Tag Archives: CDRH

CDRH Releases 2015 Guidance Document Agenda, Announces Retrospective Guidance Document Review

On January 9, FDA announced the availability of a website that includes two lists of guidance documents that the Center for Devices and Radiological Health (“CDRH” or the “Center”) plans to publish in Fiscal Year (“FY”) 2015.  The first is a list of draft and final guidance documents that the Agency “fully intends” to publish (the … 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On October 3, 2014, FDA announced in the Federal Register the availability of a draft guidance titled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and the availability of a companion draft guidance titled “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).”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 Focuses on Sex-Specific Data in Medical Device Clinical Trials

On August 22, 2014, FDA issued a final guidance addressing the collection and analysis of sex-specific data in medical device clinical trials, entitled “Evaluation of Sex-Specific Data in Medical Device Clinical Studies.”  The guidance outlines “FDA’s expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information.”  According to the guidance, studying both sexes … 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As previously highlighted, FDA recently notified Congress of its intent to issue two draft guidance documents proposing to implement a new regulatory framework for LDTs.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FDA Announces Intent to Issue Draft Guidance Documents Describing Regulatory Framework for Laboratory Developed Tests

In a major announcement, on July 31, FDA notified Congress of its intent to issue two draft guidance documents that, if finalized, would implement a new regulatory system for laboratory developed tests (LDTs).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 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

FDA Relaxes Regulation of Certain Software Devices

On June 20, 2014, FDA issued a draft guidance entitled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” informing manufacturers and others “that the Agency does not intend to enforce compliance with the regulatory controls” that apply to these three types of devices. Medical device data systems (MDDS), medical image … 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

FDA Finalizes Guidance on Design Considerations for Pivotal Clinical Investigations for Medical Devices

On November 7, 2013, FDA published its final guidance document on Design Considerations for Pivotal Clinical Investigations for Medical Devices.  The 57-page guidance finalizes a draft guidance issued by the agency on August 15, 2011.  The guidance “is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for … Continue Reading

FDA Releases Report on Agency’s Role in Development of Personalized Medicine Products

On October 29, FDA released a report entitled “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development.” As discussed previously on this blog, personalized medicine is a regulatory area that an FDA official has described as “chaotic” and that has ranked among the Center for Devices and Radiological … Continue Reading

FDA Enters Second Week of Government Shutdown

As FDA enters its second week of the federal government shutdown, almost half of the agency’s employees have been furloughed, with a skeletal team carrying out limited operations.  According to FDA’s website, these operations are limited to emergency work involving the safety of human life or the protection of property, criminal law enforcement work, and … 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

CDRH Issues Draft SOP for Level I, Immediately in Effect Guidance on Premarket Data Issues

Last week, FDA announced the availability of a draft standard operating procedure (Draft SOP) on CDRH’s process to quickly notify stakeholders when new scientific information changes CDRH’s expectations for the data required for premarket submissions, such as Investigational Device Exemption (IDE), Premarket Notification (510(k)), Premarket Approval (PMA), or Humanitarian Device Exemption (HDE) submissions.  The Draft … Continue Reading

FDA Announces Public Workshop to Discuss Ways to Incorporate Patient Perspectives Into the Medical Device Regulatory Process

FDA recently announced a public workshop to be held on September 18 – 19, 2013 on ways to incorporate patient perspectives on “meaningful benefits” and “acceptable risks” of new medical devices.  The meeting is intended to solicit stakeholder input to discuss ways to collect and validate patient preference information and to inform the use of … Continue Reading

FDA Issues Draft Guidance on Medical Device Reporting for Manufacturers

On July 9, 2013, FDA announced the availability of a draft guidance document titled “Medical Device Reporting for Manufacturers.”  Written in a question and answer format, the draft guidance provides FDA’s current views on FDA’s Medical Device Reporting (MDR) regulation, 21 C.F.R. part 803.  Once finalized, the draft guidance will supersede the agency’s previous 1997 … Continue Reading

FDA Proposes New Pre-Decisional IDE Program

Yesterday, we discussed a new draft guidance issued by FDA concerning IDE decisions.  While that post focused on FDA’s IDE decision-making process and the regulatory implications of those decisions, this post addresses a new program within CDRH—the Pre-Decisional IDE program—that FDA proposed in the draft guidance. To further help applicants reach their goal of device … Continue Reading

FDA Issues Draft Guidance on IDE Decisions and New Pre-Decisional IDE Program

On June 14, 2013, FDA issued a draft guidance, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations,” to clarify the regulatory implications of FDA’s IDE decisions and to propose a new program to facilitate trial designs in support of marketing approval or clearance. FDA may take three actions with respect to IDE applications: approval, … Continue Reading

FDA Finalizes CDRH Appeals Process Guidance, Issues Draft Guidance on Section 517A

On May 17, 2013, FDA took significant steps to update its appeals process for medical devices.  First, FDA finalized its guidance on CDRH Appeals Processes, which “describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees.”  Second, FDA issued a new draft guidance on Questions and Answers … Continue Reading

CDRH Releases Updated Plan to Strengthen Postmarket Surveillance of Medical Devices

On April 23rd, FDA’s Center for Devices and Radiological Health (CDRH) released a report entitled “Strengthening Our National System for Medical Device Postmarket Surveillance: Updates and Next Steps.”  This document updates the plan issued by CDRH in September 2012, which set out the agency’s initial steps to “develop and implement a comprehensive medical device postmarket … 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
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