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Devicemakers in the EU need to make sure they have at least two or three employees who are prepared to handle an audit, as notified bodies begin conducting unannounced audits required by the European Commission. Read More
Devicemakers should be prepared to justify their test methodology in 510(k) submissions for highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostics, or HMMDs, newly finalized FDA guidance says. Read More
The FDA has warned Masimo’s Irvine, Calif., facility over complaint issues, failure to establish and maintain procedures for implementing corrective and preventive action, and failure to investigate the causes of nonconformities. Read More
Medical devicemakers are rebutting IRS claims that a significant portion of the industry is failing to pay the new 2.3 percent medical device excise tax, resulting in tax collections that are 21 percent below expectations. Read More
Notified bodies should conduct unannounced audits of facilities that make Is/Im and in vitro diagnostic self-tests every two years if the product carries a high risk, is often noncompliant with EU regulations or otherwise raises concerns about manufacturing and quality deviations, Team-NB says in its updated industry conduct code. Read More
Industry is raising concerns about a new Turkish regulation that bans advertisements of certain medical devices and requires device sales centers to be government-certified and employ “qualified” persons. Read More
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
Manufacturers are all but blocked from using split predicates for 510(k) devices, under a newly finalized U.S. Food and Drug Administration guidance on substantial equivalence determinations. Read More
For the first time, manufacturers submitting 510(k)s would have to show U.S. Food and Drug Administration reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is strengthening its ability to respond to postmarket medical device safety issues by creating a fast-acting committee of expert advisors that can rapidly review safety problems. Read More
Manufacturers of moderate-risk devices with a good record of GMP compliance could see less of government inspectors, under proposed amendments to South Korea’s good manufacturing practice regulations. Read More