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This edition of Quick Notes reviews the FDA’s approval of Abbott’s transcatheter repair system, Spirair’s nasal septal deviation correction device, de novo approval of Orthobond’s antibacterial coating, and 510(k) clearance of Olympus’ single use ureteroscope system. Read More
Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products. Read More
While Johnson & Johnson just announced its plans to acquire Shockwave Medical for $13.1 billion, Boston Scientific faces an FTC request for more information on its $3.7 billion acquisition of Axonics. Read More
Three medical devices — radial artery and arterial line catheterization kits, a neurovascular catheter, and gas-powered portable ventilators — have been deemed Class I, the FDA’s most serious type of recall. Read More
The FDA questioned and answered virtually all aspects of Remote Regulatory Assessments (RRA) in an 18-page revised draft guidance issued last January, and the comments on the Q&A document have arrived with more questions of their own. Read More
New draft guidance for ceramic and metal coatings on implantable orthopedic devices needs to recognize the different bonding characteristics of a new generation of extremely thin, nonporous metallic coatings applied by ion beam deposition, according to one of seven comments filed on the document. Read More
Three FDA final guidances address electronic submissions for reporting adverse reactions — one for investigational new drug application (IND) safety reports, one for transmitting electronic individual case safety reports (ICSR), another for ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database and a third for expedited ICSRs from certain IND-exempt studies. Read More
A streamlined, more efficient and less burdensome pathway to medical device review is the goal of the Accreditation Scheme for Conformity Assessment (ASCA), a voluntary program the FDA is formally implementing while targeting accreditation bodies, testing labs and device manufacturers. Read More