Coporate Profiles



Food, Drug, Medical Device & Cosmetic (FDA)


Spectra Law Group assists clients with the regulatory process throughout the life cycle of their products, from the early stages of planning, research and development, to product approval, marketing, post-marketing obligations and government enforcement actions.  The firm also assists in regulatory and intellectual property due diligence in business transactions and litigation matters.

In addition to its legal and regulatory experience, Spectra Law Group draws on deep background knowledge of the sciences to serve its clients.  The firm's principal attorney holds a Ph.D. in biochemistry & molecular biology and, as a FDA and patent lawyer, has worked with scientists, health care professionals and engineers in areas such as pharmacy, microbiology, neuroscience, food science, and electronics. 

The firm strives to provide sound, practical and solution-oriented services in a professional and responsive manner.  In doing business with the firm, you will soon realize that we are interested in developing relationships, not just clients.  Contact the firm to arrange a free initial consultation.




Click on an area below to learn more about the firm's services:


Foods & Dietary Supplements

Medical Devices

Pharmaceuticals & OTC Drugs

Cosmetics

Electronic & Radiological Devices

Intellectual Property & Complex Agreements




FOODS & DIETARY SUPPLEMENTS

"This statement has not been evaluated by the Food and Drug Administration."  When you see this disclaimer on the label of a dietary supplement, you might think the FDA does not regulate what you can or cannot say about foods or dietary supplements.  You are not alone.  Many companies, including large and well-established ones, have misinterpreted the disclaimer.  The FDA does regulate food products distributed in the United States.  In fact, the FDA has recently stepped up its enforcement efforts against companies for safety and labeling violations, which included issuance of warning letters, product seizures, and civil and even criminal penalties.  It's more important than ever to be sure that your products comply with applicable regulations.

Labeling Review.  FDA regulations require that certain information appear on supplement facts panelfood and dietary supplement labels, such as statement of identity, net quantity of contents, and ingredient information.  The information must also be formatted in accordance with the regulations.  By law, companies may make three types of claims on their products: health claims, structure/function claims, and nutrient content claims.  Different requirements generally apply to each type of claim. Unless specifically allowed by regulation, a company is prohibited from making labeling claims that imply its food products diagnose, cure, mitigate or prevent disease.

Spectra Law Group conducts label and ingredient reviews for all foods and dietary supplements in accordance with FDA regulations. This includes review of structure/function claim, health claims, and nutrient content claims, as well as the formatting of the labeling. The firm also can help you file a 30-Day Structure/Function Claim Notification with the FDA for your dietary supplements.


Advertising Review. Spectra Law Group provides advertising counseling for your foods and dietary supplements to ensure conformance with regards to third-party testimonials and websites, social media, claim substantiation (amount of scientific support) and various other FTC regulations.

Facility Registration and Prior Import Notice. The FDA requires facilities that manufacture, process, pack or store foods and dietary supplements marketed in the U.S. file registrations with FDA. Under the Bioterrorism Act, foreign food and dietary supplement manufacturers must also register with the FDA and provide prior notice of import before their products arrive in the U.S.  Spectra Law Group assists with filing Prior Import Notices and will work closely with your Customs broker to ensure compliance with the Bioterrorism Act and Prior Import Notice requirements.

Adverse Event Reporting & Record Keeping.  Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a dietary supplement company whose name appears on the product label must report to the FDA certain adverse events associated with the product and maintain reports of adverse events.  Spectra Law Group helps clients develop process and standard operating procedures (SOPs) for identifying and reporting adverse events, train monitoring staff on the process, and conduct audits to assess compliance.

Warning Letter & Border Detention Assistance.  If you received a warning letter from the FDA, or if your products were detained at the border, you may be able to ask the FDA to allow you to "fix" a deficiency so that you wouldn't have to destroy the products or ship them out of the country. However, you only have a short period of time to make the request, and you need to act fast.  Spectra Law Group can help you respond and take appropriate actions so you can get back to business.  Contact the firm as soon as possible for a free initial consultation.


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MEDICAL DEVICES

FDA regulates medical devices based on their intended use and risk level.  Medical devices are generally assigned to one of the three regulatory classes: Class I, Class II, and Class III.  The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance or approval to market.

Most, approximately 74%, of Class I devices do not require premarket clearance or approval from the FDA. Most of Class II and some Class I devices, on the other hand, require a 510(k) premarket notification for marketing. The submission of a 510(k) allows the FDA to determine whether the device is "substantially equivalent" to a device legally marketed in the U.S. (called a "predicate device").  A 510(k) usually requires limited or no clinical trial.

heart monitorFor Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for. In that case, a 510(k) will be the route to market. A PMA requires full reports of safety and effectiveness of the device for its intended use, and therefore generally requires clinical trials.

Device Classification.  If you intend to market a new medical device (or an existing device for a new use), it is important to figure out early on the class(es) to which your device will be assigned so that you can start planning and preparing for the type of premarketing submission/application (if any) and regulatory requirements applicable for the device. 

