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FDA New Guidance on Q-Submission Meetings for Devicemakers- Q-submission process

  • Industry: Medical Devices

On June 7 2018 FDA has released new draft guidance related to meetings devicemakers may request under the agency’s Pre-Submission Program — it is also known as Q-submission meetings as the agency assigns applications a Q number.

 
 
The term “Q-Submission” or “Q-Sub” refers to the system used to track the collection of interactions These are important opportunities for submitters to share information with FDA and receive input outside of the submission of an IDE, IND, marketing submission, or CW. The interactions tracked in the Q-Sub program may be used at different points along the total product life cycle for a device and are voluntary.
 
The draft guidance covers various categories of device-related submissions, - IDE, PMA, HDE, De Novo request, 510(k), Dual,
 BLA, IND , humanitarian device exemptions. it also applies to pre-submission feedback and certain INDs

FDA Releases New Final Guidance on Medical Device Reporting Requirements for Manufacturers

  • Industry: Medical Devices

FDA Releases New Final Guidance on Medical Device Reporting Requirements for Manufacturers

The US FDA has recently finalized its 2013 draft guidance on the Medical Device Reporting (MDR) requirements for manufacturers. The guidance supersedes the 1997 MDR guidance document. The finalized guidance document addresses the reporting and recordkeeping requirements for device related adverse events and malfunctions.

The guidance requires the submission of three types of MDR reports. These include 30-day (initial) reports [21 CFR 803.10(c). 803.20 and 803.50], 5 - day reports [21 CFR 803.10(c), 803.20 and 803.53] and supplemental reports [21 CFR 803.10(c) and 803.56]. It further details the required information to be included in the each kind of report and the necessary time frame for submissions.

FDA Guidance on Postmarket Management of Cybersecurity in Medical Devices

  • Industry: Medical Devices

FDA Guidance on Postmarket Management of Cybersecurity in Medical Devices

The significant technological advancements in medical device in today’s world has laterally increased the risk of cybersecurity breaches that could affect device’s performance and functionality. Hence, medical device manufacturers are required to consider cybersecurity throughout the product lifecycle, including during the research and development, design, production, distribution, and maintenance of the device.

FDA Guidance on cGMP Requirements for Combination Products

  • Industry: Drugs and Chemicals (Pharma)

FDA Guidance on cGMP Requirements for Combination Products

The US regulatory pathway for combination products is not always very clear. As combination products include constituents that would normally be regulated under different types of governing authorities, they raise regulatory, policy, and review management challenges.

US FDA has recently issued a final guidance detailing the cGMP requirements for combination products including drug-drug, drug-device, device-biologic or drug-biologic combination products. The guidance follows the 2013 final rule on cGMP requirements for combination products.

General Principles of Software Validation

  • Industry: Medical Devices

General Principles of Software Validation

Software validation is a vital tool used to assure the quality of software and software automated operations for medical devices. Software validation can increase the reliability and accuracy of the device, subsequently leading to fewer recalls and corrective actions, less risk to patients, decreased failure rates, and reduced liability to device manufacturers.

The FDA guidance details the general validation principles that are appropriate to the validation of device software or the validation of software used to design, develop, or manufacture medical devices.

Implementing Design Controls for Device Manufacturers

  • Industry: Medical Devices

Implementing Design Controls for Device Manufacturers

Design controls are a part of an inclusive quality system that covers the life of a device from the development of device requirements through design, production, distribution, use, maintenance, and ultimately, obsolescence. Design control also applies to the changes to the process design including those occurring after a device has been offered to the market.

This guidance document applies to the design of the medical devices including new designs as well as changes to the existing device designs.

Draft Guidance: Software as a Medical Device (SAMD): Clinical Evaluation

  • Industry: Medical Devices

Draft Guidance: Software as a Medical Device (SAMD): Clinical Evaluation

The US FDA has released the draft guidance on the clinical evaluation of software as a medical device (SaMD) prepared by the International Medical Device Regulators Forum (IMDRF). The Draft Guidance describes standards for determining the clinical validity by demonstrating the analytical validity, the scientific validity and clinical performance of the SaMD.

The guidance states, "Based on the significant impact SaMD has on clinical outcomes and patient care, a SaMD manufacturer is expected to gather, analyze, and evaluate data, and develop evidence to demonstrate the assurance of safety, effectiveness and performance of the SaMD."

