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Life Sciences › Draft Guidance › Manufacturers

Wilson Sonsini Goodrich & Rosati

FDA Issues Draft Guidance on Predetermined Change Control Plans for Medical Devices

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The U.S. Food and Drug Administration (FDA) recently released a draft guidance describing its proposed approach to reviewing and authorizing a predetermined change control plan (PCCP) in a marketing submission for a device...more

Mintz - Health Care Viewpoints

FDA Rolls Out Innovative New Designation Programs in Response to Congressional Mandates

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Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...more

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

Goodwin on

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

Jones Day

FDA on Board With Continuing Remote Inspections

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The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Troutman Pepper

FDA Issues New Draft Guidance for Unapproved Use Communications

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On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Hogan Lovells

FDA issues milestone draft guidance on decentralized clinical trial design & implementation

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The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more

MoFo Life Sciences

FDA Clarifies The Human Factors Or Usability Information To Include In A Device Marketing Submission

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If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing device?...more

Akin Gump Strauss Hauer & Feld LLP

FDA Changes Direction in Final CDS Guidance

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FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

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The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Hogan Lovells

FDA outlines rescission of Breakthrough Therapy Designation - Guidance potentially signals closer agency scrutiny of designations...

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Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will analyze whether to rescind a breakthrough therapy...more

Arnall Golden Gregory LLP

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

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Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more

Stinson LLP

Medical Device Third-Party Servicers: Will FDA Treat You as a Manufacturer?

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Recently, in response to requests by stakeholders, FDA extended the deadline for comments to its draft guidance "Remanufacturing of Medical Devices," which provides the agency's current thinking regarding the distinction...more

Mintz - Health Care Viewpoints

Are You a Medical Device Servicer or Remanufacturer? FDA’s New Guidance May Help…Or Not

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On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities...more

Harris Beach PLLC

FDA Proposes Strengthening Warning Labels on Breast Implants

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The Food and Drug Administration has issued a new draft breast implant guidance recommending that manufacturers strengthen labeling about the potential complications and risks of the medical devices, particularly by adding...more

Stinson LLP

FDA Draft Guidance and Pilot Program Seek to Expand Device Modifications Appropriate for the Special 510(k) Program

Stinson LLP on

In its continued effort to reduce time to market for regulated products and improve transparency, the Food and Drug Administration (FDA) published a draft guidance last Friday that, among other things, proposes to (i) expand...more

Morgan Lewis

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

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3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

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