FDA Law

MARCH 7, 2024

Gibbs — Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical device submissions that require a user fee.

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Manufacturing Medical IT Provider 64

FDA Law

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. By Philip Won & Jeffrey K. Now, with explicit statutory authority, FDA’s push for cybersecurity has a firm legal footing.

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Specialization Provider Medical Manufacturing 105

FDA Law

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. So, what is special about September 24, 2023? Most of the compliance dates have been passed. Emphasis added.)

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FDA Law

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. CMS will develop a new online portal for manufacturers to review their reports, submit Suggestions of Error, and make rebate payments.

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Manufacturing Provider IT 59

FDA Law

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

DECEMBER 7, 2023

In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement. DOJ has provided few bright lines about when conversations and disclosures to FDA may also satisfy its own VSD requirements.

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Consulting Provider Manufacturing Specialization 52

FDA Law

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change. The fate of the PR is far from certain.

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Provider Manufacturing IT Medical 64

FDA Law

SEPTEMBER 3, 2024

Some other noteworthy observations: More than half (8/15) of the recently posted decision summaries were from 2023. Given the high rate of innovation in the device industry, including the evolving field of AI, we expect more manufacturers to either submit De Novo classification requests or rely on those for their 510(k) devices.

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Manufacturing Medical Provider IT 69

FDA Law

NOVEMBER 7, 2022

Refunds will still be owed for quarters beginning with 1Q 2023, and CMS will still send annual reports to manufacturers containing the number of discarded units and the refunds owed for four quarters. The requirement to use a JZ modifier where there were no discarded amounts has been delayed for six months until July 1, 2023.

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Manufacturing Government Provider 59

FDA Law

JANUARY 18, 2023

Upcoming CMS Guidance CMS provides a list of topics on which it plans to issue guidance. The Agency has promised it will provide comment periods for each guidance. They are: Terms and conditions of the manufacturer agreement, including each party’s responsibilities. Content of an explanation for the maximum fair price (MFP).

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IT Manufacturing Provider Government 59

FDA Law

SEPTEMBER 19, 2023

That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”. The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the.

Manufacturing 105

Manufacturing Provider IT Healthcare 105

FDA Law

OCTOBER 4, 2023

The court did not make much of Plaintiff’s argument that a manufacturer cannot terminate its participation in Medicare for close to two years, see Motion at 8; Complaint at 27-28, potentially dismissing it as a mere administrative matter. The drug was indeed selected on August 29, 2023. Order at 24.

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Provider Manufacturing IT Government 59

FDA Law

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance.

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Manufacturing Provider Consulting IT 64

FDA Law

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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Electronics Manufacturing Provider Medical 59

FDA Law

AUGUST 7, 2023

Through ELP, CDRH staff visit sites that provide formal training and enhance understanding on topics such as how products are developed and how they fit into the larger healthcare system. The visits are intended purely to provide a training perspective, and not for CDRH staff to opine on any regulatory functions.

Patient-Centered 40

Patient-Centered Insurance Manufacturing Provider 40

FDA Law

NOVEMBER 20, 2023

It is the latest item on a long list of similar initiatives that have marked 2023. The Agency wants to see functional, effective cultures of quality, and expects that C-suites will provide support to quality units. The changes at OPQ are the latest in FDA’s expanded 2023 quality efforts.

Manufacturing 59

Manufacturing Management IT Provider 59

FDA Law

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

Manufacturing 59

Manufacturing Provider IT 59

FDA Law

JULY 17, 2022

Currently, a health care provider identifies any discarded quantity from such a vial in the claim using a JW modifier, and Medicare Part B pays for both the utilized and the discarded amount. On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund.

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

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Management Manufacturing Supply Chain Provider 45

FDA Law

AUGUST 14, 2023

Other interesting datapoints from her presentation: For the period from FY2000 to May of 2023, the percentages of drug manufacturing inspections with OAI classifications was lower in China (about 5% of inspections) than in the United States (8%). facility inspections are approaching traditional levels.

