The IRS and Treasury Department released a proposed rulemaking addressing the 2.3% excise tax imposed on medical device sales. The proposal defines taxable devices, provides an exemption for retail purchases, and outlines how existing manufacturer tax rules apply. A public hearing will be held in May to discuss the proposal, which does not address all raised issues such as treatment of vertically integrated companies. Medical device companies should analyze which products are taxable and comment on the proposal.
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
Laws Regulating Drugs and Medical DevicesAshish vishal
This is the umbrella legislation which deals with regulation of drugs and medical devices in India. It is from Section 12 of this Act that the Central Government derives the power to make rules and as a result the Drugs and Cosmetics Rules, 1945 were formulated. https://www.rickychopra.co/
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
Laws Regulating Drugs and Medical DevicesAshish vishal
This is the umbrella legislation which deals with regulation of drugs and medical devices in India. It is from Section 12 of this Act that the Central Government derives the power to make rules and as a result the Drugs and Cosmetics Rules, 1945 were formulated. https://www.rickychopra.co/
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
Pharmaceutical industries invest billions of dollars, Euros in these highly risky health care solutions, for this Intellectual property protection is essential. Innovator company enjoys a period of "data exclusivity" during which their pre-clinical and clinical trials data may not be referenced in the regulatory filings of another company for the same drug substance.
Federal Regulatory Issues Us Food And Drug Administration Medical Device Amen...Jacobe2008
Authors:
Harvard-MIT Division of Health Sciences and Technology HST.535: Principles and Practice of Tissue Engineering Instructors: Myron Spector
Massachusetts Institute of Technology
Harvard Medical School Brigham and Women's Hospital VA Boston Healthcare
FDA Regulation of Combination ProductsMichael Swit
Overview of FDA regulation of combination products -- those featuring a drug and a device, a device and a biologic, or a biologic and a drug. Reviews key issues such as Primary Mode of Action, Requests for Designation, and how to handle GMPs and Adverse Event Reporting for combination products.
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
Pharmaceutical industries invest billions of dollars, Euros in these highly risky health care solutions, for this Intellectual property protection is essential. Innovator company enjoys a period of "data exclusivity" during which their pre-clinical and clinical trials data may not be referenced in the regulatory filings of another company for the same drug substance.
Federal Regulatory Issues Us Food And Drug Administration Medical Device Amen...Jacobe2008
Authors:
Harvard-MIT Division of Health Sciences and Technology HST.535: Principles and Practice of Tissue Engineering Instructors: Myron Spector
Massachusetts Institute of Technology
Harvard Medical School Brigham and Women's Hospital VA Boston Healthcare
FDA Regulation of Combination ProductsMichael Swit
Overview of FDA regulation of combination products -- those featuring a drug and a device, a device and a biologic, or a biologic and a drug. Reviews key issues such as Primary Mode of Action, Requests for Designation, and how to handle GMPs and Adverse Event Reporting for combination products.
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
Medical Device Development Firm Glossary of terms and abbreviations.pdfAlexander Sprauve
Speck Design is a top medical device design company and engineering company. We offer end-to-end design services to develop medical products and have extensive experience researching, prototyping, designing, and bringing new medical devices to market. We also have expertise in reimagining existing medical devices for new or improved usage.
Our teams work to offer medical device design and development services, including industrial design, mechanical and electrical engineering, and setting up, running, and maintaining medical quality systems. Our approach is always human-centric, applying our human-centered design-thinking to the process to come up with creative, empathetic solutions in medical device design, product engineering, regulatory compliance, user research, and more. Throughout the last 20+ years, we have done design, engineering, and development across a vast set of medical devices and categories, including:
- Drug delivery devices
- Handheld surgical devices
- Patient monitoring devices
- Diagnostic medical devices
- Digital interface design for medical devices
- Medical device user research
- Home health care devices
As a top medical device design firm our work also includes life sciences projects such as product definition, technology roadmap discovery, future concept development, interface design, user research design, usability testing, engineering development and verification, design for CLIA certification, proof of concept prototyping, beta prototyping, ISO 13485 certified, FDA compliance, and intellectual property support.
Learn more about us here: https://www.speckdesign.com/markets/medical-device-design-company
HIGHLIGHTED: Dissemination of Patient-Specific Information from Devices by De...NextWorks
This is the highlighted version of FDA's Guidance for Industry: Dissemination of Patient-Specific Information from Devices by Device Manufacturers from June 2016.
