FDA/​Regulatory

Health Canada, the Canadian medical device market regulator, is set to require all reprocessed single-use medical devices to Canadian Medical Device Regulations (CMDR) by September 1, 2015. According to MEDEC, the national association created for the Canadian medical technology...

The FDA recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes, which requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology...

A final guidance, “Design Considerations for Devices Intended for Home Use,” issued by the FDA, is intended to assist manufacturers in designing and developing home-use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements.

Scientists at the National Institute of Standards and Technology, Gaithersburg, MD, in collaboration with the National Cancer Institute and the Radiological Society of North America, have designed and developed image-calibration technology to study the effects of traumatic brain injury (TBI). The...

To strengthen the safety of medical devices, the FDA has finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. On October 1, the agency issued a final guidance on the content of premarket submissions for the management of...

On August 13, The FDA issued a guidance for industry and FDA staff called “Unique Device Identification System: Small Entity Compliance Guide”. This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA’s September...

The U.S. Food and Drug Administration has issued new draft guidance that would exempt certain Class I and Class II medical devices from premarket, or 510(k),submission requirements. If a device is “exempted from premarket notification,” then the FDA would allow a device that was...

UL (Underwriters Laboratories), Northbrook, IL, announced that the FDA has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 - Standard for Household and Commercial...

Recognizing that the need for effective cybersecurity to ensure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information, the FDA has issued a draft...

The U.S. Food & Drug Administration (FDA) has issued the first phase of its Global Unique Device Identification Database (GUDID): Guidance for Industry on June 11, 2014. To quickly provide industry with information critical to successful use of the GUDID, the FDA is issuing the GUDID Guidance in two...

The FDA has recently issued a draft guidance titled, "Humanitarian Device Exemption (HDE): Questions and Answers." This draft guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and the Humanitarian Device Exemption (HDE) authorized under section 520(m) of the...

Medical devices are not always one size fits all, especially with regard to child-sized devices. The Philadelphia Regional Pediatric Medical Device Consortium (PPDC) brings together engineers and biomedical researchers from the Children’s Hospital of Philadelphia (CHOP), Drexel...

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), West Conshohocken, PA, has proposed a new international standard to be used in the design, development, quality control, and comparison of a variety of collagen-based medical products, including surgical implants, delivery...

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), West Conshohocken, PA, has proposed a new international standard to be used in the design, development, quality control, and comparison of a variety of collagen-based medical products, including surgical...

The American National Standards Institute (ANSI) has launched the ANSI IBR Portal, an online tool for free, read-only access to voluntary consensus standards that have been incorporated by reference (IBR) into federal laws and regulations.

All interested parties are welcome to join in the development of a proposed new ASTM International standard that will provide guidance on how to conduct axial, bending, and torsional fatigue testing of stents. The proposed new standard, ASTM WK23330, Guide for in vitro Axial, Bending and...

Today, the FDA issued its final rule on the unique device identification (UDI) system that, once implemented, will provide a consistent way to identify medical devices. The UDI system should improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more...

The FDA Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Center for Biologics Evaluation and Research issued a Guidance document on “Radio Frequency Wireless Technology in Medical Devices” containing recommendations to assist industry and...