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fda
The U.S. Food and Drug Administration released the immediately-in-effect (IIE) guidance document, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices.” The guidance lists and explains several key elements of FDA’s enforcement discretion policy, including the Agency’s intention to not enforce standard date formatting, labeling, and GUDID data submission requirements for...
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The U.S. Food and Drug Administration issued a Federal Register notice with a proposed program for Voluntary Malfunction Summary Reporting. When finalized, this program would allow manufacturers to report certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis instead of individually within 30 days. The proposed Voluntary Malfunction Summary Reporting...
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The U.S. Food and Drug Administration issued a Federal Register notice with a proposed program for Voluntary Malfunction Summary Reporting. When finalized, this program would allow manufacturers to report certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis instead of individually within 30 days. The proposed Voluntary Malfunction Summary Reporting...
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Today the FDA is announcing the availability of the updated final guidance, “Medical Device Accessories – Describing Accessories and Classification Pathways”. This guidance was updated and replaces the Jan 2017 version to include new mechanisms to request (1) a different classification for an existing accessory type (i.e., accessories already on the market), and (2) for...
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FDA issued its list of planned Medical Device Guidance development for 2018. This list has 2 parts: priority development referred to as the A-List and other development referred to as B-list.. Note that FDA does not commit to accomplishing all items on either list; it is just stating its current intention. The A-List includes a...
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On Dec. 14, 2017, the FDA released a Draft guidance dated Dec. 15, 2017 “The Least Burdensome Provisions: Concept and Principles.” This guidance discusses FDA’s intent and approach to applying Least Burdensome Principles to the total product lifecycle for medical devices based on requirements in FDAMA (Public Law 105-115), the FDA Safety and Innovation Act...
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On Dec. 8, 2017, the FDA released the draft guidance, “Clinical and Patient Decision Support Software.” This guidance addresses software for decision support in two categories: one used by Healthcare Professionals, the other used personally by patients and non-health professionals. It provides FDA interpretation of which types of Decision Support Software do not meet the...
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On Dec. 8, 2017, the FDA released the final guidance, “Software as a Medical Device (SAMD): Clinical Evaluation.” The October 14, 2016, draft is now obsolete. This guidance is actually the use of an International Medical Device Regulators Forum (IMDRF) document completed in June of 2017, so this represents broad international consensus. This guidance discusses...
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On Dec. 8, 2017, the FDA released draft guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.” This guidance discusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or...
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On Dec. 8, 2017 FDA released a Draft guidance “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”. This guidance dsicusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or...
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On Dec. 8, 2017 FDA released a Draft guidance “Clinical and Patient Decision Support Software”. This guidance addresses software for decision support in two categories: one used by Healthcare Professionals, the other used personally by patients and non-health professionals. It provides FDA interpretation of which types of Decision Support Software do not meet the definition...
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On December 7, 2017, FDA Commissioner Scott Gottlieb, M.D., released the statement, “Advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation.” This statement announces the release of several new draft and final guidances as part of the FDA’s Health Innovation Action Plan published previously. The new guidances are posted separately...
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Earlier this year FDA released the DH Action Plan, initiating several new guidances, policy changes, and its pre-certification program. Note: Information on the pre-certification program progress during 2017 and release of new guidance (December 2017) is posted separately.
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An excerpt of the Medical Device Innovations Section of the US Law PLAW-114Publ255 referred to as the “21st Century Cures Act” and published in December of 2016 is at the link provided. There are many important elements of this law, including how accessories are classified and what software functions are not outside the definition of...
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The FDA maintains a dedicated webpage to provide ongoing information on FDA’s digital health initiative.
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Want a free Android app as a quick reference to the regulations? Paul Felten of SoftwareCPR has developed a new app just for that purpose. You can find it by searching for “SoftwareCPR” in the Google Play store!  Google Play – SoftwareCPR app
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The FDA issued its first approval of a Digital Medicine, ABILIFY MYCITE®, a new innovative treatment option in mental health. Otsuka, with the help of Proteus Inc., developed a sensor as part of the pill that communicates externally to provide confirmation the pill was ingested, along with details about it. This is for serious mental...
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FDA regulation of Medical Device Data Systems has changed significantly over the years. This, together with the blurred line between MDDS and general health information technology, interfaces between MDDS and regulated medical devices, the actual criteria for deciding if something is classified as a Medical Device Data System, and different regulatory requirements outside the US...
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The FDA release a final guidance, “De Novo Classification Process (Evaluation of Automatic Class III Designation),” on October 30, 2017. This supersedes “New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff” dated February 19, 1998. This guidance defines the process for De Novo submissions for devices with no...
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The FDA published a draft guidance, “Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff,” on October 25, 2017. The full guidance is at the link provided. This supersedes the Expedited Access Pathway (EAP) introduced in 2015 and the Priority Review Program. The Breakthrough Devices Program is a voluntary program for...
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The FDA issued a final guidance entitled “Deciding When to Submit a 510(k) for a Software Change to an Existing Device)” dated October 25, 2017. This guidance clarifies for the industry how to determine which software changes to a 510(k)-cleared device require a new 510(k). It seems to reflect what the FDA has applied in...
