Tips for FDA Registration Renewal

Don't forget to complete your FDA registration renewal before the end of the year if your establishment is registered with FDA. 

The renewal period runs from October 1 to December 31st annually, and all registered establishments are required to pay the renewal fee. The new fee will be announced by FDA each year.

To ensure a smooth renewal process, it's best to start organizing everything as early as possible and avoid procrastinating until the last minute, which could lead to complications. Learn more about Device Registration and Listing for Medical Devices. Learn more about Food Facilities Registration.

Here are a few tips that can make the process quick and relatively painless:

• Locate the user names and passwords for the Medical Device User Fee website and the FDA Universal Registration and Listing System (FURLS). They are not the same! If you cannot locate them, you can get them reset. The earlier the better!
• Log into the FURLS system and review all of the company information to ensure that it is correct. Update if necessary.
• Make sure the official correspondent information is accurate, especially the email address. FDA communicates by email, so the renewal reminder will be sent to this email address.
• If you do not receive this notice soon after Oct 1, then check spam or junk mail folders.
• You do not have to receive the email in order to proceed with the renewal however, remember FDA may send other notifications to this email address, so ensure that it is correct.
• Don’t wait until the last day to renew. Once the renewal payment is made it can take 2 -3 days to receive the Payment Confirmation Number that will allow the renewal to be completed in the FURLS website.
• Credit card payments and electronic checks are processed much faster than mailing a payment.
• Learn more by taking this online course: Dental Lab FDA Registration Made Easy.
• Learn more about FDA Dental Regulations
• 7 Steps to Successfully Navigating FDA Renewal Registration

What can SafeLink Consulting do for my business?

We address your business needs whether they are a basic quality system to meet FDA compliance or an expanded quality system to improve good business practices. We provide customized programs specific to your business model. Get help with improving efficiencies and business results through QMS Internal Auditing.

SafeLink Consulting offers dental labs the whole package on quality systems, safety programs, patient security and chairside services plus compliance with FDA, OSHA & HIPAA.  For over 25 years SafeLink has been helping the dental industry with compliance. Our staff, including CDT’s and former lab owners, has over 100 years of combined experience in the dental environment.  SafeLink also has Authorized OSHA Outreach Trainers on staff, DAMAS certification auditors, and third-party quality auditors on staff who are ASQ certified.

Our clients also benefit from our broad experience with Quality System development for other medical device manufacturers. We also offer risk assessments, cloud-based data management programs, ISO registration and FDA 510k submission assistance. We are one of the premier FDA consulting firms in the dental industry assisting labs with medical device US import requirements. Our FDA compliance consultants are knowledgeable of the dental environment. Learn more about specific quality/FDA topics by taking any of our educational, online courses available 24/7 when it’s convenient for you.

Contact us to learn more.

Are you a manufacturer of dental devices?  Need Quality System consulting or other dental compliance services?

Here's what SafeLink Consulting can do for you: 

• Quality Management consulting
• Quality Management training online courses
• Quality System Regulation Risk Assessment
• FDA consultants
• 510k consultants
• Quality System Manual
• Digital Document Control Management Program
  
  

  Learn more about what SafeLink Consulting can do to help your business with compliance services, including safety compliance, to meet OSHA training requirements and quality system consulting to meet FDA compliance.  SafeLink Consulting assists businesses with workplace safety training, infection control training, HIPAA training online, quality systems, assessments, audits, due diligence, and more.

  Industries include:

  Dentistry compliance - assisting the dental practice with meeting requirements for OSHA, HIPAA, EPA, and CDC guidelines, patient safety and employee health & safety

  Dental Laboratory compliance - assisting the dental lab with meeting requirements for OSHA, FDA, and CDC guidelines, employee health & safety, plus FDA requirements for lab manufacturing custom implant abutment /gmp for medical device manufacturers

  Medical Device Manufacturers compliance - assisting with meeting OSHA compliance & FDA requirements, GMP - good manufacturing practices

  General Industry compliance - assisting with OSHA compliance and FDA compliance as it pertains to the specific business

  Beverage Industry compliance - assisting beverage businesses such as the craft brewery, winery, cidery, distillery, vintner with meeting OSHA compliance, health & safety, FDA requirements / CGMP - Current Good Manufacturing Practices, and FMSA - Food Safety Modernization Act (FMSA).