July 22, 2014 by Arezu Sarvestani
Medicare regulators are looking for feedback on proposed changes to the laws governing transparency in financial relationships between doctors and healthcare companies, warning that the changes may represent a hefty new cost for medical device makers in particular.
The Centers for Medicare & Medicaid Services asked healthcare industry stakeholders to offer comments on 4 proposed modifications to the Physician Payment Sunshine Act, half of which are expected to have little to no practical impact, where the other half may mean a substantial upgrade to existing compliance programs. Read more
July 18, 2014 by MassDevice
New orders from the Indian Ministry of Health & Family Welfare’s Central Drugs Standard Control Organization (CDSCO) clarify some requirements regarding the country’s sometimes opaque medical device registration and clinical trial regulations. Read more
July 21, 2014 by MassDevice
New draft guidance from the US Food and Drug Administration lays out major factors the agency considers when reviewing 510(k) premarket notification applications to make Substantial Equivalence (SE) determinations.
US regulators have issued the new guidance to serve both as a resource for agency reviewers making SE determinations and as a tool for 510(k) applicants to more effectively demonstrate equivalence to predicate devices already on the US market. Read more
July 23, 2014 by MassDevice
Roszdravnadzor, the Russian medical device market regulator, has announcedplans (link in Russian) to develop a new device classification system based on Global Medical Device Nomenclature (GMDN), suggesting perhaps a regulatory approach more harmonized with international standards than previous Russian registration requirements.
Roszdravnadzor’s announcement includes a spreadsheet of more than 20,000 medical device types and descriptions. Regulators are accepting comments on the proposed system, but have not set firm deadlines or rollout dates as of yet. Read more
July 17, 2014 by Arezu Sarvestani
The FDA posted a warning letter against California-based Spinal Elements, saying that the company failed to obtain regulatory clearance for design changes to certain of its intervertebral body fusion devices.
Agents inspected Spinal Elements’ Carlsbad facility early this year, dubbing the company’s Lucent and Lucent Ti-Bond devices “adulterated” under FDA law. The FDA further chided the company for “unsubstantiated claims” made about the Ti-Bond device that the agency never approved. Read more