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Category Archives: Medical Device

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Long-Awaited Accessibility Standards for Medical Diagnostic Equipment Are Released

Our colleagues Joshua A. Stein and Frank C. Morris, Jr., at Epstein Becker Green have a post on the Health Employment And Labor blog that will be of interest to many of our readers: “The U.S. Access-Board Releases Long-Awaited Final Accessible Medical Diagnostic Equipment Standards.”

Following is an excerpt:

As part of a flurry of activity in the final days of the Obama Administration, the U.S. the Architectural and Transportation Barriers Compliance Board (the “Access Board”) has finally announced the release of its Accessibility Standards for Medical Diagnostic Equipment (the “MDE Standards”).  Published in the Federal Register … Continue Reading

FDA Says Yes to Pre-Approval Communications with Payors but Reaffirms its Approach to Restrictions on Off-Label Communications

Early January has seen the release by FDA of a flurry of information on drug and device manufacturer communications, largely reaffirming FDA’s long-held approach to restricting manufacturer communications regarding off-label uses of approved drugs and medical devices. The most significant positive development arising from these documents is the Agency’s concession on proactive pre-approval communications with payors about investigational drugs and devices, allowing certain information to be provided to payors prior to a product’s approval. FDA’s guidance documents issued this week also clarify some grey areas surrounding the circumstances under which manufacturers may communicate about information that is consistent with or … Continue Reading

FDA Announces November Public Hearing on Off-Label Communications: An Important Step Forward or a Signal that FDA is Headed Back to the Drawing Board?

On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.

In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders, including manufacturers, health care providers, patient advocates, payors, academics and public interest groups. The topics on which FDA is … Continue Reading

FDA Issues Draft Guidance Encouraging More Widespread Use of Electronic Health Record Data in Clinical Trials

On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations (“Draft Guidance”).  This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA’s expectations for the use of Electronic Health Record (“EHR”) data to clinical investigators, research institutions and sponsors of clinical research on drugs, biologics, medical devices and combination products conducted under an Investigational New Drug Application or Investigational Device Exemption.

While the recommendations set forth in the Draft Guidance do not … Continue Reading

50-State Survey on Telemental Health Laws in the United States

Telemental/telebehavioral Health SurveyEpstein Becker Green has just released the 50-State Survey of Telemental/Telebehavioral Health (2016), a groundbreaking, comprehensive survey on the laws, regulations, and regulatory policies impacting telemental health in all 50 states and the District of Columbia.

While other telehealth studies exist, this survey focuses solely on the remote delivery of behavioral health care.

Compiled by attorneys in Epstein Becker Green’s Telehealth practice, the survey details the rapid growth of telemental health—mental health care delivered via interactive audio or video, computer programs, or mobile applications—and the increasingly complex legal issues associated with this trend. Additionally, the survey provides one source … Continue Reading

3-D Printing Guidance Only a B-List Priority for FDA

While FDA made a push last fall to explore the technical challenges associated with 3-D printed devices (holding a public workshop in October 2014), the Agency’s planned guidance on the topic fell to the “B-list” in FDA’s 2015 medical device guidance agenda. According to the agenda, the Agency will issue a draft guidance document on 3-D printing as “guidance-development resources permit.” In light of the regulatory uncertainty facing 3-D printing stakeholders, this may seem like unwelcome news – but is it?

Recent comments from Agency officials suggest that immediate guidance is unnecessary because 3-D printing, despite prior comments, is … Continue Reading

Will Promoted Video Pave the Way for Drug and Medical Device Promotion on Twitter?

When FDA published its draft guidance Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices in June 2014, I, like many others with an interest in pharmaceutical and medical device promotion, believed that the issue of social media promotion of drugs and medical devices was largely settled. Even with the limited concessions offered by FDA to reduce the traditional risk disclosure requirements, absent a substantial shift in FDA’s position, Twitter was not going to be a medium that drug and device companies could use to effectively promote their products. Sure, companies … Continue Reading

What’s the Latest in 3-D Printing?

As we move into 2015, stories about the use of 3-D printing (also called additive manufacturing) in the health care industry continue to hit headlines. Some 3-D printed products are already available to U.S. patients, including knee and cranial implants, while others, including a graft device to treat aneurysms, are coming down the pipeline.

In touch with this trend, FDA has formed an Additive Manufacturing Working Group, and in October 2014, the Agency engaged industry stakeholders to discuss technical considerations surrounding 3-D printed products. However, according to workshop remarks from Dr. Matthew Di Prima, head of the FDA Additive Manufacturing … Continue Reading

3-D Printed Devices Pose Layers of Regulatory Questions

In early October, FDA held a public workshop to discuss the challenges of regulating medical devices made through additive manufacturing (also known as 3-D printing). Additive manufacturing gives designers the ability to build devices directly from 3-D images, like patient CT or MRI scans. As the push toward personalized medicine continues, 3-D printed devices hold incredible potential for advancing the ball. While additive manufacturing isn’t completely mainstream yet, FDA and industry stakeholders expect to see major growth in this field in coming years. Experts project that the global market for healthcare 3-D printing will reach $1.13 billion by 2020.

With … Continue Reading

Industry Interest by the Numbers: Comment Volume Suggests FDA Needs More Feedback from Companies on Social Media Guidance

As reported previously in this blog and in an EBG Client Alert, FDA has recently reopened the comment periods for three draft guidance documents released this year: two on social media promotion (open until October 29) and one on informed consent information sheets (open until October 27).  FDA does not often reopen the door to comment after the required notice-and-comment period has closed, and the fact that FDA has chosen to do so for these draft guidances is significant.  In all three cases, FDA received communications from stakeholders requesting additional time to digest the guidance and formulate helpful (hopefully) … Continue Reading

Social Media Promotion in Pharma and MedTech: Reopened Comment Period Means Manufacturers Have Another Chance to Ask FDA for Additional Clarification

Earlier this year, FDA released draft guidance the pharmaceutical and medical device industries had been awaiting for five years.  But instead of revolutionizing the Agency’s thinking on drug and device promotion, FDA’s social media guidance essentially continued the familiar credo on advertisements—accurate and not misleading, fair balance, substantiation—and ignored some of the central features of social media.  Last week, FDA reopened the comment period for the character-space limited communications and correcting third-party misinformation guidances.  Now companies have until October 29, 2014, to submit comments to FDA.

Our recently released article, “The Revolution Can Wait—Recent Social Media Continue Reading

Sterility Issues Are on the Forefront of the Federal Government’s Radar

Earlier this month, Customed, Inc. initiated the largest medical device recall ever recorded in FDA history.  The recall was of sterile convenience surgical packs and was due to packaging flaws.  These flaws could result in loss of sterility and lead to infection.  There have also been a number of voluntary recalls on the drug side related to sterility.  FDA has also issued warning letters to pharmaceutical companies for poor aseptic practices, among other Good Manufacturing Practices (cGMP) related issues.  These headlines should remind the medical device and pharmaceutical industry of the importance of sterility and the renewed focus the … Continue Reading

FDA Jurisdictional Determinations Should Not Be a Riddle, Wrapped in a Mystery, Inside an Enigma

Upon learning that FDA had lost another round in its battle to classify Diphoterine® Skin Wash (DSW) as a combination product with a drug primary mode of action and that Prevor, DSW’s manufacturer, was still fighting this issue nearly six years after it submitted its initial premarket notification for DSW, I turned into a five-year-old and kept asking why?

  • Why does FDA insists that a skin wash intended to “help prevent and minimize accidental chemical burn injuries” must be regulated as a drug but a drug-coated stent intended to improves arterial diameter is regulated as a device?
  • Why is
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