Category Archives: Regulatory

FDA Issues Guidance Document on Use of ISO 10993-1

September 8, 2020 – The FDA issued a guidance document on September 4, 2020, on Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process”.  This document is available on the FDA’s website here. This guidance document, which supersedes the 2016 version of […]

Chemical Characterization Standard ISO 10993-18:2020 Publishes

January 19, 2020 – The updated version of ISO 10993-18, the standard covering the chemical characterization of the ISO 10993 biocompatibility standard for medical devices, has just published. The new version is available here. The ISO 10993 series applies to devices where the material or medical device has direct or indirect body contact, with ISO 10993-1 […]

ISO Publishes New Technical Standard: ISO/TS 21726:2019 Biological Evaluation of Medical Devices

The International Standards Organisation (ISO) recently published a new technical standard, ISO/TS 21726:2019 Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents.  The TTC is a recognized tool for evaluating the biological risks of impurities when they are present at low levels and […]

FDA Lists ISO 10993-1:2018 as a Recognized Consensus Standard

On January 14, 2019, the FDA announced recognition (partial) of ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. In the Supplementary Information Sheet (SIS), it was noted that the FDA does not recognize Table A.1 in Annex A of the standard as it is in […]

FDA Delays Implementation of Changes to “Intended Use”

On January 16, 2018, the FDA announced that the Agency will be delaying implementation of parts of its “intended use” rule due to concerns raised by the industry. The FDA issued a Federal Register notice, attached here after the link, explaining that the delay of implementation would be “until further notice” and referenced a number […]

Recent FDA Announcements – Accessories and Least Burdensome Provisions

There’s frequently a flurry of FDA announcement near the end of the year, and this year was no exception.  We wanted to highlight a couple of the more pertinent ones that may be of interest to our customers.  The summaries below link to some of the more interesting guidance documents recently released. In late December, […]

FDA Issues Guidance Document on 3D Printed Devices

On December 5, 2017, the FDA issued the final version of its guidance document for 3D printed devices.  The document “Technical Considerations for Additive Manufactured Medical Devices – Guidance for Industry and Food and Drug Administration Staff” is meant to outline the agency’s current thinking about devices made via these processes and will be supplemented by […]

FDA Issues New Guidance Documents, Notable Changes to Pre-Submission Process

The FDA has issued a number of guidance documents, primarily focused on the pre-submission process that medical device manufacturers use to improve the likelihood of success of a particular filing.  All of the guidance documents are commitments made as part of MDUFA IV.  A link to the announcement of these guidance documents is here.  iuvo […]

FDA Updates Guidance on Exempt Class II Devices

On July 11, 2017, the US FDA published a final list of Class II devices exempt from 510(k) Premarket Notification Requirements (82 FR 31976).  As mentioned previously here, in an effort to comply with the 21st Century Cures Act of 2016, the Agency originally issued a notice on March 14, 2017 in the Federal Register […]

FDA Opens Comments on Proposed Laboratory Accreditation Program

The FDA took the first step on the long road of launching a proposed new laboratory accreditation program this month – the Accreditation Scheme for Conformity Assessment (ASCA). In early April 2017, the US House and Senate committees released a bill to reauthorize the Medical Device User Fee Act (MDUFA IV). As part of the […]