FDA Announces Cybersecurity Public Workshop
The agency will bring together major stakeholders to discuss challenges in medical device cybersecurity.
Tag Archives: CDRH
Two Key Processes You Must Know as a Combination Product Manufacturer
When preparing a regulatory submission, there are a couple of critical elements to consider.
FDA Takes Design Validation Seriously
If you haven’t made the connection yet, you’re in trouble.
CDRH Releases 2016 Priorities
Leveraging big data and clinical evidence is top of mind.
CDRH’s Shuren: Future is Bright, We Need to Take Risks
As the agency continues to try to do more with fewer resources, taking additional risks is imperative to move forward.
What Are Complaints and How Does FDA Handle Them?
CDRH’s Carl Fischer shares the agency’s approach to organizing and managing complaints.
Combination Products Progressing in Fits and Starts
The creation of the Office of Combination Products more than a decade ago may have been a big step forward, but frustrations surrounding policy-making and coordination between CDRH, CDER and CBER remain.
The OIG Work plan: Potential Implications for Medical Device Manufacturers and Suppliers
This year’s work plan includes several items that will impact medical device manufacturer and suppliers.
FDA Transparency at Heart of Device Risk and Recall Discussion
The last decade has brought more interaction between the device industry and FDA related to conducting health hazard evaluations, but companies continue to face obstacles.
The last decade has brought more interaction between the device industry and FDA related to conducting health hazard evaluations, but companies continue to face obstacles.
Build the Right Medical Device Recall Team
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.
