Nasdaq

InnerScope Hearing Technologies (OTC: INND) Completes FDA Class II Medical Device Registration for its Hearing Aid Devices

InnerScope has completed the FDA Medical Device Registration for Class II Hearing Aid, Air Conduction with Wireless Technology, and is preparing for the Launch of its Latest in Direct-to-Consumer ...
JD Supra

Not Worth the Paper It’s Printed On: FDA Calls Companies to Stop Issuing Misleading Medical Device Establishment Registration Certificates

At the beginning of the COVID-19 pandemic, we saw what seemed to be a surplus of “FDA Registration Certificates” being presented by Chinese manufacturers of face masks and other personal protective ...
Yahoo Finance

FDA Approval Process for Medical Devices | 2-Day Online Training Course (Dec 2nd-3rd, 2025) with 12 CPD Hours | 510(k), IDE, PMA, HDE, and De Novo Demystified

Dublin, Sept. 23, 2025 (GLOBE NEWSWIRE) -- The "FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course (Dec 2nd-3rd, 2025)" has been added to ResearchAndMarkets.com's ...
WOOD-TV

iFabric Corp. Receives FDA Medical Device Registration for Apparel Products Utilizing Multiple Textile Technologies

MARKHAM, ON / ACCESSWIRE / April 30, 2024 / iFabric Corp. ("iFabric" or the "Company") (TSX:IFA.TO)(OTCQX:IFABF), a leading provider of innovative apparel and textile technologies, announces its ...
JD Supra

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance ...
FierceBiotech

FDA seeks input on regulating 3D-printed implants, devices made at the point of care

The FDA has begun outlining a potential approach for regulating a cutting-edge front emerging in healthcare: the 3D printing of medical implants or devices customized for each individual patient and ...
Medical Device Network on MSN

FDA’s UDI guidance ‘ambiguity’ could lead to inconsistent implementation

The perceived ambiguity of the US Food and Drug Administration’s (FDA) guidance on Unique Device Identifier (UDI) ...
Yale Environment 360

Loophole enables FDA approval of unsafe medical devices, Yale study finds

Manufacturers, through a loophole in federal law, can use an unsafe medical device as a basis for authorization by the U.S. Food and Drug Administration (FDA) to bring new, related products to market, ...