News & Analysis as of

Reporting Requirements Medical Devices

Don’t give medical device makers more time before disclosing product woes

Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more

Proposed Legislation to Relax Rules on Medical Device Reporting Passes U.S. House

by Cozen O'Connor on

On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug...more

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

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

FDA Issues Its First Postmarketing Safety Reporting Regulations for Combination Products

Originally published in FDA Flash! Blog - February 2nd, 2017. The Food and Drug Administration (FDA) recently published a final rule setting forth the first postmarketing safety reporting regulations for combination...more

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

FDA Identifies Fifteen Hospitals with Failures to Comply with User Facility Requirements for Medical Device Reporting

by King & Spalding on

FDA issued a Form FDA 483 to fifteen prominent hospitals across the United States following inspections that demonstrated failures to comply with the user facility medical device reporting requirements pursuant to 21 C.F.R....more

MDR Reporting Final Guidance

by Reed Smith on

FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”. As with all such guidance documents, it is nonbinding: “It does not establish any rights for any person and is not binding on...more

Hospital Adverse Event Reporting System To Be Integrated Into FDA NEST Program

Based on recent FDA statements, it looks as though the FDA would like to integrate hospital medical device reporting obligations into the National Evaluation System for health Technology (NEST) framework. The NEST system is a...more

FDA Examining Role of Hospitals in Medical Device Surveillance

by Ropes & Gray LLP on

On October 25, 2016, FDA announced an upcoming public workshop entitled, “The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance.” ...more

Is your cybersecurity upgrade FDA reportable?

by DLA Piper on

In today’s marketplace, technology evolves at a rapid rate, and must adapt to changing circumstances, such as threats to cybersecurity. For device companies, some types of modifications to devices post-market - potentially...more

CMS Hosts Call on Potential Future Changes to Open Payments/Sunshine Act Reporting Requirements (Aug. 2)

by Reed Smith on

On August 2, 2016, CMS is hosting a Special Open Door Forum Call on potential future changes to Open Payments/Physician Payments Sunshine Act requirements for reporting payments and transfers of value made by drug and device...more

CMS Posts Open Payment Data – $7.52 Billion in 2015

by Tucker Arensberg, P.C. on

CMS published the 2015 Open Payment Data on June 30, 2015. CMS has presented tables in its press release showing the highest paid specialties and highest paying companies. ...more

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

by Knobbe Martens on

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure

by Cozen O'Connor on

Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more

A Lifelong Commitment: FDA Releases Postmarket Guidance on Cybersecurity Risk Management for Medical Device Manufacturers

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as...more

FDA's Expanding Views on Cybersecurity and Medical Devices: Draft Guidance on Postmarket Management of Cybersecurity

by Pepper Hamilton LLP on

Medical device manufacturers need to consider cybersecurity controls in all aspects of the product development process, from conception through commercialization. In response to concerns about increased cybersecurity...more

Connecticut Legislature Reduces Mandatory Reporting of Payments to APRNs

by Robinson & Cole LLP on

On May 11, 2015, Connecticut Governor Dannel P. Malloy signed into law Public Act 15-4, “An Act Concerning Reporting of Payments by Manufacturers to Independently-Practicing Advanced Practice Registered Nurses” (P.A. 15-4)....more

Blog: Connecticut Delays Payment Reporting Until 2017

by Cooley LLP on

Under a Connecticut law enacted in 2014, pharmaceutical and medical device manufacturers were required to begin reporting payments made to advanced practice registered nurses (APRNs) on July 1, 2015. ...more

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

by Cooley LLP on

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

by Cooley LLP on

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug,...more

CMS Publishes Guidance Regarding Reporting CME Payments Under Open Payments

by King & Spalding on

On Monday, December 15, 2014, CMS published guidance regarding pharmaceutical and medical device manufacturers’ obligations under the Open Payments requirements to report payments they provide indirectly to U.S. physicians in...more

CMS Changes Sunshine Rules for CME, Revises List of Data Elements to be Reported

by Stinson Leonard Street on

The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more

CME Payments Largely Remain Excluded From Sunshine Act Reporting

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed...more

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

by Polsinelli on

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

CMS Proposes Changes to Sunshine Act Reporting

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more

43 Results
|
View per page
Page: of 2
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.