Predetermined Change Control Plans (PCCP) for Medical Devices
The FDA has recently issued a draft guidance for Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance,…
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FDA Guidelines: Medical and In Vitro Diagnostic Device Classification
Classifying your medical device or in vitro diagnostic device (IVD) under the FDA is one of the first steps in…
Personal Protective Equipment (PPE): Regulatory Requirements
Personal protective equipment (PPE) is a daily necessity in many occupations, including healthcare, and it is important to understand their…
FDA Final Ruling on LDTs (Laboratory Developed Tests)
T…
Post-Market Surveillance (PMS) and Vigilance: US & EU Guide
According to the EU MDR, post-market surveillance (PMS) is the “proactive,…
Prioritizing Device Regulatory Approval: FDA Approval or CE Mark
With a projected revenue in 2024 of US $182 billion and an estimated annual growth rate of 5.49% (CAGR…
What is Substantial Equivalence Under the FDA?
The concept of ‘substantial equivalence’ is the foundation of the US…
FDA eSTAR Program Simplifying Medical Device Regulatory Submissions
Since its initial pilot and coming into force for non-exempt 510(k) submissions in October 2023, the FDA eSTAR Program…
Navigating the Current US FDA Medical Device Classification
For manufacturers looking to enter the US medical device market for the first time, the US FDA approach to…
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