FDA Registration and Approval

Liberty Management Group Ltd is an internationally known FDA, CE Marking, and ISO consulting business based in Illinois, USA, with Associates and offices worldwide. LMG offers a comprehensive spectrum of FDA regulatory consulting services to both local and overseas organizations.LMG is the ideal choice if you need help with FDA rules, register with FDA, or US FDA Agent requirements. Our knowledgeable and experienced experts can give you outstanding assistance on US FDA regulations. We always offer you an accurate estimate of the entire cost of any project; we will never leave you in the dark with hourly consultation costs. LMG delivers high-quality service at a fair rate and promptly.

Foreign and domestic food facilities that advertise their goods in the United States must register with the FDA and specify the food product category. FDA registration does not imply FDA approval, but it is a legal necessity.LMG assists international and domestic food facilities in registering with the FDA, and we also serve as a US FDA Agent for foreign food facilities. To register your food facility with FDA, please fill out our FDA Food Facility Registration Form. After successfully registering your food facility with the FDA, we will provide you with a complimentary FDA registration certificate. You may check the validity of a certificate on our website, Verify Registration Certificate.

Foreign and domestic businesses that sell medical equipment in the United States must register with the FDA. The FDA charges a user fee for medical device establishment registration; the price for 2021 is USD 5546 per facility. The registration will be active until December 31st. LMG assists medical device makers in registering with the US FDA. To register your medical device facility with the FDA, please fill out our FDA Medical Device Registration Form. After successfully registering your facility with the FDA, we will provide you with a complimentary certificate of registration. Our website allows you to check the validity of a certificate.

LMG assists international and local drug establishments to register with the US FDA and NDC labeler codes and drug listing. To register your Drug Establishment with the FDA, please fill out our FDA Drug Registration Form. After completing Drug registration, we provide a free registration certificate as confirmation of FDA registration. Our website allows you to check the validity of a certificate.

“FDA Approved” is a popular word on product labels, particularly for items sold on the internet. Is it true that they have FDA approval? The FDA will only approve a product after reviewing its safety and efficacy. Most goods do not need FDA clearance to be sold in the United States; just register with FDA is necessary. Furthermore, the FDA does not authorize manufacturing establishments; however, the FDA may perform an audit/inspection to ensure GMP compliance. A successful FDA audit/inspection with no non-compliance does not imply FDA approval of the business.

The FDA does not approve food or food processing facilities. Instead, food establishments must register with the FDA and specify their product categories. Following successful registration, the FDA will give an 11-digit registration number. Food labels must conform with FDA label regulations, but the manufacturer or distributor must ensure that product labels are fully compliant; the FDA will not evaluate or approve food labels. Only new dietary ingredients require FDA clearance, not nutritional supplements. The criteria are facility registration, GMP, label, and ingredient compliance.

Class-I and Class-II medical devices do not require FDA clearance; however, most Class III devices do require approval to be marketed in the States. Class II medical devices require just FDA marketing clearance (510k), not approval. The majority of class I devices have just generic controls. All medical device firms must be FDA registered and have their devices listed.

Only novel dietary components, not dietary supplements, require approval. Facility registration, GMP, label, and ingredient compliance is the must-have record.

OTC Monograph-compliant medicines do not require FDA clearance, whereas other drugs require NDA or ANDA approval. Homeopathic medications that conform with HPUS do not require FDA clearance. All medication must have FDA registration, an NDC labeler code, a drug listing, and label compliance.