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Latest Posts › 510(k) RTA

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UPDATE: Trump Administration’s Midnight Rulemaking to Exempt Certain Class I and II Devices from 510(k) Requirement Rescinded

In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more

4/26/2021 / 510(k) RTA , Biden Administration , Department of Health and Human Services (HHS) , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Regulatory Reform , Trump Administration

Biden Administration Halts Proposal to Exempt Some Class II Devices Currently Subject to Enforcement Discretion from 510(k)...

In one of the last proposed notices from the US Department of Health and Human Services (HHS) under the Trump administration, HHS removed the 510(k) premarket notification requirement for seven types of gloves and proposed...more

2/8/2021 / 510(k) RTA , Biden Administration , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Pre-Market Notification , Premarket Approval Applications , Regulatory Reform , Regulatory Requirements , Safety and Performance Pathway

FDA Launches eSTAR Pilot Program to Further Simplify Medical Device 510(k) Submissions

In what appears to be another electronic tool in the US Food and Drug Administration’s quest to move to full digital submissions for medical devices, the eSTAR program provides 510(k) applicants with a PDF template document...more

3/12/2020 / 510(k) RTA , Automation Systems , CDRH , Electronic Filing , FDA Approval , Federal Pilot Programs , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

10/4/2016 / 510(k) RTA , Draft Guidance , FDASIA , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Modification , Risk Management , Section 510

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