Tag Archives: In Vitro Diagnostics

FDA Publishes Draft Guidance on Investigational IVDs Used in Therapeutic Product Clinical Trials

On December 18, 2017, FDA announced the availability of a new draft guidance, titled “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.”  The draft guidance is intended to inform both product sponsors and IRBs regarding the application of the Investigational Device Exemption (IDE) regulation to investigational in vitro diagnostic devices (IVDs) used in therapeutic … Continue Reading

House Discussion Draft Released on Regulatory Approach for In Vitro Clinical Tests

On March 20, 2017, Rep. Larry Bucshon (R-IN) and Rep. Diana DeGette (D-CO) released a discussion draft of the Diagnostic Accuracy and Innovation Act (DAIA).  DAIA would regulate “in vitro clinical tests,” defined in the discussion draft as a “laboratory test protocol or finished product” intended for clinical use “in the collection, preparation, analysis, or … Continue Reading

FDA Publishes Draft Guidance on Codevelopment of Companion Diagnostics

FDA recently published a draft guidance document titled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.”  A companion diagnostic is an in vitro diagnostic device that provides “information that is essential for the safe and effective use of a corresponding therapeutic product.”  The new draft guidance is intended by … Continue Reading

CDRH Schedules Next Generation Sequencing Workshops

CDRH has scheduled two next generation sequencing (NGS) workshops on November 12 and 13, 2015 (see here and here for the Federal Register announcements) to further advance the conversation with stakeholders on the Agency’s development of new regulatory strategies for NGS-based clinical tests.  These workshops will build upon a discussion paper published in December 2014, … Continue Reading

FDA Is Exploring Options for Regulating Next Generation Sequencing Diagnostic Tests

On December 29, 2014, FDA issued a public workshop notice and associated discussion paper entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests–Preliminary Discussion Paper.”  The Discussion Paper describes opportunities and regulatory challenges presented by next-generation sequencing (NGS) tests, and requests public comment on possible new approaches to demonstrating analytical performance and clinical … Continue Reading

FDA Publishes Draft Guidances on Regulatory Framework for Laboratory Developed Tests for Public Comment

On October 3, 2014, FDA announced in the Federal Register the availability of a draft guidance titled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and the availability of a companion draft guidance titled “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).”  The draft guidances, if finalized, would implement a new … Continue Reading

FDA’s Announced Framework for Regulating Laboratory Developed Tests (LDTs) Leaves Open Many Questions

As previously highlighted, FDA recently notified Congress of its intent to issue two draft guidance documents proposing to implement a new regulatory framework for LDTs. Our recent e-Alert provides a detailed analysis of the proposed framework described in the two  documents FDA provided to Congress.  The drafts describe a risk-based and phased-in approach to applying … Continue Reading

FDA Releases Final Guidance Concerning In Vitro Companion Diagnostic Devices

On July 31, 2014, the Food and Drug Administration (FDA) released a final guidance entitled “In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff” (the Final Guidance). The Final Guidance explains FDA’s views on development, review, and authorization of in vitro diagnostic (IVD) devices that provide essential information for the … Continue Reading

FDA Announces Intent to Issue Draft Guidance Documents Describing Regulatory Framework for Laboratory Developed Tests

In a major announcement, on July 31, FDA notified Congress of its intent to issue two draft guidance documents that, if finalized, would implement a new regulatory system for laboratory developed tests (LDTs).  These guidance documents have been anticipated for several years, with the agency announcing over four years ago that it intended to change … Continue Reading

CFDA Announces “Five Rectifications Campaign” Targeting Medical Devices

On March 13, 2014, the China Food and Drug Administration (CFDA) announced the Five Rectifications Campaign, a special five-month enforcement campaign targeting medical devices. The Campaign will focus on medical device registration, manufacturing, distribution, advertising, and use in healthcare institutions.  The campaign began on March 15, 2014 and will end on August 15, 2014.… Continue Reading

FDA Issues Final Guidance Regarding Research Use Only and Investigational Use Only Products

On November 25, 2013, FDA issued a final guidance on research use only (RUO) and investigational use only (IUO) products.  FDA describes RUO products as devices in the laboratory phase of development and IUO products as devices in the product testing phase of development.  RUO products also may be offered and promoted for non-clinical purposes, … Continue Reading

Lab Association Petition Challenges FDA’s Authority To Regulate LDTs Under the FDCA

The American Clinical Laboratory Association (ACLA) filed a citizen petition on June 4 challenging Food and Drug Administration (FDA) authority to regulate laboratory developed tests (LDTs) as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA).  ACLA’s petition requests that FDA refrain from promulgating any draft or final guidance or rule purporting to regulate … Continue Reading

FDA Issues Draft Guidance on Molecular Diagnostic Instruments with “Combined Functions” That Reflects Regulatory Creep

On April 9, 2013, FDA published a Federal Register notice announcing a new draft guidance on molecular diagnostic instruments with “combined functions” — i.e., combining functions subject to FDA approval or clearance as well as functions not subject to FDA approval or clearance (such as research use only (RUO)).  The draft guidance has significant implications … Continue Reading

“Notified Bodies” Under EU Device Regulations: Under Stricter Control But With More Power

Unlike in the US, medical devices in the EU are not subject to a premarket authorization by a competent authority but instead to a conformity assessment procedure.  For low-risk devices, the manufacturer conducts this conformity assessment procedure, whereas for medium and high risk devices, independent third parties, so-called “Notified Bodies,” are involved. What are Notified … Continue Reading

Proposed EU Rules Impact Commercial Testing Laboratories

The European Commission has proposed a revision to the regulatory framework for in vitro diagnostic medical devices (IVDs) that could have a significant impact on the operations of commercial laboratories in the EU or those offering testing services to customers in the EU. Laboratory-Developed Tests Under current EU rules, laboratory-developed tests (colloquially known as “home … Continue Reading