Medical Devices Archives - Page 10 of 11

U.S. FDA Issues Draft Guidance on Special 510(k) Program

The U.S. Food and Drug Administration (FDA) has published a draft guidance intended to aid certain medical device manufacturers in retaining approval of previously authorized devices when making certain modific... Read More...

FDA Seeks Comment on Class 1 Accessories

The U.S. Food and Drug Administration (FDA) is seeking public comment on a proposed list of medical device accessory products that it believes are suitable for Class I classification. According to a Notifica... Read More...

U.S. FDA Seeking Input on Software Precertification Pilot Program

The U.S. Food and Drug Administration (FDA) is seeking public comment on an updated version of its proposed pilot program to speed the approval of software used in digital health applications.

U.S. FDA Releases Draft Guidance on Humanitarian Device Exemptions

The FDA has published a draft guidance to clarify its requirements and review practices in connection with medical device applications submitted under its Humanitarian Device Exemption (HDE) Program.

FDA Exempts Certain Class II Devices from Premarket Notification

The FDA has issued a Final Order that exempts certain Class II medical devices from the agency’s premarket notification (510(k)) requirements.

FDA Updates List of Recognized Standards

The FDA has published an updated list of recognized consensus standards that can used in support of premarket medical device reviews conducted by the agency.

IMDRF Issues Draft Guidances for Medical Devices

The International Medical Device Regulators Forum has recently issued drafts of two separate guidance documents that may be of interest to medical device manufacturers.

FDA Publishes Guidance on Clinical Data Used in Medical Device Applications

The FDA has published a guidance document intended to help manufacturers and developers of medical device applications understand and apply the agency’s new regulations regarding the acceptance of clinical data in support of requests for FDA approval.

More Modest Growth Expectations in 2018 for Medical Device Manufacturers

After a somewhat mixed performance in 2017, medical device manufacturers have scaled back their expectations for anticipated growth in 2018, according to a recent survey by The Emergo Group.

EpiPens Recalled Due to Defective Part

Meridian Medical Technologies, the manufacturer of Mylan’s EpiPen-brand of epinephrine auto-injectors, has announced a voluntary recall of selected EpiPen lots due to safety concerns. According to the compan... Read More...