Meshing Drug and Device Manufacturers in Risk Management
Differing approaches to risk could hamper further growth of combination products.
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.
Stringent REACH Standards Make Devices Safer in European Union
REACH, which stands for the Regulation, Evaluation, Authorization and Restriction of Chemicals, is a standard that was established by the European Union (EU) in 2007 but does not go into effect until 2018. Simply put, REACH immediately seeks to “limit or prohibit the use of toxic substances in products.” According to an article written by…
Device Meet Drug: Integrating Combination Products Into Your Portfolio
Combination products are a major growth area for life science companies and in the future, many companies have or will have combination products in their portfolio. Combination products are made of drug, device and/or biologics constituent parts. Each constituent part has its own set of regulations to which it must adhere. For example, even if…
Health Hazard Evaluations: Focus on Complaints and the Patient
When a product recall occurs, typically there are complaints that can be traced back to trending issues with the specific device. During the process of assessing whether a correction or removal must take place, a company should be conducting a health hazard evaluation (HHE) to determine whether a violation has occurred. Several considerations come into…
Biomaterial Constraints Could Limit Progress of 3D Printing
For 3D printing to thrive in the medical device space, the use of biomaterials must be expanded.
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.
Changes to ISO 13485: What to Expect
A summary of the new and revised changes in ISO 13485, the second Draft International Standard (DIS2), which is planned for release this fall.
A summary of the new and revised changes in ISO 13485, the second Draft International Standard (DIS2), which is planned for release this fall.
Going Global: Should You Take the Leap?
Before moving into the global market, a company needs to understand the local structure of geographic regions.
Before moving into the global market, a company needs to understand the local structure of geographic regions.