Sometimes a device may be assigned to multiple regulatory classes for different intended uses, and you may be able to sell the device immediately for a particular use without a 510(k). This approach can be beneficial especially for a start up company who can start generating income from a device for one intended use while preparing and applying for a 510(k) for another use.

Spectra Law Group provides clients with product development counseling, including determining possible classification(s) and regulatory requirements for your product, to help you develop a regulatory strategy that best aligns with your business goals.

Product Clearance. If a 510(k) application needs to be filed for your device, Spectra Law Group can work with you or a FDA consultant to put together the necessary application materials and file the application with FDA.  The firm can help you determine an appropriate predicate device(s) for your 510(k), and coordinate with investigators, research firms, contract manufacturers, and third parity reviewers, to conduct necessary safety and performance testing and analyses to support the 510(k) application materials. 

Labeling Review. FDA regulations require that certain information appear on medical device labels.  The information must also be formatted in accordance with the regulations.  Some devices, such as hearing aids, must also contain specified information in their instruction manuals to allow safe use of the devices.  Spectra Law Group conducts labeling review for your medical devices to ensure conformance with FDA regulations.

Advertising Review. Jurisdiction over medical device advertising is split between the FDA and the FTC. When the FDA does have jurisdiction, there are certain formal requirements that apply, and the device is misbranded if its advertising does not comply with any of the formalities. Even when the FDA does not have jurisdiction over a device's advertising, however, the agency can use that advertising as a means of showing the intended use of the device to demonstrate, for example, that the manufacturer intends the device for an unapproved use. Therefore, it is important that your websites or promotional materials do not contain any statements that would imply any unapproved use of your devices.  Spectra Law Group conducts websites and advertising review for compliance with FDA/FTC regulations.

Off-Label "Promotion". The Food and Drug Administration Modernization Act (FDAMA) describes certain conditions under which a medical device manufacturer could choose to disseminate medical and scientific information discussing unapproved uses of cleared or approved medical devices to healthcare professionals and certain entities.   FDAMA section 401 provides that, if these conditions were met, dissemination of such journal articles or reference publications would not be considered as evidence of the manufacturer's intent that the product be used for an unapproved new use.

Further, understanding the need to attract and educate potential investors, the FDA does allow the display of investigational and unapproved devices at tradeshows, in direct mailing and on websites, only under certain conditions.

Spectra Law Group provides regulatory counseling to help you develop a policy and procedures for disseminating information about your investigational or unapproved device consistent with FDA regulations, and works with you to train your marketing staff on the procedures.IVD device

Facility Registration and Product Listing. FDA requires certain facilities that  manufacture, process, pack, store or distribute medical devices marketed in the U.S. file registrations with FDA, and list their medical devices with the agency.  Spectra Law Group assist companies with facility registration and product listing requirements.


Adverse Event Reporting and Record Keeping.  Since December 13, 1984, the FDA Medical Device Reporting (MDR) regulations have required companies who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify the FDA of the incident. The Safe Medical Devices Act (SMDA) of 1990 provided the FDA with two additional postmarketing activities, Postmarket Surveillance for the monitoring of products after their clearance to market and Device Tracking for maintaining traceability of certain devices to the user level.  Spectra Law Group helps clients develop process and standard operating procedures (SOPs) for identifying and reporting adverse events, train monitoring staff on the process, and conduct audits to assess compliance with MDR regulations.


Warning Letter & Border Detention Assistance.  If you received a warning letter from the FDA, or if your products were detained at the border, you may be able to ask the FDA to allow you to "fix" a deficiency so that you wouldn't have to destroy the products or ship them out of the country. However, you only have a short period of time to make the request, and you need to act fast.  Spectra Law Group can help you respond and take appropriate actions so you can get back to business.  Contact the firm as soon as possible for a free initial consultation.


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PHARMACEUTICALS & OTC DRUGS

Drug products distributed in the U.S. must comply with the Federal Food, Drug and Cosmetic Act, no matter where they are made.  Unless exempted by law or regulation, drug products must be approved by the FDA before they can be marketed.  To obtain product approval, a firm submits to the FDA an New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) containing, among other things, research data and manufacturing information about the drug.  The ultimate goal of the NDA/ANDA is to provide enough information to permit FDA reviewer to determine that the drug is safe and effective for its intended use(s).

PillsOver-the-counter (OTC) drugs that comply with the FDA's OTC monograph regulations do not require FDA approval before they are marketed. The OTC monograph serves as a "recipe book" specifying what active ingredients may be used, at what level, and for what intended uses. These OTC drugs are classified as generally recognized as safe and effective (GRASE) for use and do not require further premarket approval by the FDA. 

Homeopathic drugs that comply with the FDA's homeopathic drug Compliance Policy Guide (CPG) also do not require FDA approval before they are marketed.  The CPG specifies conditions under which a homeopathic drug may be marketed without prior approval, and drug products that fail to meet these conditions are subject to enforcement actions. 

