• Regulatory NewsRegulatory News

    New Report Compares FDA Quality System Requirements With ISO 13485:2016

    The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for the revision of 21 CFR 820 (also known as the quality system regulation), which will harmonize with ISO 13485:2016 later this year. The most recent regulatory agenda says that sometime this month the US Food and Drug Administration (FDA) will issue a proposed rulemaking on the harmonization and moderniz...
  • In Unusual One-Two Punch, FDA Follows 'Extensive' Warning Letter With Safety Communication

    A Warning Letter to medical device manufacturer Shasta Technologies has highlighted major alleged deficiencies at the company's Sherwood, Ore., manufacturing facility, resulting in an unusual warning about the company's blood glucose testing supplies. Warning Letter According to the Warning Letter, inspectors from the US Food and Drug Administration (FDA) found serious problems during a December 2013 inspection of the Sherwood facility. For example, FDA said when its i...
  • Long-Sought-After Rule on CGMPs for Combination Products Released by FDA

    • 22 January 2013
    The US Food and Drug Administration's (FDA) Office of Combination Products (OCP) has released a new final regulation on the current good manufacturing practices (cGMPs) used in the manufacture of combination products. Background Combination products are, as their name implies, a combination of two or more product classes, such as a medical device, biologic and a pharmaceutical product. They are typically regulated by analyzing their constituent parts to determine thei...
  • FDA Releases Draft Guidance on Design of Home Use Medical Devices

    The US Food and Drug Administration (FDA) has released a new medical device draft guidance intended to assist manufacturers in designing and developing devices used by a patient in their own home-so-called "home use" devices. The devices covered include infusion pumps, cold packs, oxygen supplies, CPAP machines, wheelchairs, walkers and more. As defined by FDA, they are any device capable of being used outside of a professional healthcare facility or clinical laboratory....
  • FDA Looking to Overhaul Compliance Approach

    The US Food and Drug Administration (FDA) is headed toward a marked change in compliance policy in the coming years as the result of rapidly surging imports of pharmaceutical, medical device and biologics products, according to Mark Roh, regional food and drug director for FDA's Pacific Region. Under the new system, stand-alone compliance issues would become secondary in importance to quality systems put in place by companies. The Need for Change In a presentation to th...
  • Feature ArticlesFeature Articles

    Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices

    This article reviews the current state of the development of quality system requirements for combination products, in particular prefilled drug delivery devices. As part of a series on US Food and Drug Administration (FDA) regulation of combination products, 1-9 it discusses industry's response to FDA's proposed rule on quality systems for combination products and how manufacturers of combination products should prepare for compliance with the anticipated final rule and ...
  • Warning Letter Analysis: Device Companies, Tissue Bank Hit Hard for Deficiencies

    • 30 May 2012
    The US Food and Drug Administration's (FDA) newest batch of warning letters was released on 29 May 2012, and some familiar faces have come under further scrutiny. Medical device manufacturer McNeil PPC, a subsidiary of Johnson & Johnson, was hit with a lengthy list of claims by FDA, which said the firm is manufacturing no fewer than ten adulterated products. Three of the company's Pennsylvania facilities are currently the subject of an FDA consent decree after the...
  • Warning Letter Analysis: FDA Asks for Notification of Impending Drug Shortages in Newest Citations

    • 23 May 2012
    The US Food and Drug Administration (FDA) released a new batch of warning letters on 23 May, citing two pharmaceutical manufacturers and two medical device manufacturers for a series of regulatory infractions including current good manufacturing practice (CGMP) deficiencies, adulterated products, quality system regulation deficiencies and sterility issues. In a new development, FDA is also asking for companies served with warning letters to keep in informed about future ...
  • Company Cited for Failure to Follow Numerous Medical Device cGMP Regulations

    • 25 April 2012
    A warning letter released to the public 23 April cites medical device manufacturer Ad-Tech Medical Instrument Corporation for failure to follow medical device regulations established by the US Food and Drug Administration (FDA). The company, which manufactures devices for neurological monitoring and neurosurgery, was hit with a bevy of regulatory citations by FDA, which noted  the company's products were "not in conformity with the Current Good Manufacturing Practic...