Tag Archives: draft guidance

FDA Issues Discussion Paper on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop held in 2015 regarding the oversight of LDTs. The Discussion Paper does not represent final guidance. Rather, the Discussion Paper is the FDA’s “synthesis of all feedback” received, which the FDA hopes will “advance public discussion on future LDT oversight.” The Discussion Paper is not enforceable.

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FDA Issues Draft Guidance on Medical Device Cybersecurity

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers should monitor and address cybersecurity risks.  The Guidance is the latest manifestation of a federal agency weighing in on the continually growing concern caused by cybersecurity threats.  Suzanne Schwartz of the FDA’s Center for Devices and Radiological Health commented that the Guidance “will build on the FDA’s existing efforts to safeguard patients from cyber threats by recommending medical device manufacturers continue to monitor and address cybersecurity issues while their product is on the market.”

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Filed under FDA, FDA Draft Guidance, FDA Enforcement, Government Enforcement, Health Information Privacy, Medical Devices, Privacy and Security, Technology, Uncategorized

General Wellness Products: Will the FDA Regulate Your Medical App or Device?

FDA General Wellness Banner

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than products that present a low risk to users. Cooley recently collaborated with Worrell to develop the algorithm below to help companies determine whether their product may qualify as a general wellness product.

In its draft guidance, the FDA states that it will not regulate general wellness products that:
  1. Are intended only for general use, and
  2. Present a very low risk to users’ safety.

According to the FDA’s definition, a “general wellness product” has:

  1. An intended use that relates to maintaining or encouraging a general state of health or a healthy lifestyle, or
  2. An intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions, where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

In other words, if your product’s intended use is not limited to the above general wellness intended uses and it does not present a very low risk to users’ safety, the product is outside the FDA’s scope of guidance related to general wellness products.

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Filed under FDA Draft Guidance, Health IT, Medical Devices

FDA Releases Draft Guidance for Reporting Adverse Events Related to HCT/Ps

The U.S. Food and Drug Administration (FDA) released draft guidance titled Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271. The draft guidance is applicable to a wide range of non-reproductive HCT/Ps “containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” HCT/Ps excluded from the guidance include reproductive HCT/Ps; whole human organs; certain whole blood, blood components or blood derivative products subject to listing under 21 C.F.R. parts 207 and 607; secreted or extracted human products; minimally manipulated bone marrow HCT/Ps derived from animals; and in vitro diagnostic products.  When finalized, the draft guidance will supplement section XXII of the Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (December 2011) and replace Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (November 2005).  Comments to the draft guidance should be submitted by April 21, 2015 for FDA consideration.



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FDA Releases List of FY 2015 of Guidance Priorities

On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015.   This guidance is a first for the FDA and comes as a product of negotiations with the medical device industry over Medical Device User Fee Amendments of 2012 (MDUFA III).  The lists of guidance is broken into an A-List (which the FDA intends to publish) and a B-List (which the FDA will publish “as resources permit”).  There is a third list of historically released guidance – from 2005, 1995 and 1985 – that are “subject to focused retrospective review.”  Some of the key A-List items are:

  • Framework for Regulatory Oversight of Laboratory Developed Tests
  • FDA Notification and Medical Device Reporting for Laboratory Developed Tests
  • Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements
  • Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Need for Life Threatening of Irreversibly Debilitating Diseases or Conditions

 Important B-List items include:

  • Transfer of Ownership of a Premarket Notification: Questions & Answers
  • Direct Access Genetic In Vitro Diagnostics Testing (also known as Direct to Consumer Genetic Testing)
  • 3D Printing (Technical)

Comments may be submitted on any or all of the lists.  There was little reaction to the guidance from Capitol Hill.  However, the guidance was released the same week the newly-seated 114th Congress began its discussions to repeal the medical device tax and prepared to release draft proposals and legislation under the 21st Century Cures Initiative – which is related to the “discovery, development and delivery of treatment and cures.”

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Filed under Federal Transparency, Health IT, Health Reform

FDA Holds Teleconference re: Social Media Guidance

The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors and packers that use social media and the internet to promote FDA-approved products.  The FDA has made the PowerPoint and webinar Q&As publicly available for review.  Specifically, as we informed you here and here, the FDA issued the following three draft social media guidance documents:

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FDA Releases Two Social Media Guidance Documents

The U.S. Food and Drug Administration (FDA) released today two highly anticipated draft guidance documents:

  1. Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; and
  2. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.

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