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Medical Devices › Manufacturers › Final Guidance

Hogan Lovells

FDA delays UDI database enforcement for low-risk devices

Hogan Lovells on

On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a requirement that manufacturers of...more

Hogan Lovells

FDA spells out electromagnetic compatibility info needed in medical device premarket submissions

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” which details the...more

Alston & Bird

FDA to Develop National Standards for Drug Distributors – Medical Products Supply Chain Week in Review

Alston & Bird on

Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more

Manatt, Phelps & Phillips, LLP

FDA Issues Final Guidance on the Safer Technologies Program (STeP) for Medical Devices

Manatt, Phelps & Phillips, LLP on

On January 6 of this year, the Food and Drug Administration (FDA) released a final guidance on the Safer Technologies Program (STeP) for Medical Devices. The concept of STeP was first introduced by FDA in 2018 with the goal...more

Faegre Drinker Biddle & Reath LLP

FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...

Faegre Drinker Biddle & Reath LLP on

The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Guidance on Special 510(k) Pathway

Wilson Sonsini Goodrich & Rosati on

The Food and Drug Administration (FDA) recently finalized its guidance on the Special 510(k) Program—an optional pathway to commercial medical devices that have been modified since their previous 510(k) clearance. The Special...more

Faegre Drinker Biddle & Reath LLP

FDA’s Final Guidance on “Least Burdensome” Principles for Medical Devices

Faegre Drinker Biddle & Reath LLP on

The U.S. Food & Drug Administration’s (FDA’s) Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff, February 5, 2019, states that “medical device regulation should...more

Hogan Lovells

FDA releases final guidance document on PMA manufacturing site change supplements

Hogan Lovells on

On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA) application supplement reporting pathway for...more

King & Spalding

FDA and Life Sciences FDA Finalizes Guidances for “Consistent Communications” and Payor Communications

King & Spalding on

A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more

McDermott Will & Emery

FDA Finalizes Guidance on Payor Communications

McDermott Will & Emery on

On June 12, 2018, the US Food and Drug Administration (FDA) finalized its Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers guidance (Final Guidance)....more

Cooley LLP

Blog: FDA Finalizes Two Guidance Documents Regarding Medical Product Communications

Cooley LLP on

The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities —...more

Holland & Knight LLP

FDA Issues Long-Awaited Final Guidance on Interoperable Medical Devices

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more

Morgan Lewis

FDA Issues Final Guidance on Postmarket Cybersecurity

Morgan Lewis on

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

McDermott Will & Emery

FDA Extends Deadline for Removal of NDC and NHRIC Numbers from Device Labeling and Packaging

McDermott Will & Emery on

On August 30, 2016, the US Food and Drug Administration (FDA) published final guidance in which the agency announced it does not intend to enforce its prohibition against the inclusion of National Health Related Item Code...more

Parker Poe Adams & Bernstein LLP

New FDA Cybersecurity Guidance for Medical Device Manufacturers

Parker Poe Adams & Bernstein LLP on

Last month, the U.S. Food and Drug Administration issued its final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Those guidelines make non-binding recommendations on the...more

Morgan Lewis

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

Morgan Lewis on

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

King & Spalding

Medical Devices and Cybersecurity Risks - DHS investigates at-risk devices

King & Spalding on

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more

Mintz - Privacy & Cybersecurity Viewpoints

A Different Kind of “Virus”: FDA Follows NIST Framework in Cybersecurity Guidance for Medical Devices

Mintz - Privacy & Cybersecurity Viewpoints on

In past posts we’ve taken a close look at the Framework for Improving Critical Infrastructure Cybersecurity put forth by the National Institute of Standards and Technology (NIST), exploring its wide-ranging implications for...more

Morgan Lewis

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

Morgan Lewis on

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

King & Spalding

FDA Releases Draft Guidance on Medical Device Reporting - Will Supersede 1997 Guidance

King & Spalding on

On July 9, 2013, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Medical Device Reporting for Manufacturers (hereinafter “Draft Guidance”). FDA has not updated its formal...more

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