Tag Archives: 510(k)

FDA Issues Final Guidance Establishing Framework for a Safety and Performance Based Pathway

On February 1, 2019, FDA issued a final guidance[1] establishing an optional 510(k) pathway for certain well understood devices. This “Safety and Performance Based Pathway,” an expansion of the longstanding Abbreviated 510(k) program, is part of FDA’s ongoing effort to modernize and strengthen the 510(k) program. The pathway will continue to require the identification of … Continue Reading

Letter to File or New 510(k)?: CDRH Finalizes Two Key Guidances

On October 25, 2017, FDA’s Center for Devices and Radiological Health (CDRH) issued two final guidance documents that provide FDA’s current thinking regarding whether a modification to a 510(k)-cleared device will require the submission of a new 510(k), or may be documented in a “letter to file” as part of the manufacturer’s quality system.  Such … Continue Reading

Recent Reports Claim Improvements in FDA’s Review of Medical Device Submissions

Two recent reports cite gains made by the Center for Devices and Radiological Health (CDRH) in strengthening the clinical trial enterprise and shortening the review times for marketing applications for medical devices.  The reports suggest that CDRH’s review processes are becoming more efficient, and that on average applicants can expect shorter review times for investigational … Continue Reading

FDA Issues Draft Guidance on Determining when Data from Foreign Clinical Studies Can Support Device Submissions

It is becoming increasingly common for medical device companies to conduct clinical studies outside the United States and then seek to use data from these foreign studies in regulatory submissions to FDA. In a draft guidance issued on April 22, 2015, FDA lays out the factors it considers when confronted with data from foreign studies … Continue Reading

FDA Proposal to Regulate LDTs Raises Legal Liability Questions for Labs

Back in August, we wrote about the FDA’s controversial plan to release draft guidance on a new regulatory framework for Laboratory Developed Tests (LDTs) —  diagnostic tests developed by and used within individual laboratories across the country.  As it stands now, LDTs are overseen by the Centers for Medicare and Medicaid Services under the Clinical … Continue Reading

21st Century Cures Discussion Draft Act Proposes Changes to Medical Device Regulation

A discussion draft of the highly anticipated legislation, the 21st Century Cures Act, was released on January 27, 2015 (Draft Act). The Draft Act includes proposals that stem from the 21st Century Cures Initiative that was launched in April 2014 by House Energy and Commerce (E&C) Committee. The Draft Act contains five titles that are … Continue Reading

FDA Issues Draft Guidance on 510(k) Transfers

In late December 2014, FDA published a draft guidance entitled, “Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers,” which provides information to industry on how to notify FDA of the transfer of a 510(k) clearance from one person to another.  The draft guidance also outlines procedures that FDA staff and industry should … Continue Reading

FDA Finalizes Appeals Guidance on Section 517A

On July 30, 2014, FDA issued a final guidance, “Center for Devices and Radiological Health Appeals Processes:  Questions and Answers About 517A,” which provides an interpretation of key terms for appeals of certain CDRH decisions under section 517A of the Food, Drug, and Cosmetic Act (FDCA), including what constitutes a “significant decision” and a “substantive … Continue Reading

FDA Finalizes Guidance on the Evaluation of 510(k) Substantial Equivalence

On July 28, 2014, FDA issued an important final guidance relating to the Agency’s substantive review of 510(k) notifications, entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].”  This guidance applies to the 510(k) review process for both diagnostic and therapeutic devices and is applicable to 510(k) reviews undertaken by the Center for … Continue Reading

FDA Issues Draft Guidance on Benefit-Risk Considerations

On July 15, 2014, FDA issued a draft guidance entitled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics,” which describes the benefit and risk factors that FDA may consider during the review process for a 510(k) submission (“draft guidance”).  This draft guidance applies to both diagnostic and … Continue Reading

Preemption applies to 510(k)-cleared components of a PMA-approved device

We frequently post about developments in medical device preemption.  Preemption doctrine is a key issue in medical device product liability cases, and often a powerful tool for medical device manufacturers defending product liability claims.  As a general matter, under preemption doctrine, devices approved by a premarket approval application (PMA) are exempt from common law claims … Continue Reading

Possible Implications of Mutual v. Bartlett for Design Defect Claims Involving 510(k) Devices

On June 24, 2013, the Supreme Court issued its opinion in Mutual Pharmaceutical Co., Inc. v. Bartlett, 570 U.S. __ (2013), holding that the plaintiff’s claim that the defendant’s generic prescription drug was defectively designed was impliedly preempted.  Although in the drug context, Bartlett may have implications for cases involving medical devices, particularly design defect … Continue Reading

Use of New Administrative Order Authority to Up-Classify Devices: Proposed Order on “Sunlamp Products” Offers Glimpse Into FDA’s Approach

On May 6, 2013, FDA issued a proposed order to reclassify ultraviolet (UV) lamps intended for tanning from class I devices (general controls) exempt from premarket notification to class II devices (special controls) subject to premarket notification.  FDA also proposed to change the focus of the classification regulation from “ultraviolet lamps” to “sunlamp products,” including … Continue Reading

D.C. District Court Rules FDA has Inherent Authority to Rescind 510(k) Clearance in “Rare Situation”

In a closely watched case, Ivy Sports Medicine v. Sebelius, et al., the United States District Court for the District of Columbia recently upheld FDA’s rescission of the clearance of ReGen Biologic’s 510(k) for the Menaflex Collagen Scaffold device (Ivy Sports Medicine is the successor in interest to ReGen).  The court held that FDA has … 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

Proposed FDA Rule Requires “Good Clinical Practice” in Foreign Device Studies and Extends GCP Requirements to All Studies Supporting Device Submissions

On February 25, 2013, FDA issued a proposed rule incorporating the principles of “Good Clinical Practice” (“GCP”) into the requirements for FDA acceptance of data from clinical studies conducted outside the United States, and extending such requirements to studies supporting all types of device submissions, for both U.S. and foreign studies.  Under the proposed rule, … 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

Summary of Four Recent FDA Warning Letters on Device Advertising/Promotion Activities Now Available

In November, the Office of Compliance (OC) in FDA’s Center for Devices and Radiological Health (CDRH) posted on its website four warning letters relating to the advertising and promotion of medical devices: Warning letter to Quanta Systems, S.p.A. re: Quanta Q-Plus (Q-Plus Series) and Light Series Laser models (October 18, 2012) Warning letter to NeuroMed Devices, Inc. … Continue Reading

Recent FDA Report Highlights Improvements to the 510(k) Process

FDA’s Center for Devices and Radiological Health (CDRH) recently issued a report describing progress on its efforts to strengthen and improve the 510(k) process.  The report noted that in the nearly two years since FDA launched its efforts to improve the 510(k) pathway, CDRH staff are reviewing 510(k) notifications faster and clearing a greater percentage … Continue Reading