Hogan Lovells Publications

FDA delays draft rule for QSR/ISO 13485 harmonization Medical Device Alert

25 November 2019

The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020.

Hogan Lovells Publications

Appealing a denial of a drug/medical device export certificate: FDA final guidance Medical Device Alert

19 November 2019

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign...

Hogan Lovells Publications

Harmonizing cybersecurity for medical devices: International collaboration moves forward Medical Device Alert

09 October 2019

On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical ...

Hogan Lovells Publications

FDA addresses industry feedback on routine inspections by formalizing processes and standards in a draft guidance Medical Device Alert

04 April 2019

On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection...

Hogan Lovells Publications

FDA statement underscores continued emphasis on use of real-world evidence in active postmarket device surveillance Medical Device Alert

29 November 2018