Has your business been registered with the FDA? Have you updated your registration for the new year?
The renewal period begins on Oct 1st for FDA renewal registration for Medical Device Manufacturers including dental laboratories. The renewal period ends on December 31st of each year and every registered establishment is required to pay the renewal fee. If you have forgotten, renew the registration immediately to prevent any compliance issues. If you decided not to register, due to ceasing a registered activity, do not just let the registration lapse. You may also decide to just inactivate some listings and not the entire registration. You should inactivate your registration either online, if possible, or by contacting FDA directly. The registration status stays active with FDA even if you do not complete the renewal process. FDA may contact you at any time in the future about the registration status, and may even inspect to confirm the status. Learn more about the 7 Steps to Successfully Navigating FDA Renewal Registration.
Get 7 Steps to Successfully Navigating FDA Renewal Registration
The renewal period for FDA registration for Medical Device Manufacturers, including dental laboratories, starts on October 1st. This period concludes on December 31st each year, and all registered establishments must pay the renewal fee. If you've forgotten, renew your registration promptly to avoid compliance issues. If you choose not to register due to stopping a registered activity, do not simply let your registration expire. You may choose to inactivate certain listings rather than the entire registration. You should inactivate your registration online, if possible, or by contacting the FDA directly. The registration remains active with the FDA even without completing the renewal process. The FDA may reach out to you anytime in the future regarding your registration status and may conduct an inspection to verify it.
Get Tips for FDA Registration Renewal
Have questions about your dental lab quality system or need FDA compliance assistance? Contact SafeLink to learn more about how we can help your business with FDA registration or a Quality Management System. Get help with improving efficiencies and business results through QMS Internal Auditing.
Learn more about Device Registration and Listing for Medical Devices. and Food Facilities Registration.
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.