When these guidances come out, I typically go through them and highlight the most relevant portions for those who need to skim through or refresh their memory.
Laws regulating drugs and medical devices Ashish vishal
India has the 4th largest market for drugs and medical devices in Asia. The industry has been predicted to grow to be a $ 50 billion industry in less than 5 years by 2025.
Determining if Your Product is a Medical DeviceEMMAIntl
It may seem straightforward to determine if a product is a medical device or not but there is a surprising amount of gray-area in the field. The term “medical device” covers a simple tongue depressor to an implanted pacemaker and everything in between. A simple wooden stick is one product-development decision away from either being a popsicle stick, or a tongue depressor that crosses into a strict world of regulatory requirements...
Generic Drug Labeling Proposed Rule: The Generic Drug Industry PerspectiveMichael Swit
May 15, 2014 webinar sponsored by the Drug Information Association (DIA) on the November 2013 FDA proposed rule to require generic drug firms to amend their labels with new safety information even if the brand name label has not been changed with the same information.
The basics of medical device labeling usa fda regulations-by-costas-chantzisCostas Chantzis
The Basics of Medical Device Labeling - USA FDA Regulations:
What You Must Know To Improve Your Chances of NOT Getting Your Company In Trouble with the FDA ...
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Center for Devices and Radiological Heath
Office of Communication, Education and Radiation Programs
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Watson Megatech, Inc.
% Chad Watson
Dec 1, 2011
President and CEO
5800 Industrial Blvd
Suite 11
Omaha, NE 68135
Re: P091462
BioBanking
Filed: Jan 9, 2010
Amended: August 5, September 8 and 13, 2010; February 22, 2011; September 22, 2011; October 6, 2011 and November 1, 2011.
Procode: RLD
Dear Mr. Watson:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration
(FDA) has completed its review of your premarket approval application (PMA) for the BioBanking Device.
BioBanking is intended to be for sub-dermal use as a radio frequency (RF) emitter in the prevention of identity theft and financial fraud. The device will interact with external scanners through radio frequency to identify the individual as well as financial account information. The device will also interact with external encoders for the purposes of addition or removal of financial account information. The device is solar powered and does not need internal batteries that would provide potential medical issues in the PMA review process.
The BioBanking insertion process can be administered by non-medical personnel trained in the implementation of the product. Financial institution personnel responsible for this administration will be trained and certified in application of the BioBanking device.
The sub-dermal BioBanking device is one element of the total transaction system. There is also a reader for the RF signals. Since the reader is a passive device it does not fall under provisions of the CDRH purview.
We are pleased to inform you that the PMA is approved. You may begin commercial distribution
of the device in accordance with the conditions of approval described below. You may continue
commercial distribution of the device upon receipt of this letter.
Page 2 – Mr. Watson
The sale and distribution of this device are governed by The Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) located in Sections 531 through 542 of the Act. They apply to any "electronic product" which is defined as: any manufactured or assembled product (or component, part, or accessory of such product) which, when in operation,
i. contains or acts as part of an electronic circuit and
ii. emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.
"Electronic product radiation" is defined as:
i. any ionizing or non-ionizing electromagnetic or particulate radiation, or
ii. any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.
The device is restricted under section 515(d)(l)(B)(ii) o.
American University International Law Review Annual Symposium: Managing the G...Patton Boggs LLP
DC Partner Frank Samolis will address participants during a symposium hosted by American University’s Washington College of Law on February 18, 2014. The event will examine issues around international trade and the environment through dialogue on the Trans-Pacific Partnership and Transatlantic Trade and Investment Partnership negotiations, the state of Article XX of the General Agreement on Tariffs and Trade, enforcement mechanisms under regional trade agreements, and potential future means of protecting the environment through International Trade Law Society. Mr. Samolis will serve as a panelist during a discussion on TTP talks and TTIP negotiations at 12:45 p.m. during the symposium.
With increasing demand on limited public resources, national and local governments are recognizing the need for a new approach to social services that emphasizes the identification of effective, innovative ideas. However, a lack of available funding and the reluctance to take on the risk that a promising, but unproven, idea might fail have created obstacles to this new approach. The social impact bond model is designed to eliminate these obstacles.
An astonishing, first-of-its-kind, report by the NYT assessing damage in Ukraine. Even if the war ends tomorrow, in many places there will be nothing to go back to.
03062024_First India Newspaper Jaipur.pdfFIRST INDIA
Find Latest India News and Breaking News these days from India on Politics, Business, Entertainment, Technology, Sports, Lifestyle and Coronavirus News in India and the world over that you can't miss. For real time update Visit our social media handle. Read First India NewsPaper in your morning replace. Visit First India.
CLICK:- https://firstindia.co.in/
#First_India_NewsPaper
31052024_First India Newspaper Jaipur.pdfFIRST INDIA
Find Latest India News and Breaking News these days from India on Politics, Business, Entertainment, Technology, Sports, Lifestyle and Coronavirus News in India and the world over that you can't miss. For real time update Visit our social media handle. Read First India NewsPaper in your morning replace. Visit First India.
CLICK:- https://firstindia.co.in/
#First_India_NewsPaper
El Puerto de Algeciras continúa un año más como el más eficiente del continente europeo y vuelve a situarse en el “top ten” mundial, según el informe The Container Port Performance Index 2023 (CPPI), elaborado por el Banco Mundial y la consultora S&P Global.
El informe CPPI utiliza dos enfoques metodológicos diferentes para calcular la clasificación del índice: uno administrativo o técnico y otro estadístico, basado en análisis factorial (FA). Según los autores, esta dualidad pretende asegurar una clasificación que refleje con precisión el rendimiento real del puerto, a la vez que sea estadísticamente sólida. En esta edición del informe CPPI 2023, se han empleado los mismos enfoques metodológicos y se ha aplicado un método de agregación de clasificaciones para combinar los resultados de ambos enfoques y obtener una clasificación agregada.
01062024_First India Newspaper Jaipur.pdfFIRST INDIA
Find Latest India News and Breaking News these days from India on Politics, Business, Entertainment, Technology, Sports, Lifestyle and Coronavirus News in India and the world over that you can't miss. For real time update Visit our social media handle. Read First India NewsPaper in your morning replace. Visit First India.
CLICK:- https://firstindia.co.in/
#First_India_NewsPaper
‘वोटर्स विल मस्ट प्रीवेल’ (मतदाताओं को जीतना होगा) अभियान द्वारा जारी हेल्पलाइन नंबर, 4 जून को सुबह 7 बजे से दोपहर 12 बजे तक मतगणना प्रक्रिया में कहीं भी किसी भी तरह के उल्लंघन की रिपोर्ट करने के लिए खुला रहेगा।
2024 is the point of certainty. Forecast of UIF experts
Regulations on Medical Device Excise Tax Proposed; Opportunities for Comment
1. February 7, 2012 Regulations on Medical Device Excise Tax Proposed;
Opportunities for Comment
TAX POLICY CLIENT ALERT
On Friday, February 3, 2012 the Internal Revenue Service and Department of the
This Alert provides only Treasury (Treasury) released a Notice of Proposed Rulemaking (NPRM) on the excise tax
general information and imposed on the sale of certain medical devices under section 4191 of the Internal
should not be relied upon as Revenue Code (Code). Code section 4191 imposes a 2.3 percent excise tax on the sale of
legal advice. We would be taxable medical devices by a manufacturer or importer after December 31, 2012. Section
pleased to discuss our
4191(b)(1) provides that a “taxable medical device” is any device, as defined in section
experience and the issues
201(h) of the Federal Food, Drug, and Cosmetic Act (FFDCA), intended for humans.
Section 4191(b)(2) provides that the term “taxable medical device” does not include
presented in this Alert with
eyeglasses, contact lenses, hearing aids, and any other medical device determined by the
those contemplating
Secretary of the Treasury to be of a type that is generally purchased by the general public
investments in these markets. at retail for individual use.
For more information, contact
your Patton Boggs LLP The NPRM includes proposed regulations addressing many, but not all, of the key issues
attorney or the authors listed raised by the medical device industry and other stakeholders. The preamble reviews the
below. proposed regulations and describes how existing rules for manufacturers excise taxes
apply to the sale of medical devices by manufacturers and importers.
