Medical Device Submissions
US FDA 510 (k), PMA, De Novo
Regulatory Insight has extensive experience negotiating the optimal approach to obtaining market approval or clearance for a specific medical device or IVD with the U.S. Food and Drug Administration. This translates directly into cost savings and faster time to market for a company’s product(s).
FDA classifies medical devices in the United States as Class I, II or III. However, it is far more complicated than that. Most Class I devices are 510(k)-exempt, but not all. Most Class II devices require a 510(k), but some are 510(k)-exempt. Some Class III devices require a PMA and some only require a 510(k).
Novel devices are often classified by the FDA as Class III simply because there is no predicate device. However, Section 513(f) of the Food, Drug and Cosmetic Act allows the sponsor of a novel device to submit a de novo application for potential reclassification of their novel Class III device to a Class I or II device, eliminating the need for a costly and time-consuming PMA.
We also prepare and submit Pre-Submissions (Pre-Subs), particularly in regard to PMAs and de novo applications in order to gain concurrence from the FDA on the regulatory strategy and contents of the applications.
Regulatory Insight specializes in the following types of U.S. FDA regulatory submissions:
510(k)s Premarket Notifications (including Abbreviated 510(k)s & Special 510(k)s)
PMA Premarket Approval Applications (including PMA Supplements)
De Novo Applications
Establishment Registrations and Device Listings
Product Reports for Radiation Health
513(g) Requests for Classification Information
Q-Subs / Pre-Subs
RFD Requests for Designation Submissions to the Office of Combination Products
Health Canada Medical Device License, Establishment License
Under Health Canada’s Medical Device Regulations, all manufacturers of Class II, III and IV medical devices imported or sold in Canada must first obtain a Medical Device License.
Manufacturers wishing to obtain a Medical Device License for distributing their devices in Canada must first attain an MDSAP (Medical Device Single Audit Program) Certificate from a Health Canada recognized Auditing Organization.
In most cases, someone who imports into Canada, or sells in Canada, a medical device for human use requires a Medical Device Establishment License. Manufacturers of Class I medical devices who sell those devices solely to the ultimate consumer are also required to obtain a Medical Device Establishment License.
Regulatory Insight has obtained numerous Medical Device Licenses and Medical Device Establishment Licenses for its clients and can assist your company to obtain the same. Regulatory Insight can also help your company establish its quality system to be in full compliance with MDSAP and can recommend an Auditing Organization for issuance of your Quality System Certificate.
European CE Mark, Technical File, Design Dossier
Marketing your medical devices in Europe requires that you first obtain the CE mark for those devices.
Medical Devices are regulated in Europe under Regulation (EU) 2017/745 as Class I, IIa, IIb and III devices. Generally, this requires the establishment of a Technical File. In addition, your company must obtain a Quality System Certificate, such as the ISO 13485 Quality System Certificate from a Notified Body.
Manufacturers of IVDs must follow the Regulation (EU) 2017/746.
Regulatory Insight has guided many companies through each of the above Directives and Certifications to obtain the CE mark for their medical devices and IVDs. We would be delighted to assist your company with this process as well.
Australian TGA Device Approval Applications
In order to import, manufacture, distribute and sell medical devices in Australia, regulatory approval must first be obtained from the Therapeutic Goods Administration (TGA) by applying to have the medical device included in the Australian Register of Therapeutic Goods (ARTG).
Regulatory Insight has assisted several companies to obtain regulatory approval from the TGA. We would welcome the opportunity to help your company gain TGA approval for your medical devices as well.