FDA compliance begins with identifying if the products your business manufactures or imports are regulated.
FDA Registration is one of the first steps necessary before placing medical devices including dental lab products, and food including beer, wine and distilled spirits on the market. Managing FDA registration to ensure that the information is current, that changes are made in a timely manner, and that renewals are completed within the required time frame is a challenging task.
Whether your product is food, including beverages such as beer, wine, or distilled spirits, medical devices, or the dental lab products, it is vital to utilize the resources and tools available to you on the FDA’s website. Information can be found specific to each area the FDA regulates. Regulatory compliance solutions are provided through articles and guidance documents. Access is provided to information on the specific regulations affecting your business activities. Go to the FDA page on medical device registration or go to the FDA page on breweries and wineries registration.
Food manufacturers and importers must register with FDA every two years. Medical device manufacturers and importers must register annually. Public databases allow medical device manufacturers as well as consumers access to establishment registration and listing information, research product information such as cleared and approved devices, and complaints and adverse event reporting information.
SafeLink Consulting’s FDA compliance consultants can provide guidance on FDA registration, quality system consulting, and implementation of current good manufacturing practices - gmp for medical device and beverage manufacturers to ensure that your business is doing the best it can to provide products that are both healthy and safe for the public.
Don’t wait until an FDA inquiry to meet registration and clearance requirements. Knowing how to navigate and utilize FDA’s website will make for a less stressful experience when facing an FDA investigation. SafeLink Consulting can help support your FDA compliance program, including quality system and good manufacturing practices requirements. Contact us.
SafeLink Consulting can help your business with:
- determining if your products are regulated by FDA,
- identifying which regulations affect your specific business activity,
- registering your establishment if FDA registration is required,
- renewing your establishment’s FDA registration, and
- ensuring accuracy of registration.
SafeLink Consulting assists:
- medical device manufacturers, including dental custom implant abutments, and
- food manufacturers, including beverage compliance for breweries, wineries and distilleries.
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.
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 / GMP - Good Manufacturing Practices.