The Supreme Court just limited federal power. Health care is feeling shockwaves - Health News Florida

Updated September 22, 2025

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Supreme Court Decision Limiting the Authority of Federal Agencies Could Have Far-Reaching Impacts for Health Policy (KFF):  https://www.kff.org/private-insurance/supreme-court-decision-limiting-the-authority-of-federal-agencies-could-have-far-reaching-impacts-for-health-policy/

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According to the article:

"The ruling will likely have seismic ramifications for health policy.

A flood of litigation — with plaintiffs like small businesses, drugmakers, and hospitals challenging regulations they say aren’t specified in the law — could leave the country with a patchwork of disparate health regulations varying by location."

"Health policy leaders say patients, providers and health systems should brace for more uncertainty and less stability in the health care system. Even routine government functions such as deciding the rate to pay doctors for treating Medicare beneficiaries could become embroiled in long legal battles that disrupt patient care or strain providers to adapt."

Read the full source article:   The Supreme Court just limited federal power. Health care is feeling shockwaves - Health News Florida

FDA Running At Reduced Capacity - Government Shutdown

Government Shutdown Leaves FDA Operating at Reduced Capacity, But User Fees Act as Agency Savior:

" . . . Steven Immergut, another FDA spokesman, who elaborated on the practical effects of the shutdown.

The facts and figures are stark: 45% of the agency's staff is not permitted to work until funding is provided. Nearly 75% of FDA staff remaining on the job are funded through industry-paid user fees, otherwise they would likely be furloughed as well. It was not immediately clear if they would receive pay at the usual intervals."

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FDA - Final MDDS Rule - Federal Register Full-Text

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Updated August 7, 2023:

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MDDS Rule - a webpage on FDA.gov

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The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements. This rule is effective April 18, 2011.

Read the full-text of the MDDS rule in the Federal Register [Volume 76, Number 31 (Tuesday, February 15, 2011)].

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FDA Issues MDDS Final Rule

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Updated March 11, 2021

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FDA finalizes regulation for certain software, hardware used with medical devices - Rule provides more predictable path to market.

The FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification. Examples of MDDS products include: devices that collect and store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed at a nursing station for future use.

Here's a thought-provoking article, Final MDDS rule deems hospitals medical device manufacturers. In this article, it mentions, "The final MDDS rule will apply to “all manufacturers,” the FDA says. Critically, this includes hospitals, health care facilities or any other organization that does any of the following: . . ."

As of this writing, the Medical Device Data Systems rule will be published in the Federal Register. Read the rule here: Medical Devices; Medical Device Data Systems - FDA Final Rule (PDF).

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FDA Releases Proposed Guidance On Combination Products

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Updated July 5, 2024:

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FDA - Combination Products Guidance Documents

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This Federal Register notice announces the FDA release of a proposed rule on combination products, Current Good Manufacturing Practice Requirements for Combination Products (pdf). According to the FDA Law Blog post, FDA Issues Proposed Rule on cGMPs for Combination Products:

The proposed rule does not independently establish new requirements, rather, it clarifies which set of existing cGMP regulatory requirements apply when drugs, devices, and biological products are combined to create a combination product.

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FDA Says You Only Have 15 Days To Respond To Form 483

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Updated September 7, 2021

The links broke in the original post.

You can still read about the topic here:

The Emergency Guide To FDA Warning Letters & FDA 483. How to handle inspectional observations and warning letters from the FDA. A White Paper by The FDA Group LLC.

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According to this PharmTech article, FDA Begins Enforcing Deadlines on Form 483 Responses, you have only 15 days to respond to a form 483. Be aware, this article states:

Now, however, FDA “will not ordinarily delay the issuance of a warning letter in order to review a response to an FDA 483 that is received more than 15 business days after the FDA 483 was issued,” according to an announcement in the Federal Register.

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HIV AIDS Update - Obama strategy and more (podcast)

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Listen to Ernest Hopkins, the San Francisco AIDS Foundation's Director of Federal Affairs, as he talks about the Obama administration's progress on the National AIDS Strategy, the recent White House reception with LGBT leaders on the 40th anniversary of the Stonewall riots and the progress being made toward lifting the US ban on HIV-positive foreign travelers, in this podcast, SFAF.org Podcast #58 - A Federal HIV/AIDS Update with Ernest Hopkins. 

