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Thursday, November 17, 2011

Change of effective date: Nutrition Labeling of Major Cuts of Meat Required by March 2012

Just a quick note: On September 14th we posted about USDA's requirement for listing nutritional information for major cuts of meat in retail establishments. At that time the effective date was January 1, 2012 but last week USDA announced that they have push the effective date back to March 1, 2012

Saturday, November 12, 2011

Labels as Tables of Contents

Greetings!

Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc (http://www.nosco.com/), presented information on packaging, labeling and compliance.  I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that can guide an inspection of your manufacturing facility.  For instance, the net contents statement clues an inspector in on the type of equipment they will be reviewing: liquid or powder fill, tableting or encapsulation.  Whether the product is a food, drug, cosmetic or dietary supplement, the statement of identity, along with product claims, determines which regulations apply.  Claims used on the product label also convey the amount and type of data that should be on file to support the claims so that you can comply with the requirement that all claims be truthful, not misleading and supported by data.

If the product is a dietary supplement, the supplement facts box outlines the manufacturing process.  If the facts box lists a proprietary blend, then the standard operating procedure or SOP should reflect a blending step.  The supplement facts box can provide a list of herbs that may require identity testing or that may need to be the subject of a new dietary ingredient notification. Nutrition Facts boxes on foods or Drug Facts boxes on over the counter drug products guide inspectors to look for data to support the values declared or to demonstrate adherence to applicable monographs.The ingredient list is another place when an inspector may look for ingredients that may not be permitted in products marketed in the United States.

Finally, the signature line listing the name and place of business of the company introducing the product into the marketplace, assigns responsibility for compliance with labeling regulations, good manufacturing practices and adverse event reporting system. In the event an inspector finds something amiss, the signature line names the company that will get the 483 or possible warning letter.

With so much riding on the information listed on your product label, don’t ignore the importance of ensuring that your labeling is correct and complies with FDA regulations.   Visit our websites, www.BioTransApp.com or www.FDAlabels.com for more information on labeling or other FDA compliance issues.  This blog discusses issues pertinent to FDA-regulated industries. Post a comment to let us know if you would like to subscribe to occasional email updates targeted to your industry sector.


Copyright 2011 Bioscience Translation & Application

Wednesday, September 14, 2011

Nutrition Labeling of Major Cuts of Meat Required by January 2012

Hello!

I know the name of this blog is FDA Update but my team provides USDA regulatory help from time to time and that agency has caught my attention today.    My favorite blog, FDA Law Blog by Hyman Phelps & McNamara posted about the new USDA requirement for nutrition labeling on major cuts of meat here: FDA Law Blog USDA Nutrition Labeling.  It got me wondering what my local, independent butcher was doing to comply, so I called him and initially ruined his day.  I felt so bad!  I ended up researching the rule more thoroughly and found that USDA's Food Safety and Information Service (FSIS) has prepared posters that butcher and other meat retailers can print and display to comply with the labeling rule. I called my butcher back and told him the good news sent him the posters.  So, here for your convenience are links to the FSIS nutrition labeling posters: Beef & Veal, Chicken & Turkey and Pork & Lamb.  The posters are high resolution PDFs that can be enlarged as needed.  I suggest that butchers and other small business meat retailers go to their local print shop and get large laminated versions that can be displayed in the shop.  

There are other requirements for posting nutrition information for ground products.  Many small business owners are exempt but consumers may seek the information. For a list of other information on this new rule visit the this page at the FSIS website. 


You can also visit the Bioscience Translation & Application  website atwww.BioTransApp.com.

Thursday, July 28, 2011

FDA on Sunscreens


In January we told you about some of FDA’s plans for 2011 (http://biotransapp.blogspot.com/2011_02_01_archive.html). The agenda listed 18 types of over the counter drug products that are the subject of proposed rulemaking or other agency review.  Back in June FDA completed one agenda item, review of proposed rules for sunscreen products, by publishing four documents:  a guidance document, a proposed rule, an announcement of proposed rulemaking and one final rule. This product sector has been subject to changing unclear regulation since 1978 when FDA first announced its intention to regulate sunscreen products as drugs rather than as cosmetics. Since that time much has been learned about both the effect of sun on the skin and how various sunscreens work.  This has led to a new labeling term for sunscreens: broad spectrum. To use this term sunscreen manufacturers will have to demonstrate through testing that their product reduces the effect of both UVB rays that cause sunburn and UVA rays that affect skin aging and contribute to development of skin cancer.    More information on this claim and the testing required to meet the claim can be found in the final rule: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14766.pdf .  This rule becomes effective June 18, 2012 and in addition to allowing the ‘broad spectrum’ claim, it also prohibits the use of the terms ‘waterproof’, ’sweatproof’ or ‘sunblock’..

