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Category Archives: FDA

Share on Google+ September 24, 2018

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FDA Proposing to Amend Medical Device Premarket Regulations to Remove Paper and Multiple Copies and Replace them with Requirements for a Single Submission in Electronic Format

Category : FDA

FDA Proposing to Amend Medical Device Premarket Regulations to Remove Paper and Multiple Copies and Replace them with Requirements for a Single Submission in Electronic Format (proposed Rule) Executive Summary The US FDA has proposed to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic

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Share on Google+ August 6, 2018

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US FDA FY 2019 MDUFA User Fees

Category : FDA, Regulatory

On 08/01/2018, the US Food and Drug Administration (FDA) published the user fee amounts it will collect in FY2019 from the manufacturers of medical devices. Current Law User Fees: +$2.791 Million (Center: +$2.755 million / Field: +$0.036 million) The Devices Program request includes an increase of $2.8 million for user fees authorized under Food and Drug Administration Reauthorization Act of

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Share on Google+ January 19, 2018

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APS Regulatory Update: FDA Delays UDI Enforcement for Class I and Unclassified Devices

Category : FDA, Regulatory

US FDA has pushed back enforcement of unique device identification (UDI) compliance deadlines for some low-risk (Class I and Unclassified) medical devices by at least two years.  Table 1 below provides the compliance dates. Table 1: Compliance Dates for Class I and Unclassified Devices   Type of Device FDA does not intend to enforce UDI labeling (21 CFR 801.20 &

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Share on Google+ October 30, 2017

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FDA Finalizes 510(k) Guidances on When to Submit a New 510(k)

Category : FDA, Medical Device testing, Regulatory

On October 25, 2017, the FDA released two final guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” which focuses on software-specific changes and complements the broader guidance document.  These guidance documents

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Share on Google+ September 18, 2017

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FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework

Category : FDA

On 07 September, 2017, FDA announced its plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework. FDA’s goal is to ensure that its policies and regulations keep pace with the challenges encountered in protecting consumers, and the opportunities to improve lives. This new effort includes areas where FDA’s rules concerning new drugs

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Share on Google+ September 11, 2017

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Strengthening EU-US cooperation in medicine inspections

Category : FDA

New commitment allows FDA to share full inspection reports with European Commission and EMA The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with

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