North America

Combination Products Get Extra Year for Postmarket Compliance

The FDA gave sponsors of combination drug/device products another year to get their IT affairs in order before complying with new postmarket safety reporting requirements. Read More

CDRH Offers Draft Guidance on Nitinol Medical Devices

CDRH has issued draft guidance for sponsors of devices containing nitinol that specifies what information should be included in their premarket submissions. Read More

FDA Addresses Safety Concerns for Surgical Staplers and Staples

The FDA issued a draft guidance and proposed order designed to ensure the safe and effective use of surgical staplers and staples for internal use, following concerns the agency identified in medical device reports. Read More

FDA Clarifies Labeling Identifier Rules for Convenience Kits

The FDA considers first aid and other “convenience” kits a single device for regulatory purposes, the agency said in final guidance. Read More

FDA Urged to Clarify Voluntary Quality Standards for Combination Products

A trade group representing hybrid drug- and device-makers is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards. Read More

CDRH Flags Ongoing Concerns Over Contaminated Duodenoscopes

CDRH Director Jeff Shuren said the center is considering regulatory actions because of ongoing concerns over contaminated duodenoscopes. Read More

LC Medical Warned Over Validations for Wound Therapy Kits

LC Medical Concepts’ sterilization operations were not adequately validated to demonstrate sterility of its wound therapy kits, an Oct. 16-23, 2018, FDA inspection of the devicemaker’s Rochester, New York, facility revealed. Read More

FDA Issues List of Class 1 Accessories

The FDA has finalized a list of accessories that can be classified as Class 1 devices. The listing was required under the FDA Reauthorization Act of 2017. Read More

Documentation Failures Plague Hyperbaric Technologies

Failure to document numerous activities including validation, corrective and preventive actions, process changes and others landed Hyperbaric Technologies a Form 483 following a Sept. 19-26, 2018, inspection of its Amsterdam, New York, manufacturing facility. Read More

Specification Developer Fails to Submit MDR Reports

Specification developer Circulatory Technology failed to submit medical device reports within 30 days of receiving complaints that its Better Bladder device failed during use, collapsing as a result of leaks, an Aug. 22 to Sept. 26, 2018 FDA inspection revealed. Read More