitis observed following implantation of affected intraocular lenses. CAS deadlines Action underway: 9 April 2013, action complete:16
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- FDA Guidance on Expansion of the Abbreviated 510k Program
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