FDA Draft Guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifica ....

  • Industry: Medical Devices

On December 27, 2011, the FDA released new draft guidance on 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications. The guidance aims to explain the decision-making process of FDA for determining substantial equivalence and provides additional details about the regulations, strategies, and norms upon which the FDA’s review of the 510(k) application is based. The guidance also provides information about new policies regarding Special 510(k) and Abbreviated 510(k) submissions to FDA.

FDA Draft Guidance on Evaluation of Sex Differences in Medical Device Clinical Studies

  • Industry: Medical Devices

The FDA has issued a draft guidance that aims at increasing the representation of women in medical device clinical trials. Aimed at medical device manufacturers and developers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

Proposed CMS Rule: Medicare, Medicaid, Children's Health Insurance Programs; Transparency Repor ....

  • Industry: Drugs and Chemicals (Pharma)

The Physician Payment Sunshine Act was passed in 2010 as part of President Barack Obama’s legislative agenda to overhaul healthcare. The Centers for Medicine and Medicaid Services (CMS) was tasked with the drafting of the rules to enforce the Act’s requirements. CMS published its proposed rule in December, 2011.

FDA Guidance - Medical Device Reporting for Manufacturers

  • Industry: Medical Devices

This guidance document describes the new Medical Device Reporting requirements for manufacturers. It is intended for both domestic and foreign medical device manufacturers, and is based on the Medical Device Reporting (MDR) requirement published in the final rule dated December 11, 1995. The MDR regulation provides a mechanism for FDA to identify and monitor significant adverse events involving medical devices, so that problems may be detected and corrected in a timely manner.

FDA Draft Guidance on Risk Information in Prescription Drug & Medical Device Ads, Promotional L ....

  • Industry: Drugs and Chemicals (Pharma)

The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.

FDA Draft Guidance on Human Factors and Usability Engineering to Optimize Medical Device Design

  • Industry: Medical Devices

In June 2011, the Food and Drug Administration issued draft guidance on using human factors and usability engineering to optimize medical device design. The aim of this guidance document is to help the medical device industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle.

FDA Draft Guidance for Device Industry and Staff for Postmarket Surveillance

  • Industry: Medical Devices

On August 16, 2011, the FDA issued draft guidance for the medical device industry and its own staff on how to conduct postmarket surveillance. This new guidance, when it is finalized, is expected to supersede the guidelines issued in 2006.

Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when M ....

  • Industry: Medical Devices

FDA has developed this draft guidance document to provide greater clarity for FDA reviewers and industry regarding the factors FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices. FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process.

FY 2011 Medical Device User Fee Small Business Qualification and Certification

  • Industry: Medical Devices

This guidance explains how your business may qualify as a “small business” and pay most FY 2011 medical device user fees at substantially discounted rates; if you qualify as a small business, you may also qualify to obtain a one-time waiver of the fee for your first (ever) premarket application (premarket approval application, biologics license application, product development protocol, or premarket report).

General Principles of Software Validation; Final Guidance for Industry and FDA Staff

  • Industry: Medical Devices

This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.

This guidance applies to:

  • Software used as a component, part, or accessory of a medical device;
  • Software that is itself a medical device (e.g., blood establishment software);
  • Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
  • Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).

21 CFR Part 820 - Quality System Regulation-- Quality System Requirements, Design, Document, Pu ....

  • Industry: Medical Devices

Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).
 

This regulation is divided in to 15 subparts ranging from A to O. This page contains  the underlying requirements of  Subpart B, C, D, E and K of the regulation which deals with Quality System Requirements, Design, Document, Purchasing Control, Production and Process Controls, Labeling and Packaging Control.

Guidance for Industry1 Patient-Reported Outcome Measures:Use in Medical Product Development to ....

  • Industry: Medical Devices

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance

 

 

Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development ....

  • Industry: Medical Devices

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.'' This guidance describes how FDA reviews and evaluates patient-reported outcome (PRO) instruments used to measure treatment benefit in medical product clinical trials. It also provides recommendations on how sponsors can use study results measured by PRO
instruments to support claims in approved medical product labeling.

This guidance finalizes the draft guidance published on February 3, 2006.
 

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