fda publishes final guidance for medical device

FDA publishes final guidance on ANDA/505(b)(2) NDA

5/10/2019On Thursday FDA published the final guidance document "Determining Whether to Submit an ANDA or a 505(b)(2) Application" that contains minor revisions to the October 2017 draft guidance The final guidance contains no significant substantive changes to the draft version but here are a few interesting tidbits:

US: FDA published finalized guidance on inspections of

The Food and Drug Administration (FDA) issued guidance on inspections of medical device establishments The finalized document follows draft guidance issued on March 28 2019 filling a requirement of the FDA Reauthorization Act of 2017 (FDARA) The guidance specifies how the Agency will implement uniform []

FDA Publishes FY2015 Medical Device Guidance Agenda

FDA agreed to publish and seek feedback on an annual list of prioritized draft and final guidance documents that the Agency intends to publish in the coming year United States: FDA Publishes FY2015 Medical Device Guidance Agenda 15 January 2015 by

FDA publishes final guidance on medical device

FDA publishes final guidance on medical device communications 29 June 2018 Association (AdvaMed) responded to the guidance with president and CEO Scott WhiTongWeir saying: "AdvaMed commends FDA's recently issued final guidance on communications between medical technology companies and payers

FDA Finalizes its Guidance Regarding Medical Device

As part of its end of year rush to issue guidance documents FDA issued a final guidance document Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types on December 30 2016 The title page of a guidance document rarely has anything to comment on but in this case it is at least worth noting that FDA changed the title from "Defining Accessories

GS1 US Publishes Guideline Update: Applying the GS1

5/30/2019These include U S FDA Draft Guidance Final Guidance and extensions or modifications to certain aspects of the rule such as direct marking of devices enforcement policy on National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers assigned to devices and form and content of the unique device identifier among others

FDA Publishes Final Guidance on Medical Device Reporting

The FDA's final guidance on medical device reporting for manufacturers updates its policy and clarifies the agency's interpretations of the regulatory requirements under 21 CFR part 803 – FDA release FDA has also scheduled a webinar to help companies understand the final

FDA Publishes Final Guidance On ANDA/505(B)(2) NDA

On Thursday FDA published the final guidance document Determining Whether to Submit an ANDA or a 505(b)(2) Application that contains minor revisions to the October 2017 draft guidance The final guidance contains no significant substantive changes to the draft version but here are a

FDA Publishes Draft Guidance on CDS Software and

Simultaneously FDA also issued a draft guidance document that describes how the agency intends to revise four previously issued digital health final guidance documents for consistency with the 21st Century Cures Act which amended the Federal Food Drug and Cosmetic Act's definition of "device" to exclude software with several types of functions (including certain CDS functionalities)


04 08 2019Informational Several revised or updates USFDA guidance: Medical Device and FDA Regulations and Standards News: 0: Sep 19 2019: J: Revised MDSAP Audit Model - Health Canada - October 30 2017: ISO 13485:2016 - Medical Device Quality Management Systems: 7: Nov 21 2017: SCMH Awareness Webinar Focused on the revised Advanced Product Quality

FDA Publishes Final Recommendations on Blood Glucose

The FDA recently finalized its recommendations ("guidance") on accuracy and other requirements for new blood glucose meters For people with diabetes the main outcomes of the new guidance are that new meters will need to be more accurate conduct larger studies before they are approved and more clearly display accuracy on their packaging

CDS software labels for staplers and breast implants

Dive Brief: Final guidance on a variety of topics including the Safer Technologies Program for medical devices labeling recommendations for surgical staplers clinical decision support software and device-specific Safety and Performance Based Pathway implementation are among FDA's priorities for the 2020 fiscal year the agency announced Friday A variety of device safety draft guidance

US FDA publishes final guidance on 3D printed medical

FDA characterizes the final guidance as both a "comprehensive technical framework" for 3D printed devices and a "leapfrog guidance " serving as a platform for the agency to air initial thoughts and approaches regarding new and burgeoning medical device technologies and subject to change according to new developments in the additive manufacturing arena

Beyond Mobile Medical App Guidance: What to Worry

Beyond Mobile Medical App Guidance What to Worry About After FDA Publishes Its "Final" GuidelinesClick Here for Additional Resources A conversation with Bradley Merrill Thompson Member of the Firm at Epstein Becker Green and General Counsel to the mHealth Regulatory Coalition (see Bio) We discuss prospects for FDA's final guidance on regulation of mobile medical apps (MMAs)

Medical Device Exemptions 510(k) and GMP Requirements

Limitations of device exemptions are covered under 21 CFR xxx 9 where xxx refers to Parts 862-892 If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892 a premarket notification application and FDA clearance is not required before marketing the device in the U S However these

FDA Guidance for Industry Update – Process Validation

drugs biological products medical devices cosmetics and products that emit radiation To facilitate this purpose the FDA issues guidance documents for auditors and industry to help define the practical expectations of meeting the US GMP regulations In January 2011 the FDA published an updated guidance entitled Guidance for Industry -

medical devices

On October 2 2014 the Food and Drug Administration (FDA) released a final guidance document titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" The FDA said that the "need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless Internet- and

FDA Releases Revised Draft Guidance On CDS Software

10/1/2019The second is a final guidance that brings several existing medical software policies from the agency into accordance with provisions outlined in 2016's 21st Century Cures Act In particular the document describes certain types of software products that will no longer fall within the agency's definition of a medical device

FDA publishes final guidance on Heparin

This guidance applies to medical devices and device-led combination products that include heparin sodium or low molecular weight heparin The guidance clarifies FDA's current labeling and safety testing recommendations for heparin lock flush solution products and heparin-bonded products as well as recommendations for safety testing for heparin-containing products

Medical Device Exemptions 510(k) and GMP Requirements

Medical Device Exemptions 510(k) and GMP Requirements FDA Home Medical Devices Databases - Introduction Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class All devices in this list are 510(k) exempt unless further qualified by a footnote Only devices annotated by (*) are also exempt from GMP except for general

FDA publishes final cGMP rule on drug device and

FDA publishes final cGMP rule on drug device and biological product combinations by Raleigh Malik | Jan 30 2013 The FDA published a final rule entitled Current Good Manufacturing Practice Requirements for Combination Products to provide clarification of cGMP requirements for products that are made up of a combination of devices drugs and/or biologics The new guideline applies to both

FDA Publishes List of Over 1 000 Devices Exempted from

3/23/2017On March 14 2017 the US FDA published a notice in the Federal Register (FR Doc Number 217-04938) indicating that the Agency has identified a list of Class II devices that when finalized will be exempted from premarket notification requirements (i e 510(k)) The list encompasses 1 003 class II devices many of which were previously identified []

Final Report: Fees for Drugs and Medical Devices

Applications for amendment of Class IV medical device licence — changes referred to in paragraph 34(a) of the Medical Devices Regulations that relate to manufacturing $1 903 $2 379 $2 974 $3 717 75 calendar days to complete Review 1 Annex A Table 7 Footnote * 9

Susan Kelly

FDA publishes guidance on device performance bench tests April 26 2019 FDA pitches stronger controls new labeling for surgical staplers April 24 2019 Edwards Lifesciences beats profit forecasts amid low-risk TAVR momentum April 24 2019 Study supports genetic testing for sudden cardiac arrest April 23 2019 Obesity device to slow stomach emptying gets approval April 23 2019 More

FDA draft guidance

The FDA has entered into the federal register a new draft guidance pertaining to software as a medical device (SaMD) The guidance is presented as representing the FDA's current thinking on establishing clinical evaluation guidelines for SaMD but is written by an international organization of device regulators the International Medical Device Regulators Forum of which FDA is a member

FDA Publishes DSCSA Grandfathering Guidance Exactly 2

11/27/2017Today is November 27 2017 the four year anniversary of President Obama signing the Drug Quality and Security Act (DQSA) into law (see "It's Official President Obama Signs H R 3204 DQSA Into Law") and it is the two year anniversary of the due date for the FDA to publish four guidance documents—one of the four on grandfathering (see "FDA DSCSA Deadline Passes Quietly")

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