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New European Medical Device Regulation 2017/745 Date of Application (26 May 2020) looming large

European authorized representatives and others have recently cited an apparent lag in medical device manufacturer preparedness for the new European Medical Device Regulation 2017/745.  ComplianceAcuity has always been on the cutting edge of organic compliance with European device requirements, with its Principal one of the inaugural small group of individuals in the world to achieve the European Union Regulatory Affairs Certification (EU RAC). Please contact us for more information on how we may be able to help you complete your transitions by the deadline.

ISO 13485:2016 Deadline nearly upon us…

The three-year transition period of ISO 13485:2016, “Medical Device – Quality Management Systems – Requirements for regulatory purposes” will conclude on February 28, 2019. Specifically, organizations’ ISO 13485:2003 certificates will no longer be valid as of March 1, 2019. ComplianceAcuity clients have already achieved multiple transitions to ISO 13485:2016 with ComplianceAcuity’s help and leading transitional tools and resources. Please contact us for more information on how we may be able to help you complete your transitions by the deadline.


10.16.2018
U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity…

Links to the draft guidance and corresponding Federal Register notice are provided below:

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM623529.pdf


https://www.federalregister.gov/documents/2018/10/18/2018-22697/content-of-premarket-submissions-for-management-of-cybersecurity-in-medical-devices-draft-guidance

Final draft of New ISO 13485 Medical Devices Quality Management System Standard published…

For several years ISO 13485:2003 (which is the heart of BS EN ISO 13485:2012) has been under revision. After incorporation of numerous comments and feedback from many international stakeholders, a final draft of the standard has now been released by ISO Technical Committee 210. It is expected that the final standard will be published in spring 2016.

The changes aim to more holistically address the entire medical device lifecycle and supply chain. Some key points of emphasis include supplier controls, quality feedback processes, software controls, integration of risk management in the QMS, clarifications of design verification and validation, and general harmonization with regulatory requirements.

FDA DRAFT guidance for animal studies of medical devices…

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “General Considerations for Animal Studies for Medical Devices.” FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The intent of this draft guidance is to provide a reference of best practices for the approach to, and conduct of, animal studies, and the presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience (e.g., to support an investigational device exemption (IDE) application) or to demonstrate device safety in support of a marketing application, while incorporating modern animal care and use strategies. This draft guidance is not final nor is it in effect at this time. Submit either electronic or written comments on the draft guidance by January 12, 2016. Link to the federal register notice below:

http://www.gpo.gov/fdsys/pkg/FR-2015-10-14/pdf/2015-26055.pdf

FDA updates guidance for its 510(k) Refuse to Accept Policy…

FDA released updated guidance addressing its screening acceptance process for 510(k) notifications. FDA has also made corresponding changes to the associated ‘Acceptance Checklist for 510(k)s’.

The revised guidance provides updates explaining the current procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. The new guidance is effective on October 1, 2015 and supersedes three predecessor documents from 1993, 1994, and 2012. Links to the revised guidance and updated checklists are provided below:

 

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.pdf

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm071360.htm

FDA DRAFT guidance distinguishing device recalls from enhancements…

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.” This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and identify the reporting requirements for both recalls and product enhancements. The draft guidance is not final nor is it in effect at this time. Submit either electronic or written comments on the draft guidance by May 23, 2013. Link to federal register notice here.

FDA announces availability of e-submission process for requesting CDRH export certificates…

On January 22, FDA announced via Federal Register the availability of an electronic submission process for requesting export certificates for products regulated by FDA’s Center for Devices and Radiological Health (CDRH). The e-process is aimed to help meet certain requirements set out by the FDA Export Reform and Enhancement Act of 1996 and other FDA requirements.