On December 23, 2022, Congress enacted the first major change to the FDA’s ability to regulate cosmetics since the Food Drug & Cosmetic Act. The Modernization of Cosmetics Regulation Act (MoCRA) significantly expands FDA’s rule making and enforcement authority over cosmetics, introducing new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United Sates. It also provides FDA access to cosmetic products records, under certain conditions.
ECI regulatory experts are monitoring the FDA’s communications related to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and can provide support to the cosmetic industry. Beginning in December 2023, the following new requirements come into effect:
- Facility Registration and Product Listing
- Safety Substantiation
- Serious Adverse Event Reporting
- Mandatory Recall Authority
- Standardized Test methods for Talc-Containing Cosmetics
The implementation of MoCRA may sound challenging to cosmetic manufacturers. Taking proactive steps toward MoCRA compliance ensures compliance and safe products. Consider whether you have the regulatory expertise to support an assessment of your products, processes, and procedures. With proper planning, any size business can identify an appropriate solution to meet these new requirements.
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We contracted with ECI-Rx for a multi-year, multi-million-dollar remediation effort focused on updating existing commercially available products to meet state-of-the-art requirements per the Medical Device Directive.
Randy oversaw both project management (budgeting, resource planning and scheduling), as well as technical elements (specification development, test method/validation and risk management), managing day-to-day activities and strategizing with Senior Management.
I developed a strong appreciation for the ECI-Rx team’s skills and knew I could always count on them for high quality deliverables.
M. Adams, MBA, PMP
Project Manager, Endoscopy Sustaining Engineering, Boston Scientific Corporation“Responsive to our needs”
ECI-Rx has helped our company create key Quality System policies and procedures. The ECI-Rx management is very collaborative, engaging and responsive to our needs. They ensured that the work was managed effectively and efficiently.
V. Sheth
Vice President, Corporate Quality, Medtronic“Eager to do things right the first time”
I give my full endorsement to the key attributes that ECI-Rx will bring to your organization. Specifically, their knowledge, professionalism, drive, quality of work and eagerness to do things right the first time will add value to your impending project needs.
Brijesh and Shital were project leads on multiple devices ranging from urology to endoscopy; they remediated well over 1000 finished good codes combined over the course of 2 years. All work has passed multiple audits in the years since.
T. Ragonese
Sr. Process Development Engineer, Boston Scientific Corporation“Technical abilities are outstanding”
Randy, who served as project manager, is very skilled in all aspects of the quality system, with deep understanding of medical device requirements. His strong engineering skills and ability to mentor younger engineers was key to our overall success.
Brijesh and Shital both led specific elements under Randy’s leadership supporting our program. Their technical abilities are outstanding. Each of the 200+ projects within the program had upwards of 50 individual deliverables to meet the overall requirements. The team oscillated well between the multiple design elements, with the goal of meeting the final deliverable.
K. Heffernan
Director of Quality, Corporate Steward, Post Market Processes, Boston Scientific“Professional & Experienced”
Based on their experience, ECI-Rx recommended placing on-site managers to assist with activities and personnel which eased the added strain on our full-time managers due to the number of contracted resources.
I would not hesitate to use ECI-Rx for future projects; I found their professionalism and depth of resources was second to none. We succeeded in completing our mission and owe a great deal of the success to Enhanced Compliance.
J. Lane
Director, Endovascular Engineering and Product Development, Getinge Group, Maquet CardiovascularLearn how ECI-Rx can helpView our list of services