EVERBIZ News Center: company news, global medical device regulatory updates, and registration and compliance insights.
FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Guidance – Download
This resource is the US FDA (Food and Drug Administration) guidance for the pilot phase of the Accreditation Scheme for Conformity Assessment (ASCA). About this document Under ASCA, accredited testing laboratories issue test reports against FDA-recognised consensus standards. When a company submits a report from an ASCA-accredited laboratory, the FDA generally does not need to…
FDA ASCA Program: What Manufacturers Need to Know About Accredited Testing Laboratories
How the FDA ASCA program works, why the accreditation body matters, and what to check before relying on an ASCA test report.
US FDA De Novo (New Classification) Requests for Medical Devices
This article focuses on De Novo classification requests to the US FDA. The five most common FDA submission types are: Investigational Device Exemption (IDE), Premarket Notification (510(k)), Premarket Approval (PMA), De Novo requests and Humanitarian Device Exemption (HDE). The De Novo request provides a pathway to classify novel medical devices for which there is no…
US FDA Medical Device 510(k) Submissions
This article focuses on 510(k) submissions to the US FDA. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device, i.e. substantially equivalent (Section 513(i)(1)(A) of the Federal Food, Drug, and Cosmetic Act). Submitters compare their device…
FDA Accreditation Scheme for Conformity Assessment (ASCA) Program Guidance – Download
This resource is the US FDA (Food and Drug Administration) guidance for the Accreditation Scheme for Conformity Assessment (ASCA) after it moved from a pilot to a permanent program. About this document The guidance sets out how the permanent ASCA program operates: how accreditation bodies and testing laboratories obtain ASCA recognition, the requirements laboratories must…
FDA Guidance: The 510(k) Program: Evaluating Substantial Equivalence – Download
This resource is the US FDA (Food and Drug Administration) core guidance on determining “substantial equivalence” in 510(k) premarket notifications. About this document The guidance explains in detail the FDA’s decision-making process for determining whether a new device is substantially equivalent to a predicate device, including whether the intended use is the same, whether differences…
FDA Guidance: User Fees and Refunds for 510(k) Submissions – Download
This resource is the US FDA (Food and Drug Administration) guidance on paying user fees and obtaining refunds for 510(k) premarket notification submissions. About this document The guidance explains which 510(k) submissions require a user fee, when the fee must be paid, the reductions available with a Small Business Determination (SBD), and the conditions for…
FDA 510(k) Electronic Submission Template (eSTAR) Guidance – Download
This resource is the US FDA (Food and Drug Administration) guidance on the electronic submission template (eSTAR) for 510(k) submissions. Since 1 October 2023, 510(k) submissions must in principle be submitted electronically using eSTAR. About this document eSTAR is an interactive PDF submission template provided by the FDA. It guides companies through each section of…
FDA 510(k) Third Party Review Program Guidance – Download
This resource is the US FDA (Food and Drug Administration) guidance on the 510(k) Third Party Review Program. About this document Under this program, eligible devices can first be reviewed by an FDA-recognised third-party review organisation (3P510k Review Organization), with the FDA then making the final decision – usually faster than submitting directly to the…
Vietnam IMDA Medical Device Registration
This article focuses on Vietnam’s IMDA medical device registration rules and introduces the requirements for registering medical devices in Vietnam. 1. The Regulator From 1 January 2025, Vietnam formally transferred medical device management from the Department of Medical Equipment and Construction (DMEC) to the newly established Infrastructure and Medical Device Administration (IMDA). The official website…
Singapore HSA Medical Device Registration
In Singapore, medical devices are regulated by the Health Sciences Authority (HSA). Established in April 2001 under the Ministry of Health (MOH), the HSA is the statutory body responsible for regulating Western medicines, medical devices, complementary health products, cosmetics and other products. It has administrative enforcement powers as well as the independence and flexibility of…
Overview of FDA Medical Device Regulation
In the US, medical devices are regulated by the FDA’s Center for Devices and Radiological Health (CDRH), which is highly similar in its core premarket technical review function to China’s Center for Medical Device Evaluation (CMDE). For Chinese medical device companies wanting to export to the US, understanding the basic requirements of FDA device regulation…