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FDA finalizes advice on cybersecurity info to include in device submissions

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which advises medical device manufacturers on...more

FDA issues milestone draft guidance on decentralized clinical trial design & implementation

The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices.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

FDA expands inspection obstruction guidance to apply to device facilities

The U.S. Food and Drug Administration (FDA) has published the revised draft guidance “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection,” which, if finalized, would expand...more

FDA plans to expand remote evaluations, record reviews post-pandemic

The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how it will continue to conduct remote regulatory assessments (RRAs) after the COVID-19 public health emergency (PHE) ends. This guidance...more

FDA updates “cybersecurity in medical devices” guidance, seeks industry input - Draft guidance addresses quality system...

The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...more

FDA explains when medical device makers must notify of an interruption in manufacturing

On Monday, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” which aims to...more

“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more

FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for...more

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will supersede the currently in effect Special...more

Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank." ...more

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