Manufacturing 52

Manufacturing Provider IT Medical 52

FDA Law

AUGUST 27, 2023

As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. Drug manufacturers have had electronic systems in place since 2017. By Karla L.

Supply Chain 52

Supply Chain Electronics Manufacturing Provider 52

FDA Law

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

FDA Law

JUNE 22, 2023

FDA hailed its authorization of the Lucira OTC home test for influenza and COVID-19 as “underscor[ing] the Agency’s continued commitment to increase availability of accurate and reliable at-home diagnostic tests” ( April 2023 FDA Update to CDC ). seeking treatment). This makes seeking clearance of an OTC home test a risky business endeavor.

Manufacturing 59

Manufacturing Clinic IT Medical 59

FDA Law

MAY 31, 2021

One of these amendments was a poorly thought-out rule that, if implemented, will render virtually unusable the current best price exclusion for manufacturer patient savings programs in the form of coupons, patient rebates/refunds, copay assistance, vouchers, and free drug programs. The effective date of this amendment is January 1, 2023.

Manufacturing 52

Manufacturing Insurance Patients IT 52

FDA Law

FEBRUARY 15, 2023

By amending and repealing certain parts of the regulation, FDA believes that compliance to standards adequately protect public health and provide a reasonable assurance of safety and effectiveness when appropriately used by trained personnel. The final rule will be effective February 21, 2023.

Manufacturing 52

Manufacturing Electronics Medical Clinic 52

FDA Law

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”).

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Provider IT Manufacturing Complication 59

FDA Law

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. Fiscal Year 2023 showed similar performance.

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Consulting Manufacturing Utilities Provider 52

FDA Law

JUNE 17, 2024

Instead, the State of Pharmaceutical Quality Report provides more detailed statistics and data from FY2023 (October 1, 2022—September 30, 2023), and a clearer window into enforcement priorities. This report is not to be confused with OPQ’s Annual Report , a shorter and gauzier look into OPQ’s operations.

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Manufacturing IT Provider Medical 59

FDA Law

SEPTEMBER 15, 2024

2140, the Patent Eligibility Restoration Act of 2023 (“ PERA Act ”). IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Reading through the “Findings” section of S.

IT 76

IT Manufacturing Medical Provider 76

FDA Law

APRIL 3, 2023

By way of background, manufacturers are subject to an additional per-unit Medicaid rebate if they increase their prices greater than the rate of inflation. billion , respectively, in FY 2021), the impact on drug manufacturer rebates of CMS’s line extension definition, and the Court’s failure to overturn it, will be that much magnified.

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Manufacturing IT Clinic Provider 59

FDA Law

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

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Patient-Centered Manufacturing Provider Telehealth 59

FDA Law

DECEMBER 8, 2022

1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023, sesame. In addition to providing additional examples of tree nuts, the draft guidance states that FDA considers the following categories of fish to be major food allergens under Section 201(qq): Jawless fish (e.g.,

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Engineering Transportation Manufacturing Education 59

FDA Law

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted. The MDUFA V reauthorization converts the ASCA Pilot to a permanent program.

IT 52

IT Consulting Manufacturing Provider 52

FDA Law

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). Any comments to the public notice must be submitted by August 11, 2023.

Manufacturing 59

Manufacturing Utilities Electronics IT 59

FDA Law

NOVEMBER 14, 2022

The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. The facility fee applies to a single manufacturing facility. Size, revenue, and number of finished drug products manufactured at a facility do not affect the OMUFA facility fee.

Manufacturing 52

Manufacturing Individual Management Provider 52

FDA Law

JULY 18, 2023

The report reiterated a commitment to maintain the supply chain and provides more context about how OPQ—and FDA, more generally—are approaching quality and enforcement as we continue to hurtle past the COVID-19 public health emergency (PHE). That leaves 60% that manufacture at least one application product. and South Korea.

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Supply Chain Manufacturing IT Provider 52