RegDesk Blog

Safe Medical Devices Act (SMDA)

The Safe Medical Devices Act of 1990 (SMDA) is a federal law that requires manufacturers and user facilities and to report any adverse events associated with a medical device to the FDA. In 1997, the SMDA has renamed the FDA Modernization Act (FDAMA). This policy aimed to simplify the regulation...

Read More >

Brazilia’s ANVISA to Wipe Out Existing Backlogs

ANVISA, Brazil’s drug regulatory body, announced Wednesday at the RAPS’ Regulatory Convergence that more than 800 new and generic drug application backlogs would be eliminated by January 2019. This elimination would allow for a shift in focus on new projects that ANVISA plans on implementing in the future.  Raphael Sanches...

Read More >

FDA to Transition to ISO 13485

This week, the FDA’s Center for Devices and Radiological Health (CDRH) announced its plans to create new regulations that would blend together two leading approaches to auditing medical device quality management systems, 21 CFR Part 820 and ISO 13485. According to the organization, there is approximately a 95% overlap between...

Read More >

TGA Proposes Restriction on Pediatric Anesthetic

After a warning from the United States Food and Drug Administration (FDA) against using oral forms of anesthetic benzocaine in children under two for teething pain, Australia’s Therapeutic Goods Association (TGA) decided to take action. The FDA found that these oral forms have a decreased effect on the pain and...

Read More >

The Lowdown on Humanitarian Device Exemption

A rare disease is defined by the U.S. Food and Drug Administration as a disease or condition that affects less than 200,000 Americans. Because rare diseases occur in such small numbers of patients, gathering the amount of clinical data and evidence necessary to support the safety and effectiveness of a...

Read More >

MEB and Swissmedic Agree On Greater Collaboration

On September 11, 2018, a memorandum of understanding (MoU) was signed by the heads of Swissmedic and the Netherlands Medicines Evaluation Board (MEB).  This MoU allows for a better and more stable collaboration between these regulators of medicines and medical devices. The regulators comment that this agreement is pertinent “given...

Read More >

4 Ways RegDesk Is Different from Emergo

“So is RegDesk essentially a regulatory consulting firm?” Questions like these haunt everyone on the RegDesk team. More often than not, inquisitors are quick to slap the “consulting firm” label onto the RegDesk name when attempting to categorize the company. But the truth is RegDesk is a software company, not a consulting...

Read More >

National Evaluation System for Health Technology (NEST)

The National Evaluation System for health Technology (NEST) enhances the medical device postmarket surveillance system by better producing evidence for medical device assessment and regulatory decision-making.  According to the FDA, NEST “[leverages] real-world evidence and [applies] advanced analytics to data tailored to the unique data needs and innovation cycles of...

Read More >