Rosemary Becchi
202-457-5255 The NPRM announces a public hearing to be held at 10 a.m. on May 16, 2012, and the
rbecchi@pattonboggs.com NPRM seeks written or electronic comments on the NPRM, and presentation outlines to
be discussed at the public hearing, by May 7, 2012 (90 days after publication of the NPRM
George Schutzer
202-457-5273
in the Federal Register.)
gschutzer@pattonboggs.com
The NPRM incorporates both Food and Drug Administration (FDA) and IRS concepts, and
Darryl Nirenberg includes cross references to the FFDCA, FDA regulations, and manufacturers excise tax
202-457-6022 regulations.
dnirenberg@pattonboggs.com
Paul Rubin Definition of Taxable Medical Device
202-457-5646
prubin@pattonboggs.com The Code and proposed regulations define a “taxable medical device” as any device, as
Martha Kendrick
defined in section 201(h) of the FFDCA, that is intended for humans. The proposed
202-457-6520 regulations state that this means “a device that is listed as a device with the FDA under
mkendrick@pattonboggs.com section 510(j) of the FFDCA and 21 CFR Part 807.” If the FDA determines that a device
that is not listed should have been listed, the proposed regulations would treat the device
as listed as of the date the FDA notifies the manufacturer or importer that corrective action
WWW.PATTONBOGGS.COM
is required.
The proposed regulations indicate that devices intended exclusively for use in veterinary
medicine are not taxable medical devices, and that devices intended for both human and
veterinary use are taxable medical devices.
2. Retail Exemption
Under the proposed regulations, a “facts and circumstances” test would be used to
determine if a device would be considered to be of a type generally purchased at retail for
individual use. Specifically, the NPRM provides that a device would be subject to the retail
exemption “if it is regularly available for purchase and use by individual consumers who
are not medical professionals, and if the design of the device demonstrates that it is not
primarily intended for use in a medical institution or office or by a medical professional.”
Factors suggesting that a device would be subject to the retail exemption include the
following:
• “Consumers who are not medical professionals can purchase the device through
retail businesses that also sell items other than medical devices, such as drug
stores, supermarkets and similar vendors.”
• “Consumers who are not medical professionals can use the device safely and
effectively for its intended medical purpose with minimal or no training from a
medical professional.”
• The device is classified by the FDA under Subpart D of 21 CFR Part 890 (physical
medical devices).
Factors suggesting that a device is not exempt include the device being classified by FDA
under certain regulatory classifications, the fact that the device “must be implanted,
inserted, operated or other otherwise administered by a medical professional,” and that the
cost to acquire, maintain and/or use the device is not affordable to the average consumer.
Under the safe harbor, the following types of devices would fall within the retail exemption:
• Devices that are included in the FDA’s online IVD Home Use Lab Tests (Over-the-
Counter Tests) database
• Devices that are described as “OTC” or “over the counter” devices in the relevant
FDA classification regulation heading
• Devices that are described as “OTC” or “over the counter” devices in the FDA’s
product code name, the FDA’s device classification name, or the “classification
name” field in the FDA’s device registration and listing database
• Devices that qualify as durable medical equipment, prosthetics, orthotics, and
supplies, as described in Subpart C of 42 CFR Part 414 (Parenteral and Enteral
Nutrition) and Subpart D of 42 CFR Part 414 (Durable Medical Equipment and
Prosthetic and Orthotic Devices), for which payment is available on a purchase
basis under Medicare Part B payment rules, and are:
o “Prosthetic and orthotic devices,” as defined in 42 CFR 414.202, that do not
require implantation or insertion by a medical professional;
o “Parenteral and enteral nutrients, equipment, and supplies” as defined in 42
CFR 411.351 and described in 42 CFR 414.102(b);
o “Customized items” as described in 42 CFR 414.224;
o “Therapeutic shoes,” as described in 42 CFR 414.228(c); or
3. o Supplies necessary for the effective use of DME, as described in section
110.3 of chapter 15 of the Medicare Benefit Policy Manual (Centers for
Medicare and Medicaid Studies Publication 100-02).
The proposed regulations include examples illustrating the application of the facts and
circumstances test.
The preamble indicates that the IRS and Treasury intend through the rulemaking process
to identify easier mechanisms for applying the above exemptions. The NPRM seeks
comments on additional factors, examples, and safe harbors. It also indicates that the IRS
and Treasury are especially interested in comments on medical devices sold primarily or
exclusively through special medical retailers and on whether packaging, labeling, warranty
terms, and Internet sales are meaningful factors. The NPRM rejected a quantitative data
approach (comparing retail sales to sales to doctors’ offices and medical institutions) for
determining whether the exemption applies.
Other Device Issues
The NPRM indicates that dual use devices (ones that may be used for both medical and
nonmedical purposes) are taxable medical devices if they fall within the definition of
taxable medical devices and the retail exemption does not apply.