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FDA Regulated Businesses - Will you be compliant with the new FTC rule?

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If you're in the FDA regulated industries, you might want to pay attention to the FTC's new rule according to this Casetext post, August 1, 2009 - FTC’s New Identity Theft Rule Probably Requires You To Comply. In a nutshell, Koustas & Fleder say:

Given the apparent reluctance of the FTC to create exemptions from this regulation, most companies regulated by FDA must determine if the Rule applies to them. If the answer is yes, there is an August 1, 2009 deadline fast approaching to develop and implement a compliance plan. Failure to comply may subject the entity to administrative enforcement action by FTC as well as civil liability to consumers.

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Drugs - Devices - Preemption - Explained Clearly

My hat is off to Matt Hotz, on the Pharma Compliance Blog, for writing this succinct and consumable post that even I can understand, Preemption and the Distinction between Drugs and Devices. I'm not a lawyer, so I've found this particular topic difficult to digest. Hotz' post got me up to speed quickly and expanded my understanding of the touchpoints to local, state, vs. federal law; and to the distinctions and nuances between drugs vs. medical devices. Now I feel that I can follow breaking preemption news with some basic foundational understanding. Thanks Matt! 

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FDA Publishes Rulemaking Histories For OTC Drugs

If you're in the Over-The-Counter (OTC), non-prescription drug business, then this FDA collection might be of some interest to you: Rulemaking History for Nonprescription Products: Drug Category List. The Over-the-Counter (OTC) drug category collection contains Federal Register notices organized by therapeutic category subtopics. Each child collection links to therapeutic category pages organized chronologically. Pretty nice. For example, you can scan the Federal Register history for something like, Hair Growth and Loss, Male Genital Desensitizers, or Weight Control. 

Related Posts: FDA Warning - Anesthetics On Skin Can Harm FDA Alert - Bowel Cleanser Warning Cold Meds For Kids - The FDA Weighs In Again 

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FDA Makes Zometa Inj Orange Book Decision

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Updated Dec 17, 2020
It's here! The latest Orange Book Annual Edition

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FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations


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The Food and Drug Administration (FDA) has determined that ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams (mg) base/vial, lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for zoledronic acid lyophilized powder for injection, 4-mg base/vial. The Federal Register published the FDA docket "Determination That ZOMETA (Zoledronic Acid for Injection), Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (pdf)."

According to IP Pharma Doc's post, Zoledronic acid (ZOMETA) lyophilized powder for injection: USFDA confirmed that drug was not withdrawn due to safety issues, this decision will allow US FDA to approve ANDA's for the innovator's (Novartis) discontinued product (in May, 2003).

Kurt Karst posts an in-depth analysis and commentary related to the FDA decision, Attention Orange Book Junkies: FDA Petition Response Cements Orange Book Preface Therapeutic Equivalence Clarification.

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FDA Enforced Laws And Related Statutes

Updated June 28, 2025

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Laws Enforced by FDA - FDA.gov

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Since this blog covers "GMPs (FDA Good Manufacturing Practices) and other regulations," I guess it's only fair to devote a post to the FDA's "Laws Enforced by the FDA and Related Statutes." They post a pretty exhaustive list of laws and statutes, which they categorize in the following way . . .

Federal Food, Drug, and Cosmetic Act (FD&C Act) United States Code (U.S.C.) Title 21, Chapter 9 Cross-reference of FD&C Act and U.S. Code section numbers Amendments to the FD&C Act Other Laws

It should be noted that some of the laws may have been amended since their original date.

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Code of Federal Regulations (CFRs) Available Online (free) - Go Green!

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Updated March 8, 2022

This is a wonderful use of our tax dollars. Go green and stop buying hardcopies of the CFRs. You can slice and dice, search, and browse published CFRs. And if you just can't help yourself, you can always print pertinent text or save portions offered as pdf files. Here's just a sampling of the different ways you can use this site . . .

1. Listing of all CFR Titles, 1-50 
2. 21 CFR Food and Drugs - includes Parts 1 to 1499 (for Parts 210 & 211)

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