The cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023 begins on October 1 and runs through September 30. Between October 1, 2022, and December 31, 2022, the yearly establishment registration fee must be paid. A reduced small company charge is NOT applicable to the establishment registration fee.
The FDA defines a small company as one with gross receipts or sales of $100 million or less, including those from its affiliates. Additionally, a small company that has sales or gross receipts of $30 million or less is qualified to have the first PMA, PDP, PMR, or BLA fee waived.
21 CFR part 820 – Medical Device GMP
GMP regulations must be followed by American medical device manufacturers as well as international manufacturers who distribute their products here. A quality management system must be put in place by the manufacturer to help ensure that the products are safe and fit for the intended use, and that they satisfy or exceed quality standards. After conducting a site examination in accordance with 21 CFR 820 requirements, the FDA will issue an FDA 483 form outlining any non-conformities that were found.
The 21 CFR Part 820 requirements for GMP are identical to the international standard ISO 13485. GMP is not certified, unlike ISO 13485 or CE Marking.
How can we assist you with our Medical Device compliance solutions?
A 510k is a premarket submission made to the FDA to show that the product being marketed is essentially equivalent—that is, at least as safe and effective—to a product already on the market legally and not requiring a PMA. Submissions must make and support their significant equivalency claims by comparing their products to one or more comparably priced, legally marketed products. The term “predicate” refers to the legally marketed device(s) to which equivalence is made. Our regulatory specialists can help you achieve certification with an incredible success rate.
In Vitro Diagnostic (IVD) Device Registration:
- Our experts will determine if your product is an IVD device.
- We will assist in completing and submitting the application form.
- We’ll help you on issues related to quality assurance and regulatory compliance.
- We will determine if your activities require an MDEL.
- We will help you obtain Health Canada approval.
- Our specialists will help you stay compliant with Health Canada’s medical device regulations.
Medical Device Establishment Registration & FURLS Certification:
- Identify the Appropriate Level of Regulatory Control.
- Gather Necessary Documentation and Documentation.
- Fill Out the Establishment Registration Application Form to Completion.
- Submit Completed Form and Supporting Documents & monitor application progress as it’s reviewed.
- As an owner or operator, having a valid login ID and password to access the FURLS is a must.
- As an owner or operator, you must obtain an annual registration.
- In case of official correspondent, owner or operators must create a separate sub-account for any communication.
- FDA has established FURLS to advance electronic submissions.
Software as a Medical Device (SaMD) Classification and Registration:
The first stage in our procedure entails classifying your device, and the second step involves classifying your SaMD’s risk according to the nation in which it was registered.
Once the class and risk categories have been established, a detailed dossier will be created in accordance with IEC 62304 guidelines. The medical device licensure application (if necessary) is ready for submission to Health Canada and/or the FDA once the technical dossier is finished.
How Quality Smart Solutions can help
Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license. We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification.
Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information: