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Pharmaceutical Industry › 510(k) RTA › Premarket Approval Applications

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Goodwin

Modernizing the FDA’s 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k)...

Goodwin on

On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, consistency, and...more

Knobbe Martens

FDA on pace for a Record Number of Breakthrough Devices in 2023

Knobbe Martens on

The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek a breakthrough...more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

Robinson+Cole Health Law Diagnosis on

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Morgan Lewis

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

Morgan Lewis on

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

Hogan Lovells

Pilot program for 510(k) electronic submissions is requesting participants

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic submissions for 510(k) premarket notifications for medical devices other than...more

King & Spalding

FDA Issued Draft Objective Performance Criteria For Five Device Types

King & Spalding on

Implications for 510(k) Submissions - On September 20, 2019, FDA issued four separate draft guidance documents for industry and FDA administration staff that provide extensive objective performance criteria (OPC) for five...more

Arnall Golden Gregory LLP

FDA Releases Guidance on Acceptance Review for De Novo Classification Requests

Arnall Golden Gregory LLP on

On September 9, 2019, the Food and Drug Administration released a final guidance document, Acceptance Review for De Novo Classification Requests, to clarify the content that companies need to include in de novo requests to...more

Knobbe Martens

FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices....more

Hogan Lovells

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

Hogan Lovells on

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more

Polsinelli

Beware – FDA is “Modernizing” the 510(k) Program

Polsinelli on

On November 26, 2018, FDA Commissioner Scott Gottlieb, M.D. and the Director of the Center for Devices and Radiological Health, Jeff Shuren, M.D., J.D. announced FDA’s intention to take multiple actions in the near future to...more

Hogan Lovells

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

Hogan Lovells on

On 20 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren released a joint statement regarding updates to the Medical...more

Stinson LLP

FDA's Plans to Fundamentally Modernize the 510(k) Process

Stinson LLP on

FDA's "510(k)" process, by which a medical device manufacturer can bring a product to market based on the premise that the proposed device is the substantially equivalent to a an already legally marketed "predicate device",...more

Mintz - Health Care Viewpoints

FDA’s Refreshed Approach to Device Safety Would Require Major Changes to 510(k) Program

Mintz - Health Care Viewpoints on

On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety. The 510(k)...more

Hogan Lovells

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

Hogan Lovells on

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are confronted with numerous challenges. ...more

Hogan Lovells

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

Hogan Lovells on

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the historically underutilized...more

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