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  • Regulatory NewsRegulatory News

    FDA Device Approvals Speedy in First Half of 2014, With Even Faster Approvals Coming Soon

    The US Food and Drug Administration (FDA) approved new medical device products at a pace nearly twice that of the year prior, according to a new report just published by analysts at EP Vantage, the market intelligence branch of Evaluate. New Report EP Vantage's half-year report looked at all medical devices approved by FDA through its Premarket Approval (PMA) pathway and its Humanitarian Device Exemption (HDE) pathway —both used almost exclusively by entirely new devic...
  • 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...
  • Regulatory NewsRegulatory News

    CDRH Finalizes Appeals Process Guidance, Adding New 'Significant Decision' Category

    The US Food and Drug Administration (FDA) this week released a final version of a guidance on the Center for Devices and Radiological Health's (CDRH) appeals process. Background The 2013 passage of the Food and Drug Administration Safety and Innovation Act ( FDASIA ) instituted a new provision under Section 603 of the act intended to overhaul how FDA's medical device regulatory division, CDRH, handles appeals. Section 603 amended Section 517A of the Federal Food...
  • Regulatory NewsRegulatory News

    CDRH Sees Customer Satisfaction as a Driver of Innovation, Good Regulation

    The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) device regulatory branch, has a question for industry: How have we helped you lately? Background It's a bit of an odd question without context. In February 2014, CDRH launched a new document, CDRH 2014-2015 Strategic Priorities , in which it said the device center would be focusing on three things in 2014: strengthening clinical trials, balancing pre- and post-mark...
  • Regulatory NewsRegulatory News

    FDA's Device Division Looking for New Leader for Regulatory Policy

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is looking for a new deputy center director for policy, the top policy position within the center, it announced this week. The candidate would help lead the development, implementation and evaluation of the medical device regulatory center's regulatory policies and programs, including guidance documents and regulations, FDA said in the notice. The position is also tasked w...
  • Regulatory NewsRegulatory News

    FDA Moves Three Device Types into Class II Special Controls

    The US Food and Drug Administration (FDA) has proposed classifying three types of medical device products into its Class II regulatory controls scheme, subjecting them to special controls meant to ensure their efficacy, safety and quality. Background In the US, medical devices are regulated by FDA's Center for Devices and Radiological Health (CDRH) and subject to three general classifications: Class I (for low-risk devices), Class II (moderate risk) and Class III (high ...
  • Regulatory NewsRegulatory News

    Final Rule Seeks More Stringent Regulation of Tanning Lamps

    The US Food and Drug Administration (FDA) has issued a final rule which will regulate ultraviolet lamps used for tanning more stringently, reflecting the lamps' association with skyrocketing rates of skin cancer. Background At present, sunlamp products—commonly used in tanning beds—are Class I medical devices that are exempt from premarket review procedures. The devices have been marketed since before the 1976  Medical Device Amendments , which effectively regulated me...
  • Regulatory NewsRegulatory News

    FDA Proposes Strengthening Requirements for Rapid Flu Tests

    US Food and Drug Administration (FDA) regulators are proposing to reclassify some Influenza Antigen Detection Test Systems into a higher-risk category than the systems now inhabit, citing potential for the devices to fail to detect newer versions of the virus. Background The devices, which are used to detect the presence of influenza in a clinical sample, were Classified as low-risk Class I medical devices in 1982. Class I devices only require the company to adhere to g...
  • Regulatory NewsRegulatory News

    FDA Down-Classifies Colon, Intravascular Devices

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has proposed that two medical devices marketed prior to the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act) be subject to less stringent regulation. In two separate Federal Register announcements, FDA said it would permit intravascular administration sets and colon capsule imaging systems, respectively, to be classified as Class II devi...
  • CDRH Releases New Learning Module on ISO 13485:2003

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new set of learning modules Friday on voluntary audit report submissions and how to utilize CDRH's new pilot program . The learning section consists of an introductory video and five learning modules in both English and French. The modules cover the following topics: GD211 - Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma GD211 - Module 1...