The NPRM also indicates that a combination product (therapeutic or diagnostic products
that combine drugs and devices) is subject to the tax if it meets the definition of a taxable
medical device and no exemption applies. The regulatory preamble states that IRS and
Treasury anticipate that few, if any, products will be subject to both the branded
prescription drug fee and medical device excise tax, but seek comments on potential
overlap and mechanisms by which the impact can be divided.
The NPRM states that devices that are subject to an FDA Investigational Device
Exemption are not taxable medical devices because they are exempt from FDA’s listing
requirements.
The NPRM rejected a blanket exclusion for dental instruments and equipment.
The proposed regulations treat a “kit” as a taxable medical device if the kit itself is listed
as a device with the FDA. If the kit is not a taxable medical device, the manufacturer of
taxable medical devices included in the kit will be liable for the tax (unless an exemption
applies) on the sale of the device to the kit manufacturer or upon the sale of the kit if the
taxable medical device manufacturer is the seller of the kit.
Manufacturers Excise Tax
The preamble to the proposed regulations indicates that statutory provisions, regulations,
rules, cases, and other published guidance applicable to manufacturers excise taxes are
applicable to the medical device excise tax. The preamble provides a useful summary of
the rules. Highlights include the following:
• If more than one person is involved in the manufacture or importation of an
item, such as in a contract manufacturing arrangement, the determination of which
person is the manufacturer is based on the facts and circumstances of the
arrangement
4. • The manufacturer’s excise tax attaches when the title to the taxable article
passes from manufacturer to purchaser. In the case of a conditional or installment
sale, the tax attaches to each partial payment
• The provision or use of a taxable medical device as a demonstration product
may constitute a taxable use or sale
• A lease is considered a sale. The tax attaches to each lease payment. If the
manufacturer sells the same product, the tax is capped when the cumulative total
of tax payments equals the total tax if the product had been sold
• The taxable sales price includes charges for coverings or containers and charges
incident to placing the article in a condition to be packed and ready for shipment,
but excludes:
o The manufacturers excise tax, whether or not it is stated as a separate
charge
o The cost of transportation, delivery, insurance, and installation
o Discounts, rebates, and similar allowances
o Charges for a warranty paid at purchaser’s option
• The tax does not apply to sales for further manufacture. To make a tax-free sale for
further manufacture of export, the manufacturer; the first purchasers; and in some
cases, the second purchaser must be registered by the IRS by filing Form 637.
Generally, the purchaser must provide the purchaser’s registration number and
certify the exempt purpose for which the article will be used.
• If taxable and nontaxable articles are sold by the manufacturer as a unit, the tax
attaches to the portion of the unit allocable to the taxable article.
Other Issues
The preamble and/or proposed regulations appear to address most, but not all, of the
issues raised in prior comments to the IRS. In particular, the regulations do not address
issues that arise because the excise tax is based on purchase price, whereas most current
manufacturers’ excise taxes are based on quantities or measures other than price. For
example, does a vertically integrated company pay the tax based on the sales price to the
final consumer while a nonvertically integrated manufacturer pays the tax based on the
sales price to the distributor? The NPRM also does not specifically address the
deductibility of the tax. Presumably, principles applicable to other manufacturers’ excise
taxes would apply.
Next Steps
Companies should consider submitting formal comments in response to the NPRM.
The preamble and proposed regulations, while not binding until adopted as final or
temporary regulations, provide sufficient guidance for manufacturers to begin work on
internal processes for implementing the tax. These may include:
• Determination as to which products are potentially taxable
• Determination of which products are eligible for the retail exemption
5. • If the manufacturer sells devices for further manufacture, taking steps to make sure
that purchasers are registered and will be providing exemption certificates
• Establishing internal procedures for recordation and reporting of taxable sales and
payment of the tax, and for the invoicing of the tax (if desired)
Patton Boggs
Patton Boggs’ team of tax, FDA, and public policy lawyers can assist clients in interpreting
and applying the excise tax rules and in seeking modifications to the NPRM.
Our team consists of:
Rosemary Becchi
202-457-5255
rbecchi@pattonboggs.com
Martha Kendrick
202-457-6520
mkendrick@pattonboggs.com
Darryl Nirenberg
202-457-6022
dnirenberg@pattonboggs.com
Paul Rubin
202-457-5646
prubin@pattonboggs.com
George Schutzer
202-457-5273
gschutzer@pattonboggs.com
For additional information, please feel free to contact us.
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