FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” By Philip Won & Jeffrey K. This provision became effective as of March 29, 2023.

Specialization 105

Specialization Provider Medical Manufacturing 105

FDA Law Blog

DECEMBER 1, 2024

The current Warning Letter was issued to a drug manufacturer in China (Tianjin Darentang Jingwanhong Pharmaceutical Co., In September 2016, Nippon Fine Chemical received a similar Warning Letter about an attempt to prevent an FDA Investigator from taking photographs.

Management 113

Management IT Manufacturing Provider 113

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. This guidance document is still in effect today.

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

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 Blog

MARCH 6, 2022

This international standard is the 2016 edition of ISO 13485, issued by the International Organization for Standardization (ISO). It is very common for a medical device manufacturing facility both to be certified as compliant with ISO 13485 and to have quality system procedures designed to comply with the FDA’s QSR.

Manufacturing 52

Manufacturing Management Medical Provider 52

FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

Manufacturing 64

Manufacturing Engineering Medical IT 64

FDA Law Blog

AUGUST 8, 2024

Rescheduling or descheduling from the most stringent schedule under the CSA, should one of those actions occur, would loosen federal manufacturing, import/export, distribution, and security requirements. 12, 2016); Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed. 53,688 (Aug. 53,767 (Aug. 21 U.S.C. §

Government 59

Government Medical IT Manufacturing 59

FDA Law Blog

SEPTEMBER 6, 2022

This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. What’s new in the new Draft Guidance? Not all that much. The new Q & As (Q21, Q22, and Q23) all concern charging in the context of expanded access.

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.

Provider 52

Provider Individual IT Manufacturing 52

FDA Law Blog

OCTOBER 20, 2021

As we have previously discussed , under the PMTA pathway, manufacturers must demonstrate that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. FDA Provides Update on Pending PMTAs. In a press release announcing the orders, Mitch Zeller, J.D.,

Provider 52

Provider Electronics Manufacturing IT 52

FDA Law Blog

JANUARY 26, 2022

Note that Allysa Seely is a Paralympian gold medal triathlete, and swimmer Ryan Murphy is a 2016 Olympian and gold medalist.) By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming!

IT 40

IT Education Utilities Patient-Centered 40

FDA Law Blog

APRIL 19, 2021

The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug. Two judges on the D.C.

Manufacturing 40

Manufacturing Government Medical IT 40

FDA Law Blog

APRIL 11, 2022

Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. A critical task in this situation is for a firm to estimate the risk posed by the issue as accurately as possible.

Medical 40

Medical Management Manufacturing Patients 40

FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The guidance provides no rationale for hinging the device status of CDS software on the frequency with which medical information is collected.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. In that letter, FDA stated that it would “permit manufacturers.

Medical 59

Medical Manufacturing Individual Provider 59

FDA Law Blog

JANUARY 18, 2024

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

Medical 69

Medical Physicals IT Healthcare Professional 69

FDA Law Blog

JUNE 24, 2021

In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ). In contrast, a device servicer is not a device manufacturer and, therefore, need not comply with the QSR.

Manufacturing 52

Manufacturing Medical Provider IT 52

FDA Law Blog

MAY 5, 2024

FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. 29, 2023). Letter to U.S. and lack accepted safety for use under medical supervision.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

FDA Law Blog

APRIL 7, 2025

Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. The detail with which CVM reviewed these promotions is reminiscent of OPDP/DDMAC letters of yore.

Vaccination 64

Vaccination IT Manufacturing Screening 64

FDA Law Blog

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Physicals 69

Physicals Medical Clinic Emergency Room 69

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. Several commercial laboratories are providing this service including Quest, LabCorp, ARUP and Mayo.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

FDA Law Blog

AUGUST 10, 2021

The idea of basing Medicare drug reimbursement on prices in foreign countries was first proposed during the Obama Administration in 2016. Use of international reference pricing as a target for Medicare to negotiate prices with drug manufacturers appears in H.R. The Trump Administration rule had a troubled history. 3 , the “Elijah E.

Finance 52

Finance Insurance Manufacturing IT 52

FDA Law Blog

SEPTEMBER 14, 2021

The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law Blog

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law Blog

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

Medical 59

Medical Manufacturing Patient-Centered Provider 59

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate. Last Thursday, the U.S.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98