FDA Awards Ninth EUA for Zika Dx August 23, 2016 InBios International's Zika diagnostic yielded the FDA authorization to confirm the presence of Zika virus antibodies. Read More
FDA Categorizes Devices as Class II August 23, 2016 FDA determined the classification of de novo requests. Read More
FDA Advisors Back Approval of Baebies’ Seeker Analyzer for Newborns August 23, 2016 The FDA committee unanimously recommended the product for approval. Read More
FDA Extends Comment Period for Infectious Disease Diagnostic Guidance August 22, 2016 The new deadline is Sept. 12. Read More
FDA to Propose Quality Metrics for Devicemakers by Oct. 1 August 18, 2016 Pre-production metrics were identified as the most difficult to track. Read More
Japanese MHLW Aligns ISO 13485:2016 with Its Own QMS Requirements August 17, 2016 Japan is to merge new quality system standards with its own requirements. Read More
FDA Pursues Feedback on Classification of Antimicrobial Wound Care Products August 17, 2016 These products have not yet been classified. Read More
More Postmarket Data Collection Could Allow Transferal from Class III to Class II August 16, 2016 The reclassification effort is connected with the CDRH’s strategic priorities to reduce premarket data. Read More
FDA, UK Adjust Combination Product Determination Process August 15, 2016 Manufacturers can now engage FDA officials earlier in the process. Read More
Malaysia Updates Labeling, Exemptions, Advertising Rules August 12, 2016 Device regulators in Malaysia have set a two-year transitional period for compliance. Read More
FDA Pilot Program Looks to Streamline Combination Product Efforts August 12, 2016 Effort will start in select offices in CDER, CBER and CDRH. Read More
Guidance Seeks to Unify IEC, FDA Standards for X-Ray Devices August 10, 2016 The agency hopes to streamline the review process. Read More