August 7, 2019
Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Premarket Reports (PMRs), notices, and supplements all have associated fees to be paid to the FDA before they will review a medical device product. The 2019 Medical Device User Fee Amendments (MDUFA) are listed at 2019 MDUFA. If the FDA determines that a manufacturer is a “small business”...
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Company: Philips Medical Systems Nederlands Date of Enforcement Report: 8/7/2019 Class II PRODUCT Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 Recall Number: Z-1997-2019 REASON Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion’s automatic exposure control...
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Company: Elekta Inc Date of Enforcement Report: 8/7/2019 Class II PRODUCT Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System Recall Number: Z-2091-2019 REASON When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle,...
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Company: Mississippi Valley Reg Bld Ctr Date of Enforcement Report: 8/7/2019 Class II PRODUCT Red Blood Cells, Leukocytes Reduced Recall Number: B-0768-2019 Platelets Recall Number: B-0769-2019 REASON Blood products, collected during a software error with blood mixers, were distributed. RECALLING FIRM/MANUFACTURER Mississippi Valley Reg Bld Ctr on 8/7/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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