Background, scope and key requirements of the FDA’s proposed TPMP rule for e-cigarette manufacturers, with documentation, inspection and timeline expectations.
What a Premarket Tobacco Product Application contains, whether clinical studies are needed, how FDA reviews it, and practical tips for applicants.
Why FDA clearance alone is not enough for IVD instruments in US hospitals and laboratories, and how to choose a Nationally Recognized Testing Laboratory (NRTL).
Why NRTL certification is often overlooked by IVD manufacturers, a typical case of shipment delays, and how to plan certification and factory inspections.
For IVD instruments with wireless functions, FDA clearance and NRTL certification must be complemented by FCC equipment authorisation and FDA cybersecurity requirements.
What the FDA’s January 2025 safety communication on the CMS8000 patient monitor revealed, and how FDA, EU and NMPA cybersecurity requirements have tightened.
A practical structure for the performance evaluation report of an IVD under the IVDR – from product description and risk analysis to scientific validity, analytical and clinical performance.
What an IVDR performance evaluation plan must contain under Annex XIII, how to demonstrate scientific validity, analytical and clinical performance, and how to tackle common challenges.
Extended IVDR transition deadlines for legacy devices under Regulation (EU) 2024/1860, the conditions that apply and the actions manufacturers must take.
Purpose, ethics and design of IVDR clinical performance studies, the content of the clinical performance study plan (CPSP) under Annex XIII and the study report.
