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  • FDA Publishes Final Refuse To Accept Guidance

    Today, FDA released the final version of its guidance document, relating to its Refuse to Accept (RTA) policy. The document, “Refuse to Accept Policy for 510(k)s,” dated January 30, 2018, is intended to outline the procedures and criteria that FDA will be using to assess whether the 510(k) submissions it receives meet the minimum requirements for substantive review. The agency released this information in hopes of streamlining the 510(k) process and ensuring that the substantive review process is more efficient. It is also intended to help submitters better understand FDA’s administrative review. Previous versions of the RTA guidance documents, according to the agency, simply spelled out broad issues and principles relating to the RTA policy, but did not address “specific content that is essential for 510(k) review.” As a result, reviewers found themselves wasting time on inadequate submissions, which consumed the agency’s resources. Review Process The 510(k) acceptance review is meant to assess whether a submission has all of the administrative elements necessary for substantive review. The agency included checklists for Traditional, Abbreviated, and Special 510(k)s in the guidance document to help reviewers conduct their acceptance reviews. When a submission is received, FDA will have no more than 15 days to review the submission for administrative completeness. If the submission is lacking one or more elements, the reviewer may request the information interactively (via e-mail) or put the submission on hold for up to 180 days to allow the submitter to provide the needed information. When the submitter forwards the requested documentation, the agency will have another 15 days to determine administrative adequacy. If the provided documentation is not complete, FDA will notify the contact person on file and provide a new checklist indicating the missing items. If FDA does not provide feedback regarding administrative adequacy within 15 days, the submitter will be notified on day 16 that the submission has entered substantive review. FDA’s Review Clock FDA’s review clock begins at the time a submission is deemed to be complete for substantive review. If a submission passes the first 15-day completeness evaluation, day one of FDA’s review clock is the date the Document Control Center received the submission. If the 510(k) is refused during the 15-day completeness assessment, the agency’s review clock will not begin until the Document Control Center receives the submission or additional information that results in an acceptance designation for the 510(k). The 15 days the agency uses to conduct its administrative completeness review are included in the 60 calendar days that the agency is allowed to conduct its substantive review (according to MDUFA III). The agency notes that FDA should consider only the presence or omission of the element or a rationale for the omission of the element or use of an alternative approach during the acceptance review. For example, if information, such as a test report, is provided, but is inadequate, the reviewer should mark the item as present and contact the submitter for additional information over the course of the substantive review. The test report would not be reviewed for adequacy during the 15-day administrative completeness review. The complete guidance document pertaining to FDA’s Refuse to Accept Policy has been published by FDA and can be found at this link: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM315014.pdf . IUVO Consulting helps companies submit 510(k)s to FDA. For more information about our 510(k) submission service, please contact us by e-mail ( compliance@iuvoconsulting.com ) or by phone (+1-757-514-1589).

  • Final Guidance Documents: When to submit new 510(k)s for devices and software

    FDA has issued final guidance documents to help medical device companies determine when to submit new 510(k)s for hardware and software. The agency will hold a webinar to explain the changes to industry on November 16, 2017. On October 25, 2017, the U.S. Food and Drug Administration published final guidance documents pertaining to when manufacturers should submit a new 510(k) when changes have been made to a medical device or to medical device software. These guidance documents closely follow what FDA issued back in 2016, and are intended to make "when to submit" decisions more consistent, easier, and more predictable. "Deciding When to Submit a 510(k) for a Change to an Existing Device" "Deciding When To Submit a 510(k) for a Software Change to an Existing Device" A New 510(k) Is Required When... Based on the final guidance documents, a new 510(k) may be required for a previously cleared class 2 medical device when there have been changes to labeling, technology, engineering, performance, or materials. This includes modifications intended to improve the device's performance. When it comes to software, FDA requires the submission of a new 510(k) when the change introduces a new level of risk or significantly affects functionality or performance specifications tied to the device's intended use. FDA does NOT require a new 510(k) for software changes intended to address cybersecurity. IUVO Consulting, LLC helps companies submit 510(k) pre-market notifications to FDA. To speak with us regarding your device or software, please contact us by email: 510khelp@iuvoconsulting.com or by phone (757) 514-1589.

  • GDUFA REAUTHORIZED FOR 2018

    On August 18, 2017, the Food and Drug Administration Reauthorization Act (FDARA) was signed into law, which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2022. GDUFA aims to fund FDA's generic drug program, while ensuring that consumers have timely access to safe, high-quality, affordable generic drugs. GDUFA allows FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA’s generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications. New for 2018, FDA has allowed companies and their affiliates to be grouped together and counted as a single entity for the purse of assessing the agency's program fee. FDA defines "affiliate as a business entity that has a relationship with a second business entity, if directly or indirectly, one business entity controls or has the power to control, the other business entity; or a third party controls or has the power to control both of the business entities." The program fees will be assessed in three tiers, as follows: Large (companies with 20 or more approved ANDAs); Medium (companies with between 6 and 19 approved ANDAs); and, Small (companies with 5 or fewer approved ANDAs). The GDUFA fees have been updated as follows: ANDA $171,823 Program Large $1,590,792 Medium $636,317 Small $159,079 DMF $47,829 Facility Domestic API $45,367 Foreign API $60,367 Domestic FDF $211,087 Foreign FDF $226,087 Domestic CMO $70,362 Foreign CMO $85,362 Backlog $17,434 PAS N/A (CMO="Contract Manufacturing Organization") You can find FDA's announcement in the Federal Register here: https://www.federalregister.gov/documents/2017/08/29/2017-18377/generic-drug-user-fee-rates-for-fiscal-year-2018. IUVO Consulting helps companies comply with GDUFA requirements for self-identification and fee payment. Contact ralexander@iuvoconsulting.com today for assistance.

  • U.S. FDA ANNOUNCES FY2018 USER FEES

    The #USFDA just announced its #UserFees for FY2018, and there are some MAJOR increases. If your company is planning to submit a 510(k) or de novo submission after October 1, you'll see the biggest jump in fees. To submit a #510k #PreMarketNotification, companies will pay $10,542 ($2,636 for small businesses). Moreover, there is now a fee for #DeNovoSubmissions: $93,017 ($23,254). These are major increases for businesses without small business designation, since the 510(k) was less than $5,000 in FY2017, and no fee was previously been associated with de novo submissions. Other fees for #FY2018, charged by the agency, include the following: 510(k) $10,542 $2,636 513(g) $4,186 $2,093 De Novo classification $93,017 $23,254 PMA, PDP, PMR, BLA $310,058 $77,515 panel-track supplement $232,544 $58,156 180-day supplement $46,509 $11,627 real-time supplement $21,704 $5,426 BLA efficacy supplement $310,058 $77,515 PMA annual report $10,852 $2,713 30-day notice $4,961 $2,481 IUVO Consulting, LLC helps companies comply with FDA requirements. If you need help qualifying as a FDA-recognized small business, or if you need help with a 510(k), #513g, or de novo submission, contact us today: iuvoleads@iuvoconsulting.com.

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