The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News
    TrackersTrackers

    The Essential List of Regulatory Authorities in Asia

    To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.   For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unc...
  • Feature ArticlesFeature Articles

    What is a Wearable Device? Lifestyle Device vs. Medical Device

    This article discusses how to determine when wearable lifestyle devices, referred to as fitness trackers, might be categorized as medical devices. In cases where fitness trackers are used in particular ways, their categorization as a medical device carries with it specific requirements for compliance to regulations. The article provides useful information to regulatory personnel in assessing how much compliance to the Health Insurance Privacy and Portability Act (HIPPA) ...
  • Regulatory NewsRegulatory News

    FDA Legislation Tracker

    Each year, legislators introduce dozens of pieces of legislation hoping to change how the US Food and Drug Administration (FDA) regulates pharmaceuticals, medical devices, biologics and dietary supplements. Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often. Can't find legislation you know exists...
  • Regulatory NewsRegulatory News
    TrackersTrackers

    The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech

    Let's face it: Finding regulatory information can be difficult. Maddeningly difficult. Anyone interested in finding information about the US Food and Drug Administration (FDA) needs to have an almost encyclopedic knowledge of the regulator's website to find relevant information, to say nothing of the dozens of other government websites which house regulatory information or non-governmental websites which make finding information easier. What if there were an easier way t...
  • Regulatory NewsRegulatory News

    New FDA Pilot Program Wants to Make Keeping Track of Device Submissions Simple

    A new early-stage pilot program quietly under development by the US Food and Drug Administration (FDA) hopes to make it easier for medical device companies to see how their device is progressing through the agency's regulatory processes, all at a glance. CDRH Submission Tracker Pilot The Center for Devices and Radiological Health's (CDRH) pilot program, known as the CDRH Submission Tracker pilot, is an attempt to allow companies large and small to have a better sense of...
  • Feature ArticlesFeature Articles

    A (Technologically Stunted) Ad/Promo Reviewer Looks at Techy Solutions to Regulatory Issues

    I thought I was technologically savvy; at any given moment, I was juggling an iPhone, laptop, Blackberry, Kindle, iPad and who knows what other piece of technology I didn't actually need. Then, to my surprise, I encountered other "popular" forms of technology of which I was completely unaware. For instance, when interviewing potential candidates at a recent conference, I was handed business cards printed on the back with little boxes containing Rorschach-like images. Afte...