Article
Closing The Gender Gap In Digital Health Technologies
Four questions for developing inclusive digital solutions by identifying women-specific requirements and endpoints
Exponent
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New Federal Rules Limit Imports Of EV Batteries From "FEOCs"
As the world leader in the production of electric vehicles and the materials powering them, China dominates the global EV market,Exponent - Article
EPA Releases National Strategy To Prevent Plastic Pollution
On Nov. 21, the Environmental Protection Agency released the final version of its National Strategy to Prevent Plastic Pollution.Exponent - Article
California To Create PFAS Regulatory Enforcement Program
Assembly bills 347 and 2515 require California's Department of Toxic Substances Control to enforce product testing for PFAS...Exponent - Article
EPA, FDA & USDA Plan For Biotechnology Regulatory Reform
The biotechnology landscape has evolved rapidly over the past few decades, including significant advancements involving microbes.Exponent - Article
FDA Drafts New Guidance On Thermal Effects Of Medical Devices
On March 15, the Food and Drug Administration issued new draft guidance that impacts premarket submissions for all medical devices that produce temperature changes in patient tissues...Exponent - Article
FDA Finalizes Guidance On DHTs For Remote Data Acquisition
New guidance provides recommendations to ensure digital health technologies are fit-for-purpose for collecting high-quality clinical data to evaluate medical products.Exponent - Article
FDA Releases Final Guidance On Viral Safety Of Biotech Products
Agency recommends methods for virus detection and clearance for biotechnology manufacturers and products derived from animal or human cell lines...Exponent - Article
What KOSPA Could Mean For Child Safety And Privacy
In July 2024, the U.S. Senate voted in favor of advancing S. 2073: Kids Online Safety and Privacy Act (KOSPA).Exponent - Article
NHTSA Proposes New EV Safety Standards
The National Highway Traffic Safety Administration (NHTSA) has proposed updated regulations that build on the current federal safety standards for electric vehicles and promote...Exponent - Article
FDA's Cosmetics Direct Portal Now Open For MoCRA Submissions
The 2022 Modernization of Cosmetics Regulation Act requires cosmetics manufacturers update facility registrations and product listings by July...Exponent - Article
EPA Restricts EtO Emissions From Medical Device Sterilizers
Final rule requires a 90% reduction in ethylene oxide emissions from commercial medical device sterilization facilities...Exponent - Article
New Guidance On PCCPs Expanded To Include All Medical Devices
The Food and Drug Administration recently issued new draft guidance, Predetermined Change Control Plans for Medical Devices, that allows predetermined change control plans...Exponent - Article
EPA Finalizes Ruling On 329 PFAS Chemicals
Manufacturers will need the Environmental Protection Agency's approval to use PFAS chemicals on the Toxic Substances Control Act "inactive" list.Exponent - Article
EPA Proposes New Exposure Data Reporting Requirement
Agency proposes data reporting rule for unpublished health and safety studies as part of risk evaluation process under Toxic Substances Control Act...Exponent - Article
FDA Issues Draft Guidance For Medical Device Biocompatibility
The Food and Drug Administration released a draft guidance document for medical device manufacturers and FDA staff titled "Chemical Analysis for Biocompatibility Assessment of Medical Devices."Exponent - Article
2024 Updates To EPA's Safer Choice Standard
The agency has finalized enhancements to its ecolabel program, introducing new criteria to bolster sustainability and safeguard human healthExponent - Article
FDA Proposes Updates To Animal Study Guidelines For Dental Bone Graft Devices
The agency has published new draft guidance to support manufacturer compliance with special controls...Exponent - Article
New EPA Rules For Methane Emissions Reporting
EPA's final rules for monitoring methane emissions could lead to more fines for the oil and gas industryExponent - Article
How Can Fresh Perspectives Improve Product Safety?
Safety design review is a critical step in the product development process, supporting the performance, safety, and reliability of finished products.Exponent