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Devicemakers should err on the side of caution and open a Corrective and Preventive Action (CAPA) investigation even if they are unsure it’s required, said Judith Meritz, life sciences regulatory consultant with Meritz & Muenz, in a recent WCG FDAnews webinar.
Achieving marketing authorization under FDA rules includes submitting your device under the correct classification — and companies can struggle to determine which class a new medical device falls into.
The German-based certification organization DEKRA has temporarily suspended the CE certificates for Getinge’s HLS and PLS life support sets effective March 1 due to noncompliance with the EU’s Medical Device Directive.
Devicemakers may need to consult with their legal counsel during an FDA inspection so they know what the agency may legally request, according to inspection expert David Chesney, principal of DL Chesney Consulting.
Israel-based Medasense Biometrics has received de novo marketing authorization from the FDA for its PMD 200 device that monitors a patient’s pain level while under anesthesia, using artificial intelligence (AI) algorithms to convert data into a patient’s “signature of pain.”
After filing a Special 501(k) requesting a change to its existing device clearance, Signifier Medical Technologies received FDA’s approval to remove a contraindication for its eXciteOSA daytime therapy for obstructive sleep apnea (OSA).
The FDA explains the types of modifications to a diagnostic ultrasound device for which the agency does not intend to enforce the requirement for a new 510(k) filing, in a final guidance released yesterday — one of six newly released guidances from the agency related to imaging solutions and lasers.
The U.S. Supreme Court has refused to review a $302 million judgment levied against Johnson & Johnson (J&J) by California for misrepresenting the risk of its pelvic mesh products in marketing materials.
President Biden has upheld the U.S. International Trade Commission’s final determination that Apple infringed on AliveCor’s wearable electrocardiogram device, keeping alive a limited exclusion order and a cease and desist order on Apple to cease importing certain versions of its watches.