SafeLink Consulting Blog

Don't Forget to Review Your Facility's FDA Registration

Gary Morgan, CDT, ASQ CQA
Posted by Gary Morgan, CDT, ASQ CQA on Dec 28, 2021 7:06:24 PM

Is your business registered with FDA? Have you renewed your registration for the upcoming year?


The renewal period begins on Oct 1 for FDA renewal registration for Medical Device Manufacturers. 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.

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.

FDA Inspections Are On the Rise For Dental Labs - Learn more

Learn more about Device Registration and Listing for Medical Devices. 

Learn more about 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 moreLearn 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).


 

Topics: general, dental lab, quality system, FDA compliance

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