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Faced with long waits for Brazilian good manufacturing practice certificates, some devicemakers are turning to the courts to speed up product registrations — and seeing their time to market cut in half, an expert says. Read More
Manufacturers should use a two-step approach to grade nonconforming products — a matrix for determining the initial number, followed by escalations to set a final grade, according to a proposed guidance released last month by the Asian Harmonization Working Party. Read More
The FDA has released a previously announced warning letter to spine implant maker Globus Medical, citing the company for releasing five lots of MicroFuse putty that did not meet its own specification for mechanical testing. Read More
CDRH’s Office of Compliance is sharpening its focus on international inspections and audits and on labeling, adding two new divisions to meet increasing enforcement demands. Read More
The FDA has granted Japan’s Sumitomo Heavy Industries its first 510(k) clearance for a 23 MeV cyclotron proton beam radiation therapy device that targets cancer cells. Read More
Devicemakers seeking regulatory approval in the U.S. are strongly urged to blind patients and investigators in pivotal clinical trials, when possible, according to final guidance issued by the Food and Drug Administration. Read More
Kiwi devicemakers are crying foul over proposed fee structures for the Australia New Zealand Therapeutic Products Agency, saying they will stifle innovation among smaller medtech companies and limit access to new technologies. Read More
Medtech sponsors should balance the need to demonstrate safety and efficacy with the potential risks to patients when determining the size and duration of a clinical trial, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
The U.S. Food and Drug Administration has created a new Division of International Compliance Operations to oversee inspections of foreign devicemakers and the international audit program. Read More
The International Medical Device Regulators Forum adopted four final guidance documents and two new work items relating to the Medical Device Single Audit Program during a meeting in Brussels last month. Read More