Labeling and Advertising Review.  Spectra Law Group provides regulatory counseling to help you determine whether your product can be marketed as an OTC drug under the OTC monograph, a homeopathic drug, or require an New Drug Application.  The firm also assists client with labeling and advertising review to help ensure compliance with applicable federal regulations.

Facility Registration and Product Listing.  All drug manufacturers, processors, packers, repackers, labelers, and relabelers who offer drugs for sale or distribution in the U.S. are required to register their drug establishments with the FDA.  Every drug establishment registered with FDA must submit a list of every drug they have in commercial distribution to obtain NDC (National Drug Code) numbers.  Spectra Law Group can help register your drug establishment, list your drug products, and can act as the U.S. Agent for foreign drug manufacturers.

Adverse Event Reporting & Record Keeping.  Drug firms are required to report to the FDA certain adverse events associated with their products and maintain reports of adverse events.  Spectra Law Group helps clients develop process and standard operating procedures (SOPs) for identifying and reporting adverse events, train monitoring staff on the process, and conduct audits to assess compliance

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COSMETICS 

Cosmetics marketed in the U.S. must comply with the Federal Food, Drug and Cosmetic Act, Fair Packaging and Labeling Act and other federal regulations.  With the exceptions of certain color additives, cosmetics and their ingredients do not require cosmeticsFDA approval for marketing. 

Federal law defines cosmetics by their intended use, as  "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance." 

Most firms run into trouble when their product labeling makes drug or disease claims.  Examples include claims that their products will restore hair growth, reduce cellulite, or remove wrinkle. The differences between a cosmetic claim and a drug claim can be subtle, and failure to appreciate the subtleties can result in enforcement actions by the FDA.  Spectra Law Group conducts ingredient and labeling review of your cosmetics as well as an analysis of any claims made on your website to help ensure compliance with FDA regulations.  

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ELECTRONIC & RADIOLOGICAL DEVICES

The FDA regulates radiation emitting electronic products even when they are not intended to be used for medical purposes.  X-rays, microwaves, radio waves, laser, visible light, sound, ultrasound, and ultraviolet light are a few examples of the many types of radiation that may be produced by an electronic product.  Diagnostic X-ray systems, laser products, laser light shows, and microwave ovens are a few examples out of the many different electronic products that emit radiation subject to FDA regulation.

Many radiation emitting electronic products are also medical devices.  In those cases, the products must comply with two independent sets of regulations - radiation safety regulations that apply to radiation emitting electronic products, as well as medical device regulations that apply to all (including non-electronic) medical devices.

Electronic Product Reports / Accession Numbers. The radiation safety regulations specify electronic product performance standards covering several varieties of radiation emitting electronic products. Companies that manufacture or import electronic products subject to an FDA performance standard are required to submit various electronic product reports to the FDA to demonstrate that their products comply with the standard.  The most important and basic of the reports is the Electronic Product Initial Report.

When a manufacturer or importer submits an Electronic Product Initial Report to the FDA, the FDA reviews the report to ensure compliance with any applicable manufacturing and performance standards.  The FDA then issues Accession Numbers to the manufacturer. The FDA and U.S. Customs require declaration of Accession Numbers on import forms when importing electronic products into the U.S.


Unless exempted by the radiation safety regulations, a manufacturer or importer must also submit to the FDA follow-up reports for product updates or modifications, as well as an annual report for their radiation emitting electronic products.


Spectra Law Group helps clients identify and implement applicable performance standards and other regulatory requirements for their electronic products, and assists with the preparation and submission of electronic product reports for obtaining Accession Numbers.


Label Review The radiation safety regulations provide specific certification and labeling requirements for electronic products.  Labeling, which includes user manuals, must contain certain information, such as warnings, declarations and clear and concise instructions for use and service.  The information must also be formatted in accordance with the regulations.  Spectra Law Group conducts label reviews for electronic products in accordance with FDA regulations.


Warning Letter & Border Detention Assistance.  If you received a warning letter from the FDA, or if your electronic products were detained at the border, you may be able to ask the FDA to allow you to "fix" a deficiency (implement a corrective actions plan) so that you wouldn't have to destroy the products or ship them out of the country.  This may require you to repurchase, repair or replace the products already delivered to your customers.  However, you only have a short period of time to make the request, and you need to act fast.  Spectra Law Group can help you respond and take appropriate actions so you can get back to business.  Contact the firm as soon as possible for a free initial consultation.



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INTELLECTUAL PROPERTY & COMPLEX AGREEMENTS

Spectra Law Groups counsels and represents FDA-regulated industry in complex business and corporate transactions involving intellectual property (IP).  The firm helps clients structure and negotiate licensing arrangements, research and development contracts, manufacturing agreements, sales and distribution arrangements, and a variety of other issues faced by the industry.

The Firm also counsels and assists clients in procuring and obtaining patent and trademark protection through the application process.

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