Newsletter Articles

December 2017: FDA Finalizes UDI Guidance

December 2017: Industry Feedback Brings MDSAP Changes

December 2017: FDA Finalizes Guidance on De Novo Submission & Review Process

December 2017: AlvaMed Welcomes New Team Members


September 2017: CDRH Clarifies Process for Consensus Standards Recognition Requests

September 2017: FDA to Issue New Policies to Streamline Generic Reviews in 2017

September 2017: Healthcare of the Future: Wearable Technology and Mobile Health Devices

September 2017: Tips on How to be Prepared for an FDA Inspection


June 2017: Common MDR Questions Answered

June 2017: Australia Considers Allowing Devices Approved Overseas to be Marketed

June 2017: Proposed Bipartisan Bill to Streamline 510(k) Process

June 2017: Reauthorization of User Fee Agreement

June 2017: FDA Considering Modernizing Combo Product Regulations


March 2017: Postmarketing Safety Reporting for Combination Products

March 2017: Medical Device Regulations Update


December 2016: 21st Century Cures Act

December 2016: Deciding When to Submit a 510(k) for a Change to an Existing Device

December 2016: MEDDEV 2.7/1 revision 4 – Changes to Clinical Evaluation Reports for Medical Devices in Europe


August 2016: Recent European Developments

August 2016: Recent FDA Guidances

August 2016: ISO 13485:2016 & ISO 9001:2015 Risk-Based Thinking

August 2016: Unique Device Identification (UDI) Requirements


June 2016 Press Release: Unique Services for Small High Growth Clients

June 2016: 2015 FDA Form 483 Observations

June 2016: AlvaMed’s Part 11 Compliant Document Management

June 2016: European Union’s New Medical Device Regulation