FDA Blacklists Third-Party Reviewer For Lying To Sponsors, Agency
The US FDA has yanked accreditation for a third-party 510(k) reviewer for lying about employing a reviewer and forging their signature. The company is also accused of lying about correspondences with the agency.
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Digital Health Roundup, August/September 2021: Record Digital Health Funding Q1-3 Of $21.3Bn, AAOS Highlights, Regulatory Updates
In this roundup of developments in digital health, we highlight the key news and announcements from August and September.
The US agency published a paper that’s based on recommendations from experts and other stakeholders on how to best let patients know their device may be vulnerable to a cybersecurity attack.
Booz Allen Hamilton’s report found that for the most part the agency has fulfilled its user fee obligations – but one major shortcoming is an unpublished digital health guidance.