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.
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.
Take our online course, How to Navigate Public Info on FDA's Website, to learn more. Get CE credit too!
Course Description: 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. This information will help support your FDA compliance program, including quality system and good manufacturing practices requirements.
Take this course to learn how to:
- use these resources and tools to determine if your products are regulated by FDA,
- determine which regulations affect your specific business activity,
- register your establishment if FDA registration is required,
- renew your establishment’s FDA registration, and
- ensure accuracy of registration.
This course will benefit:
- medical device manufacturers, including dental custom implant abutments, and
- food manufacturers, including beverage compliance for breweries, wineries and distilleries.
This course is presented by Gary Morgan, CDT, ASQ, CQA, SafeLink Consulting's Vice President and Compliance Advisor.
Watch Intro Video:
Visit our website for more information about what SafeLink Consulting can do to help your business with compliance regulations. Let SafeLink Consulting be your FDA compliance consultants.
Get regulatory compliance training courses. SafeLInk Consulting offers live webinars or on demand online compliance courses.