NEMA tries to derail GMP revision

Article

The Food and Drug Administration wants to revise the good manufacturingpractices (GMP) regulations in the U.S., calling them out of stepwith European quality assurance standards. The National ElectricalManufacturers of America has proposed an

The Food and Drug Administration wants to revise the good manufacturingpractices (GMP) regulations in the U.S., calling them out of stepwith European quality assurance standards. The National ElectricalManufacturers of America has proposed an alternative. Rather thanrewrite existing rules, why not just adopt the European standards?

"NEMA is concerned that the FDA's proposed changes tothe medical device GMP greatly exceed the requirements of Europeanquality assurance," said Robin Wiley, NEMA spokesperson.Rather than fight over the proposed changes, NEMA has focusedon the stated goal of the FDA: to bring rules in this countryinto harmony with those in Europe.

"(Adopting the standard) would pave the way for GMP inspectionand certification agreements with the European Community,"said Robert Britain, director of the NEMA diagnostic imaging andtherapy systems division. "Since Canada has proposed thatits GMP will be based on ISO 9001, (the same) would also be possiblewith Canada," Britain wrote in a Feb. 28 letter to the FDA.

NEMA has taken the position that its proposal is consistentwith the Congressional establishment of an office of internationalrelations within the FDA. The office is supposed to facilitatemutual recognition of quality assurance standards among countries,according to Wiley.

Newsletter

Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.

Recent Videos
SNMMI: Emerging PET Insights on Neuroinflammation with Progressive Apraxia of Speech (PAOS) and Parkinson-Plus Syndrome
Improving Access to Nuclear Imaging: An Interview with SNMMI President Jean-Luc C. Urbain, MD, PhD
SNMMI: 18F-Piflufolastat PSMA PET/CT Offers High PPV for Local PCa Recurrence Regardless of PSA Level
SNMMI: NIH Researcher Discusses Potential of 18F-Fluciclovine for Multiple Myeloma Detection
SNMMI: What Tau PET Findings May Reveal About Modifiable Factors for Alzheimer’s Disease
Emerging Insights on the Use of FES PET for Women with Lobular Breast Cancer
Can Generative AI Reinvent Radiology Reporting?: An Interview with Samir Abboud, MD
Mammography Study Reveals Over Sixfold Higher Risk of Advanced Cancer Presentation with Symptom-Detected Cancers
Combining Advances in Computed Tomography Angiography with AI to Enhance Preventive Care
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
Related Content
© 2025 MJH Life Sciences

All rights reserved.