Modification

News & Analysis as of

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

When Is a Software Change Really a Change that Requires FDA Review?: When to Submit a 510(k) for a Software Change to an Existing...

On the same day the Food and Drug Administration issued its revised draft guidance document on when to submit a new 510(k) premarket notification for an existing medical device, it released a similar document specific to...more

Insurer Can Breach Duty by Refusing to a Modification of a Release

Insurer Can Breach Duty by Refusing to a Modification of a Release Woodland hills personal injury lawyer Barry P. Goldberg analyzes insurance company obligations particularly involving ‘Releases.” Mr. Goldberg recently...more

FDA Releases Revised Guidance on Device Modification Policy

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft...more

When It’s Time to Change, You’ve Got to Rearrange: FDA Issues Draft Guidance on When Changes to an Existing Medical Device...

Many of us remember the classic 1972 Brady Bunch song, “Time to Change,” when Peter Brady sings (as his voice cracks), “When It’s Time to Change, You’ve Got to Rearrange,” channeling its inner Brady, the Food and Drug...more

FDA Issues Proposed Guidance for Changes to Medical Device Software

The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software...more

UK Prudential Regulator Publishes Statement on the Leverage Ratio

The Prudential Regulation Authority published a statement inviting firms to apply for a temporary modification of the application of the Leverage Ratio, Public Disclosure and Reporting Leverage Ratio parts of the PRA Rulebook...more

FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices

On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff determine whether a new premarket notification (510(k)) is required upon...more

Misinterpreting the Law Doesn’t Negate an Alimony Agreement

The Appeals Court decision in DeMarco v. DeMarco reminds us that a deal is a deal, even when it’s entered into based upon advice from a trial judge who misinterprets the law....more

Game Over, Man! Bankruptcies Trump Ongoing Obligations under Expired CBAs

On May 31, 2016, the Supreme Court denied the cert. petition of Unite Here Local 54, Atlantic City’s largest casino workers’ union, which challenged a Third Circuit decision affirming a Delaware Bankruptcy Court decision that...more

Dieckman v. Regency GP LP, et al., C.A. No. 11130-CB (Del. Ch. Mar. 29, 2016) (Bouchard, C.)

In this opinion, the Delaware Court of Chancery reaffirmed that default fiduciary duties, including a duty of disclosure, may be modified or wholly eliminated when such modification or elimination is clearly set forth in a...more

Delaware Chancery Court Dismisses Challenge to Merger of MLPs - Reaffirms Ability of Limited Partnerships to Modify Fiduciary...

In an opinion issued on March 29, 2016, the Delaware Chancery Court dismissed a challenge to the 2015 acquisition of Regency Energy Partners LP (“Regency”) by Energy Transfer Partners L.P. (“ETP”), holding that Regency’s...more

Trying to Outhustle a Permanent Injunction (LFP IP, LLC v. Hustler Cincinnati, Inc.)

Addressing the issue of modifying a permanent injunction for trademark infringement, the Court of Appeals for the Sixth Circuit held that an injunction may be modified if it is no longer “achieving its principal objects,” due...more

D.C. District Court to Clean Up Indian Farmers and Ranchers Class Action

After years of post-settlement wrangling in a class action lawsuit brought by Native American farmers and ranchers for damages arising from what they claimed was systemic discrimination against them by the U.S. Department of...more

Appellate Court Notes

Supreme Court Advance Release Opinions: - SC19165 - Dept. of Transportation v. White Oak Corp. - SC19165 Dissent - Dept. of Transportation v. White Oak Corp. Despite a very convoluted history, the essence of...more

Deadlines Fast Approaching to Modify Groundwater Basin Boundaries Under New Regulation

Under the recently enacted Sustainable Groundwater Management Act (SGMA), groundwater basins defined by Bulletin 118 are the default regulatory units for sustainable groundwater management. (See Water Code § 10722.) But...more

To Void Or To Modify? Courts Have The Final Say On Voiding Or Rewriting A Non-Compete Agreement

“This has been a trend for a long time; the days of lifetime employment are long since over.” — Marc Andreeson Anticipating that employees do not always stay with an employer for the duration of their careers,...more

Appellate Court Notes

Supreme Court Advance Release Opinions: SC19253 - RBC Nice Bearings, Inc. v. SKF USA, Inc. [An important decision on contract waiver but one all attorneys should recall from the UCC or Contracts course we took...more

Civil Code Reform: New Provisions on Contracts and Obligations

On 8 March 2015, the President signed Federal Law No. 42-FZ "On Amending Part 1 of the Russian Civil Code." The amendments aim at increasing the stability and predictability of contractual relations under Russian law at...more

What does "will be insured" actually mean?

Balancing obligations to provide health and life insurance benefits to retirees with other legitimate business needs can be tricky. Although retirees depend on the benefits, employers may need to modify benefit plans for...more

Changes To Loan Notes: Good Faith Not Implied

In Dennis Edward Myers & anr v Kestrel Acquisitions Ltd & ors [2015] EWHC 916 (Ch), 31 March 2015, the High Court refused to imply an obligation of good faith into a term allowing modifications of loan notes. ...more

Does Rule 23(e) Require that Settlement Class Members Receive Notice of Modification to Cy Pres Remedy?

The United States District Court for the District of Columbia recently held that a modification to a settlement agreement was not subject to the procedural protections of Federal Rule of Civil Procedure 23(e) because it would...more

USPTO Announces Immediate Changes to AIA PTAB Page Limits

Responding to feedback from petitioners and patent owners, the USPTO disclosed a plan to revise the procedural rules governing post grant proceedings under the Leahy-Smith America Invents Act (“AIA”). USPTO Director Michelle...more

Post-grant proceedings after the America Invents Act

The America Invents Act (AIA) was passed several years ago. One of the biggest changes it made to the patent landscape was the options for modifying a patent after it was granted by the U.S. Patent & Trademark Office. Prior...more

Virginia General Assembly Addresses Fourth Circuit Decision to Uphold Statutory Cap on Recovery by Public Works Contractors for...

In Carnell Construction Corp. v. Danville Redevelopment & Housing Authority, 745 F.3d 703 (2014), the United States Court of Appeals for the Fourth Circuit upheld the trial court’s ruling that, without government approval,...more

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