USA – Legacy devices report highlights need for data to support future policies

More data is needed to understand the risks legacy connected medical devices pose to the healthcare system, particularly in their vulnerability to cyberattack. That...

USA – FDA offers guidance on waiver requests for pH adjusters

The US Food and Drug Administration (FDA) has issued a draft guidance on its criteria for permitting the use of pH adjusters in parenteral, ophthalmic or...

USA – Content of Premarket Submissions for Device Software Functions

This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of...

USA – FDA drafts guidance on medical device voluntary improvement program

The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation in a permanent medical device Voluntary Improvement Program (VIP)...

USA – New guidances outline eSTAR submission requirements for de novo and 510(k) device...

The US Food and Drug Administration is one step closer to requiring electronic submission of all   premarket applications for both 510(k) and de novo...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – FDA device center guidance priority lists targets COVID, digital health

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published its FY2023 guidance priority lists. Much of the...
Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

USA – Diversity plan draft guidance on track before year end, FDA official says

The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take...

USA – FDA Clears First COVID-19 Home Antigen Test

Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home...
TGA Seeks to Support Software as a Medical Device, Develop Cybersecurity Guidance

USA – Guidance gives FDA authority to reject devices due to poor cybersecurity

While final guidance gives the US Food and Drug Administration (FDA) the authority to deny a new product application  the product’s cybersecurity measures don’t...
ANVISA: Nearly half of all Brazil GMP certificates now issued under Medical Device Single Audit Program

Brazil – Brazilian regulators update Good Manufacturing Practices for medical devices and IVDs

ANVISA, Brazil’s medical device market regulator, has issued a new resolution updating Brazilian Good Manufacturing Practices (BGMP) for devices as well as in vitro...

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