Christina Kuhn

Christina Kuhn

Christina Kuhn provides pharmaceutical and medical device companies advice on a variety of federal and state regulatory matters.

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FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies.  These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device.  In parallel, FDA also updated four previously final guidance documents to ensure … Continue Reading

FDA Publishes Draft Guidance on Investigational IVDs Used in Therapeutic Product Clinical Trials

On December 18, 2017, FDA announced the availability of a new draft guidance, titled “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.”  The draft guidance is intended to inform both product sponsors and IRBs regarding the application of the Investigational Device Exemption (IDE) regulation to investigational in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

FDA Issues Draft Guidances Outlining Digital Health and Decision Support Software Regulatory Approaches

FDA has described its evolving approach to regulating digital health and decision support software in two new draft guidance documents:  Clinical and Patient Decision Support Software and Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.  These draft guidances announce the agency’s initial interpretation of the health software … Continue Reading

FDARA Reauthorizes Device User Fees and Amends Key Device Provisions of FDCA

Last month, President Trump signed the FDA Reauthorization Act of 2017 (FDARA).  FDARA reauthorizes the Medical Device User Fee Amendments (MDUFA), allowing FDA to collect medical device user fees for fiscal years 2018 to 2022 after FDA’s current user fee authority ends on September 30, 2017.  Notably, the reauthorized MDUFA adds a substantial new user … Continue Reading

FDA Releases Digital Health Innovation Action Plan and Initiates Software Pre-Certification Pilot Program

In two new posts on the Covington Digital Health blog we analyze the Digital Health Innovation Action Plan recently released by FDA and the agency’s new software pre-certification (Pre-Cert) pilot program. The Digital Health Innovation Action Plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes and modernizing [the agency’s] … 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

LDT Update: FDA and CMS Testify Before the House Energy & Commerce Subcommittee Following Year of Debate on Oversight of LDTs

On November 17, 2015, the House Energy & Commerce Subcommittee on Health held a hearing examining the regulation of laboratory developed tests (LDTs).  CMS Deputy Administrator Patrick Conway and CDRH Director Jeffrey Shuren testified regarding the respective roles of CMS and FDA in the oversight of LDTs. The day before the hearing, FDA issued a … Continue Reading

FDA’s Office of Planning Issues Report on Review Process for Combination Products

The pace and process used by FDA for the review of combination products has been the subject of considerable concern by many device companies.  On October 14, 2015, FDA’s Office of Planning issued a report summarizing a study of the intercenter consultation process for the agency’s review of combination products.  The report identifies several challenges … Continue Reading

Bill Introduced to Streamline and Clarify Combination Product Regulatory Process

Sen. Johnny Isakson (R-Ga.) introduced a bi-partisan bill (S. 1767) on July 15, 2015, to help streamline and clarify the FDA regulatory process for combination products.  Co-sponsored by Sens. Robert Casey (D-Pa.) and Pat Roberts (R-Kan.), the “Combination Product Regulatory Fairness Act of 2015” is, according to Roberts, intended to “clarify the regulatory process for … Continue Reading

FDA Finalizes Guidance Limiting Oversight of Certain Software Devices

On February 9, 2015, FDA issued a final guidance document “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” in which the agency finalized a deregulatory policy for certain software devices.  FDA’s new guidance document largely confirms the enforcement policies set forth in the draft guidance document FDA issued in July … 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 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

FDA to Reorganize its Device Compliance Office with Increased Focus on Oversight of Advertising, Promotion, and Premarket Requirements

FDA recently announced that it is planning to reorganize the Office of Compliance within the Center for Devices and Radiological Health.  The changes will become effective in mid-November. The Office of Compliance plans to move “from a product-based structure  . . . to a function-based structure.”  At the moment, the Division of Enforcement A and Division … Continue Reading

FDA Finalizes Guidance on Financial Disclosures by Clinical Investigators

FDA issued a final guidance on disclosure of financial interests of clinical investigators.  FDA intends for the guidance to assist clinical investigators, clinical trial sponsors, and applicants in complying with 21 C.F.R. Part 54.  The guidance finalized and revised a draft guidance issued May 2011 and replaces a prior guidance issued in 2001. Under the … Continue Reading

Metal-on-Metal Hip Implants: FDA Proposes to Require Premarket Approval

On January 18, 2013, FDA issued a proposed order that would require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for metal-on-metal hip joint implants. Metal-on-metal hip replacement implants were marketed prior to the Medical Device Amendments of 1976, which gave FDA authority over medical … Continue Reading

Home Use Devices Draft Guidance Issued by FDA

FDA released a draft guidance Design Considerations for Devices Intended for Home Use on December 12.  The guidance provides design and development recommendations for minimizing the risks associated with home use devices. Home use devices are devices used outside of professional healthcare facilities.  Examples of home use devices include infusion pumps, cold packs, heart monitors, … Continue Reading

Unique Device Identifier Implementation Timeframe Amended

On November 19 FDA announced that it was amending its proposed rule to establish unique device identifier (UDI) requirements.  The amendments are necessary to comply with implementation deadlines of the Food and Drug Administration Safety and Innovation Act (FDASIA), which was enacted the day before FDA published the proposed rule in July 2012. FDA had … Continue Reading

Unique Device Identifier Rule Moves Forward as Comment Period Comes to Close

In July, FDA issued a much-anticipated proposed rule to implement a unique device identifier (UDI) system (for a summary of the proposed rule see our earlier Advisory).  As the period for public comment on the proposed rule comes to a close on November 7, the comments provide insight into aspects of the rule that FDA … Continue Reading