October 2018 updated 2020 New European Medical Device Regulation 2017/745 Date of Application 26 May 2021 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 […]
October 2018 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 […]
October 2015 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 […]
October 2015 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “General Considerations for Animal Studies for Medical Devices.”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 […]
September 2015 For updates from the European Commission regarding revision of the European MDD, click the link below: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm
August 2015 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 […]
February 2013 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.” This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and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 […]
January 2013 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 […]
January 2013 If you’ve had your FDA medical device submission e-copy rejected recently by FDA, you’re probably not alone. When firms submit the mandatory e-copy of their medical device submissions, FDA now requires the e-copy to conform to a mind-boggling array of specifications. Here are links to FDA’s corresponding Federal Register announcement and guidance document.
December 2012 Link to FDA press release.