It’s that time of year again! If your facility is registered with FDA, October 1 begins the very important renewal period. Renewal must be accomplished by December 31 in order for the registration to remain active.
The official correspondent for the facility should receive notification that renewal needs to be accomplished. It is very important that the official correspondent information is correct so that the renewal notification and any other communication from FDA is received in a timely manner. It is very prudent for the chief executive officer of the facility to review the registration information on a routine basis to ensure that the information is correct, especially if there has been a change in the official correspondent or in the business activities of the facility which might cause the registration to be revised.
Remember that the renewal process takes two steps to complete. The annual payment must be made first through the Facility Device User Fee website and a payment confirmation must be received before the renewal can be made through the registration and listing website. It is best to complete this process earlier than later. Waiting until late December may cause delays in receiving the payment confirmation and even failure to complete the process in time. Learn more about Device Registration and Listing. Begin the renewal payment process.
Any updates to the listing information can be made at any time, but the renewal process is a good time to review the listings for accuracy. The correct product codes and activity descriptions are very important as this information is used by FDA in determining the schedule for inspections. If the facility is no longer engaging in in a regulated activity, then the registration should be inactivated. Do not just let a registration lapse as even the information will remain in the database and the facility may receive a letter requesting to update the information or even notification of inspection. SafeLink can provide assistance with this process so that it is completed correctly. Contact SafeLink Consulting for help.
FDA Inspections Are On the Rise For Dental Labs - learn more
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Learn more about who must register with FDA, list and pay the fee. Contact SafeLink Consulting for help with FDA registration.
Have questions about your dental lab quality system or need FDA compliance assistance? SafeLink Consulting can assist your business with developing a Quality System and Good Manufacturing Practices - GMP for medical devices manufacturers including the dental lab, workplace health & safety training, infection control training and HIPAA training online, plus more. Learn more about FDA Dental Regulations.
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).
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