Product: drug manufacturing facilityRead More

FDA issued the draft guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” June 7, 2018. Note that there are a variety of types of Q-submissions and they do not need to be tied to a specific planned 510(k) or other premarket submission. Also note that they are not meant to...Read More

FDA Issued a Proposed Order to Down-Classify Certain Radiological Medical Image Analyzers, which include computer-assisted detection devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices, from class III to class II devices.  If finalized, this proposed order will reclassify computer-assisted detection devices for certain radiological applications from...Read More

Product: drug manufacturing facilityRead More

FDA issued a draft guidance dated April 27, 2018 titled: “Multiple Function Device Products: Policy and Considerations.”  This guidance expands on when and how FDA intends to assess the impact of other functions that are not the subject of a premarket review on the safety and effectiveness of a device function subject to FDA review.  It...Read More

FDA issued a draft guidance for comment: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Contains Nonbinding Recommendations Draft – Not for Implementation Equivalence through Performance Criteria. The outline shows a Section 17 for software information. The outline can be viewed here.Read More

The Global Unique Device Identification Database is a database administered by the FDA that will serve as a reference catalog for every device with an identifier. May 2018 will start implementation of the releasability logic and the review period. Public release of premarket submission and supplement numbers on AccessGUDID and OpenFDA will begin in June 2018.Read More

Prepared a visual aide (one of many we use in our training courses) of key Medical Devices Standards and FDA guidance related to software.  Enjoy! SoftwareCPR Sw Stds GuidancesRead More

This content is only available to Premium level and Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR has prepared a collection of production and process validation material suitable for training in Production and Quality Systems 820.70(i) Validation including Part 11.  Portions could be made into handouts or provided electronically.  Download the manual...Read More

You can search the app stores for SoftwareCPR® to download on an iPhone or Android. The app provides key FDA regulations and Software Guidances for quick reference and is organized by section. Impress your friends by accessing the exact text of FDA documents wherever you go. We plan to add additional documents over time.Read More

The FDA published the guidance document “Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions.” The guidance document is in Q&A format, and provides clarifications and recommendations to help stakeholders ensure that studies conducted in the U.S. or foreign countries comply with the new rule and revised regulations. FDA WebsiteRead More

FDA made public that the effective date for compliance with the final rule on “Human Subject Protection – Acceptance of Data from Clinical Investigations for Medical Devices.”  According to the announcement from FDA, the “update relates to the standards for accepting clinical data from clinical investigations conducted inside and outside the United States” with the stated...Read More

The FDA published the guidance document “Refuse to Accept Policy for 510(k)s.” This supersedes the original, issued on August 4, 2015. This revision provides for additional requirements to better ensure substantive content, not just administrative elements that are checked in the initial 15 day refuse to accept initial review. Refuse to Accept Policy for 510(k)sRead More

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...Read More

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...Read More

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...Read More

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...Read More

Product: drug manufacturing facilityRead More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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.Read More

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...Read More

The FDA maintains a dedicated webpage to provide ongoing information on FDA’s digital health initiative.Read More

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 appRead More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

I don’t even really like to use the word retrospectiveRead More

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 requiredRead More

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...Read More

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 inspectionRead More

"AAMI TIR69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems" available for purchaseRead More

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...Read More

Significant violations of CGMP regulations due to failure to maintain adequate written records of major equipment maintenance and data integrity issuesRead More

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...Read More

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 PacemakersRead More

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...Read More

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...Read More

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.Read More

The FDA published a FAQ for companies that may be interested in participating in the Digital Health Software Precertification Program.Read More