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Agency Alerts
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January 28, 2016
FDA Extends Comment Period for Emerging Medical Device Signals Draft Guidance
On December 31, 2015, FDA released a draft guidance entitled “Public Notification of Emerging Postmarket Medical Device Signals (‘Emerging Signals’),” which stated its plans to take a more aggressive...
Medical Devices
Agency Alerts
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February 28, 2019
Draft Guidance: Requesting Nonbinding Feedback After an FDA Inspection of Your Medical Device Establishment
On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted...
Medical Devices
Agency Alerts
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November 30, 2018
FDA Announces Plans to Modernize its 510(k) Medical Device Approval Process
On Monday, November 26th, FDA announced changes to modernize the 510(k) clearance pathway, which is the most common medical device submission and allows for the allows for the “clearance of low- to...