Standards & Standards Development

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...

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...

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...

Now that the Centers for Medicare and Medicaid Services (CMS) has published its long-awaited final rule implementing the Physician Payments Sunshine Act (Federal Register, February 8, 2013), medical device manufacturers can move forward to carry out a familiar task: complying with regulations.

Since it was established 11 years ago, the Stanford Biodesign Innovation Program has led to more than 200 patents and 24 start-up companies, including Spiracur, the company behind the SNaP Wound Care System (featured in the January issue of Medical Design Briefs). This intensive one-year program helps...

The IEC 62304 standard for medical device software is causing system engineers worldwide to step back and examine their software development methods with considerable scrutiny. Although at one time, software development and testing was an integral part of overall system design and...