Alan Minsk

Alan Minsk

Arnall Golden Gregory LLP

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A Very Fine Line — Split Decision: FDA Issues Draft Guidance on Clinical Decision Support Software

From his 1986 “Back in the High Life” album, Steve Winwood sings, “It’s a fine line, a very fine line – split decision.” In fact, that’s what many medical device companies will face as they review the Food and Drug...more

11/26/2019  /  Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices

AGG Food & Drug Newsletter - October 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

10/31/2019  /  510(k) RTA , Food and Drug Administration (FDA) , Medical Devices , OPDP , Pharmaceutical Industry , Prescription Drugs

Medical Device Developments: FDA Finalizes Four 510(k) Guidance Documents

In September, the U.S. Food and Drug Administration issued multiple final guidance documents related to the medical device program. ...more

10/30/2019  /  510(k) RTA , Food and Drug Administration (FDA) , Medical Devices

FDA Considers How to Evaluate the Safety of the Materials Used in Medical Devices

On September 30, 2019, Jeff Shuren, Director of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued a statement to announce the most recent updates to the agency’s attempts to evaluate...more

10/28/2019  /  Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry

FDA Releases Guidance on Acceptance Review for De Novo Classification Requests

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

9/25/2019  /  510(k) RTA , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications

AGG Food & Drug Newsletter - August 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

8/29/2019  /  Advertising , Antitrust Litigation , Class Action , Eliminating Kickbacks in Recovery Act of 2018 (EKRA) , Food and Drug Administration (FDA) , Medical Devices , OPDP , Pharmaceutical Industry , Prescription Drugs

FDA Says a Medical Device Sterilizer’s Promotion Is Too Hot to Touch

The Food and Drug Administration, channeling Kool & The Gang’s 1979 hit, “Too Hot,” issued a Warning Letter to a medical device company that marketed a sealed sterilization container for unlawful promotion. ...more

8/28/2019  /  Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Warning Letters

AGG Food & Drug Newsletter - May 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

5/28/2019  /  Centers for Medicare & Medicaid Services (CMS) , Department of Justice (DOJ) , Drug Pricing , Food and Drug Administration (FDA) , Jazz Pharmaceuticals , Kickbacks , Medical Devices , Patient Assistance Programs , Pharmaceutical Industry , Prescription Drugs

FDA Has Not Gone Away When It Comes to Unlawful Medical Device Promotion: Companies Receive Warning Letters for Violative...

In April 2019, the Food and Drug Administration issued two Warning Letters to medical device manufacturers, reminding industry that the agency will take enforcement action against unlawful promotion when it sees fit. One...more

5/15/2019  /  Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Warning Letters

AGG Food & Drug Newsletter - April 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

4/15/2019  /  Artificial Intelligence , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry

FDA’s Steps Toward a New Review Framework for Medical Devices That Use Artificial Intelligence Algorithms

On April 2, 2019, the Food and Drug Administration issued a statement by Commissioner Scott Gottlieb on steps toward a new review framework specifically tailored to promote the development of medical devices that use...more

4/12/2019  /  Algorithms , Artificial Intelligence , Food and Drug Administration (FDA) , Health Technology , Medical Devices , Popular

Rx Drug and Medical Device Advertising & Promotion – Considerations and Predictions for 2019

AGG recently presented a webinar on “FDA Regulation of Rx Drug and Medical Device Advertising & Promotion: The Year in Review.” The webinar focused primarily on enforcement letters and three guidance documents issued by the...more

2/11/2019  /  Advertising , Food and Drug Administration (FDA) , Medical Devices , OPDP , Pharmaceutical Industry , Prescription Drugs

Medical Device Landscape: Additional Developments for the 510(k) Pathway

In 2018, the Food and Drug Administration announced several actions relevant to the 510(k) premarket notification regulatory pathway. AGG has previously written about some of these, such as the pilot expansion of the Special...more

1/29/2019  /  510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry

It’s De Novo All Over Again: FDA Issues a Proposed Rule to Implement the De Novo Classification Process

In December 2018, the Food and Drug Administration issued a proposed rule that would amend the medical device classification regulation to implement the De Novo classification process. ...more

1/23/2019  /  510(k) RTA , Draft Guidance , FDA De Novo Clearance , Food and Drug Administration (FDA) , Medical Devices

FDA Launches Pilot to Expand the Special 510(k) Program

On October 1, 2018, the Food and Drug Administration (FDA) announced a pilot expansion of the Special 510(k) Program. The Special 510(k) Program was developed to help streamline the 510(k) premarket notification process for...more

10/24/2018  /  510(k) RTA , Draft Guidance , Federal Pilot Programs , Food and Drug Administration (FDA) , Manufacturers , Medical Devices

AGG Food & Drug Newsletter - August 2018

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

8/28/2018  /  Department of Justice (DOJ) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Opioid , Pharmaceutical Industry , Prescription Drugs , Warning Letters

Talk This Way, Pt. 2

Once again channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric, “Talk This Way,” the Food and Drug Administration has issued two final guidance documents on medical product communications. These final...more

7/12/2018  /  Draft Guidance , Food and Drug Administration (FDA) , Labeling , Medical Devices , Pharmaceutical Industry , Product Labels

AGG Food & Drug Newsletter - April 2018

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

4/20/2018  /  Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry

(Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k) Program

The Food and Drug Administration channeled, in the other direction, the 1979 Supertramp song, “Take the Long Way Home,” after it issued a draft guidance entitled, “Expansion of the Abbreviated 510(k) Program: Demonstrating...more

4/19/2018  /  510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry

AGG Food & Drug Newsletter - March 2018

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

3/23/2018  /  510(k) RTA , Food and Drug Administration (FDA) , International Arbitration , Life Sciences , Medical Devices , OPDP , Pharmaceutical Industry , Prescription Drugs

AGG Food & Drug Newsletter - February 2018

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

2/23/2018  /  Excise Tax , FDAMA , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Product Recalls

FDA Issues Guidance on Submitting 510(k)s for Changes to Existing Devices

On October 25, 2017, the Food and Drug Administration (FDA) issued a final guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, which describes when a change in a medical device would...more

11/16/2017  /  510(k) RTA , Final Guidance , Food and Drug Administration (FDA) , Medical Devices , Pre-Market Notification

AGG Food & Drug Newsletter - September 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

9/21/2017  /  FDARA , Food and Drug Administration (FDA) , Medical Devices , OPDP , Opioid , Pharmaceutical Industry , Prescription Drugs , Warning Letters

You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good...more

9/20/2017  /  CGMP , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Warning Letters

AGG Food & Drug Newsletter - August 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

8/18/2017  /  Cosmetics , Department of Justice (DOJ) , False Claims Act (FCA) , Federal Pilot Programs , Food and Drug Administration (FDA) , GAO , Health Care Providers , Healthcare Fraud , Medical Devices , Opioid , Pharmaceutical Industry , Prescription Drugs , Section 340B
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