EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
Distinguishing Medical Device Recalls
By EAS Senior Consultant Paul F. Tilton Do you know when a product enhancement is considered to be a recall in the eyes of the Food and Drug Administration? If not, I draw your attention to the draft guidance from FDA entitled Distinguishing Medical Device Recalls from Product Enhancements and...
Regulatory Options for Food Ingredients in the U.S.
By EAS Senior Advisor for Food & Color Additive Safety Robert Martin Before releasing any food ingredient into the market, it is incumbent upon the manufacturer/supplier to ensure that the product is safe for its intended use. Oftentimes, deciding how to approach this can be confusing. Under...
On the Proposed Rules for the Safety of Imported Food
One of FDA's biggest challenges as it rolls out new regulations to implement the Food Safety Modernization Act will be outreach and education so every impacted business will know what's expected under the new, prevention-based regulatory approach. As part of its outreach efforts, FDA posted a...
ISO/IEC 17025:2005 and the Benefits of Accreditation
By EAS Senior Consultant Bob Mehta There is immense value for medical device manufacturers in having their calibration and testing laboratory suppliers comply with the General Requirements for the Competence of Testing and Calibration Laboratories in ISO/IEC 17025:2005. From initial design and...
FSMA’s Registration Mandate is the Key
The focus of media attention is currently on FDA's proposed rules for a Foreign Supplier Verification Program and for Accreditation of Third-Party Auditors. But I would draw your attention to a FSMA provision that is already in force, which, from the agency's viewpoint, is the most significant new...