USFDA
US FDA Submissions like 510(k), IDE, PMA, DeNovo regulates the sale of medical device in the US. The Centre for Device and Radiological Health (CDRH) is responsible for regulatory activities such as import/export medical device from Manufactures, Re-labellers, Re-packagers, contract manufactures etc, in the US. The FDA regulates the medical device as class I, II and III. The regulatory pathway can be decided according to the risk classification of device. Pre market notification otherwise known as 510(k) is applicable for most of the class II and some of the class I devices. Most of the low risk Class I devices are exempted from premarket notification and Class III high risk devices required Premarket Approval (PMA).
Establishment Registration and Device Listing
All the device categories are required to register their establishment with FDA and listing of medical devices. This is applicable for all Manufactures, Distributers, Importers of both domestic and foreign origin who intend to sell their medical devices in the US.
We assist companies to prepare 510(k) submission, which is a premarket notification required by U.S. Food and Drug Administration (FDA) for certain medical devices. We provide the following services to obtain 510(k) clearance.
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Regulatory expertise in understanding FDA requirements
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Classification and identification of predicate devices
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Submission Strategy- Traditional, Abbreviated and Special
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Interpretation of guidance documents
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E-STAR documentation preparation and document organisation
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Communication with FDA and response to FDA inquiries
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Post-submission Support- Product listing and Establishment Registration
Also known as Q-Submission which allow a manufacturer to effectively communicate with FDA to get feedback before the actual submission of premarket notification. Sponsors may request a formal meeting as part of the pre-submission process to discuss their questions with the FDA in more detail. The FDA provides feedback and recommendations based on the information provided in the pre-submission package. The goal of the Pre-Submission Program is to improve the efficiency of the regulatory review process by facilitating early communication between sponsors and the FDA.
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing approval.