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The FDA issued a new Final guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” on October 25, 2017. The full guidance is at the link provided. This supersedes the 1997 guidance. Note that FDA simultaneously released a Final guidance for when to submit a new 510(k) for software changes...
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FDA published a draft guidance “Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff” dated 10/25/17. The full guidance is at the link provided. This supersedes the Expedited Access Pathway (EAP) introduced in 2015 and the Priority Review Program. The Breakthrough Devices Program is a voluntary program for certain medical devices...
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Supersedes 1997 guidance. FDA issued a new Final guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device” dated Oct. 25, 2017. TThe full guidance is at the link provided. Note that FDA simultaneously released a Final guidance for when to submit a new 510(k) for software changes specifically. Deciding When...
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I don’t even really like to use the word retrospective
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The firm's quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured - remediation required
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The U.S. Food and Drug Administration released guidance document, “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff,” dated September 29, 2017. The guidance lists and explains the process for requesting meetings with the FDA. It explains proper use of these meetings, including examples of appropriate...
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The PMA CtQ pilot program aims to evaluate device design and manufacturing process quality information early on, giving the applicants the option of foregoing the standard PMA pre-approval inspection
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"AAMI TIR69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems" available for purchase
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Participation in the PMA CtQ pilot program is voluntary and the program aims to evaluate device design and manufacturing process quality information early on to assist FDA in its review of the PMA manufacturing section and post-approval inspections. This voluntary pilot program is part of the FDA’s ongoing Case for Quality effort to apply innovative...
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Significant violations of CGMP regulations due to failure to maintain adequate written records of major equipment maintenance and data integrity issues
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The FDA issued the final guidance entitled “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” This guidance addresses medical devices that exchange information; whether wired or wireless, or through the internet. It includes unidirectional exchange, bidirectional, or command and control. The guidance focuses on data exchange not physical connection types. It includes a...
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On August 29, 2017, the FDA issued “Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s (formerly St. Jude Medical’s) Implantable Cardiac Pacemakers: FDA Safety Communication.” The full document is at the link provided. Firmware Update to Address Cybersecurity Vulnerabilities in Abbott Pacemakers
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Testing activities should neither end with the release of the product nor once test documentation is complete, but should continue with the reduction of any test debt. Test debt is essentially a form of technical debt. Like technical debt, test debt is incurred during a project when compromises are made in the creation of test...
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The FDA published a list of standards added to their recognition list on August 21, 2017. IEC 82304-1 Edition 1.0 2016-10. Health software part 1: General requirements for product safety are included on this list in the Software/Informatics Section, along with a number of other standards related to device communication (including specifics of glucose meters...
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UL 2900-1 Ed.1 2017 Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements was recognized by FDA on August 21, 2017. See at: FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047.
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The FDA published a FAQ for companies that may be interested in participating in the Digital Health Software Precertification Program.
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The FDA held a meeting and webcast regarding initial development of its new approach for Digital Health Regulation. The FDA’s Digital Health Precertification webpage is at the link provided, and the slides from their presentation can be downloaded.
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"Based upon the company’s precertification level and the level of risk for the device, the product (or modifications to a product) may be able to go directly to market or undergo a streamlined submission review"
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FDA issued a new draft guidance entitled”Draft Guidance for Industry; How To Prepare a Pre-Request for Designation”. This guidance is intended to describe informal interaction with FDA that might lead to a formal Designation request to determine wether a product will be regulator as a device or a drug and some combination thereof. The full...
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FDA issues a new draft guidance in June 2017 titled “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers”.  This guidance while scoped for clinical investigations has information that is probably useful and defensible for assessing or ensuring compliance with other types of systems subject...
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FDA CDRHLearn released a new tutorial entitled ‘Electronic Submission of 806 Reports of Corrections and Removals”. The full tutorial is at the link provided. FDA Tutorial E-submission of 806 reports
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http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm563249.htm
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http://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/
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We help you meet the intent of the rule -- not the hype
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The FDA page on Medical Device Use of Symbols in Labeling is at the link provided. FDA currently allows use of symbols in place of text for medical devices and certain biologics provided the use is compliant with 21 CFR Parts 660, 801, and 809. FDA Use of Symbols in Medical Device Labeling
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At the AAMI/FDA Software Regulatory Class being held this week, it was stated that the following are expected to be released this summer by FDA: – Revision to the premarket cybersecurity guidance – Final of the interoperability guidance
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FDA seeks manufacturers to provide onsite learning opportunities for FDA staff. In the areas of Digital Health/Software FDA is interested in 4 topics: Cybersecurity, Software Development, Total product life-cycle development processes and methodologies, and Software testing. The link provided is the main FDA webpage on this program and has a link to the full list...
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FDA issued a draft list of Class II Medical Devices exemptions from the 510(k) premarket notification requirements to comply with the 21st Century Cures Act. Note that 884.1630 is NOT exempt if it contains software for image analysis or smartphone use. Other software-related sections of note are 86.2570 and 882.1470.
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