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The agency noted that it is seeking feedback on all elements of the guidance, including the benefits and risks of smooth and textured breast implants. Read More
Devicemakers should assess cybersecurity risks throughout the product lifecycle, the International Medical Device Regulators Forum (IMDRF) says, in a new draft guidance that calls for “convergence of global healthcare cybersecurity principles and practices.” Read More
The FDA is introducing a new review program for certain medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition deemed less serious than those eligible for the breakthrough devices program. Read More
The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Read More
The FDA is establishing a pilot accreditation scheme for conformity assessment (ASCA) whereby testing laboratories may be accredited by accreditation bodies to assess the conformance of a device within certain FDA-recognized standards. Read More
The European Commission released final guidelines for devicemakers, notified bodies and regulators on how to perform a benefit-risk analysis for phthalates in medical devices. Read More
The FDA offers new advice for devicemakers on 510(k) submissions for guidewires used in coronary, peripheral and neurovasculature in a final guidance released last week. Read More
A new final guidance from the FDA allows some sponsors of oncology products to file a single application for use of an investigational diagnostic in their trial rather than filing for the drug and device components separately. Read More
In a newly released guidance, the FDA spells out what manufacturers need to consider when labeling catheters, wires and delivery systems with lubricious coatings used during minimally invasive diagnostic and therapeutic vascular procedures. Read More