In addition to this final rule FDA issued an advance notice of proposed rulemaking that seeks information on the safety and effectiveness of spray on sunscreens http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14768.pdf.  The agency also proposed limiting SPF claims to 50+ since there is insufficient data that an SPF greater than 50 actually provides greater benefit http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14769.pdf.

Because sunscreen regulations have been in flux for the past 23 years, FDA also issued a guidance document to provide industry information on the types of sunscreen products that may be marketed without risk of FDA enforcement action.  Many sunscreens currently on the market contain ingredients that FDA has not reviewed or approved.  The agency has not taken enforcement action against such products since there were no clear regulations to follow.  Now FDA is stating that products that contain ingredients that were listed in the (still) tentative final monograph published in 1999 (see list at the end of this message) and which have been tested for effectiveness using methods included in FDA rules published in 2011, 2007 or 1999 may be marketed without enforcement actions if they comply with the new rules on claims.

It will be interesting to see which of the other 17 OTC categories FDA tackles next.  Whether it is cough and cold medications, weight control, antacid, antimicrobial or skin protectant products, the OTC team at Bioscience Translation & Application will be working to remain up to date in order to provide our clients with top-notch regulatory support.  Contact us with your question regarding how your product is regulated by FDA.

Sincerely,
Evelyn Cadman and Associates

The following active ingredients were listed in the 1999 Tentative Final Monograph, with GRASE maximum concentrations as shown:
·       Aminobenzoic acid (PABA), 15 percent
·       Avobenzone, 3 percent
·       Cinoxate, 3 percent
·       Dioxybenzone, 3 percent
·       Ensulizole, 4 percent
·       Homosalate, 15 percent
·       Octinoxate, 7.5 percent
·       Octisalate, 5 percent
·       Octocrylene, 10 percent
·       Oxybenzone, 6 percent
·       Padimate O, 8 percent
·       Sulisobenzone, 10 percent
·       Titanium dioxide, 25 percent
·       Trolamine salicylate, 12 percent
·       Zinc Oxide, 24 percent
These ingredients may be used at these concentrations in combinations as long as each active ingredient contributes a minimum SPF of 2 to the finished product, except that avobenzone may not be combined with aminobenzoic acid (PABA), menthyl anthranilate padimate O, titanium dioxide, and zinc oxide.

Wednesday, July 13, 2011

Press Release:

 
Press Release

Evelyn Cadman
Bioscience Translation & Application
a service of Cadman Consulting Services, LLC

Zachary Brousseau
Senior Manager, Communications, RAPS
+1 301 770 2920, ext. 245; zbrousseau@raps.org
FOR IMMEDIATE RELEASE
July 13, 2011
Evelyn Cadman of Bioscience Translation & Application, Contributes to New Edition of RAPS’ Essential Regulatory Affairs Text Book

Fundamentals of US Regulatory Affairs, Seventh Edition now available

Rockville, MD, USA—The Regulatory Affairs Professionals Society (RAPS) has published a new edition of its popular text, Fundamentals of US Regulatory Affairs, regarded by many as the essential reference guide to regulatory affairs for healthcare products marketed in the US. Among the book’s authors is Evelyn Cadman of Bioscience Translation & Application.  Fundamentals of US Regulatory Affairs, Seventh Edition covers US regulatory requirements across healthcare product lines, including pharmaceuticals, medical devices, biologics and other product classifications. Ms. Cadman wrote the chapter on cosmetic regulations, co-authored the chapter on Dietary Supplements and Homeopathic Products and edited and updated the chapter on Food Products.

The seventh edition of US Fundamentals has been updated to address current regulatory requirements from the US Food and Drug Administration (FDA) and other state and federal agencies, throughout the product lifecycle. New in this edition are chapters on Drug, Biologic and Device Regulatory Pathways; FDA Communications and Meetings; Patents and Exclusivity; and Veterinary Products.

“Advances in medical science and technology are happening faster than ever. Regulations and official guidances from FDA and other agencies overseeing the drugs, medical devices and other healthcare products we use every day are also evolving rapidly,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “It is absolutely critical for regulatory professionals of all experience levels to have the most current information available, and Fundamentals of US Regulatory Affairs is an indispensible tool for both learning and reference.”

The book is well-suited to professionals new to US regulatory affairs, those preparing for the US Regulatory Affairs Certification (RAC) exam or those looking for a refresher or reference on US regulatory requirements, processes and concepts. It is used as an important training tool at many prominent healthcare organizations and is a mandatory text for many university-level courses.

Fundamentals of US Regulatory Affairs, Seventh Edition is available for purchase online from the RAPS Store for $239.95 with free shipping for RAPS members or $299.95, plus shipping, for nonmembers. It can also be purchased as part of an RAC (US) exam prep package. An updated e-book version will be available soon.

About RAPS
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org

###
Making better healthcare products possiblesm

5635 Fishers Lane, Suite 550 Rockville, MD 20852 Phone: +1 301 770 2920 
 Fax: +1 301 770 2924 www.raps.org

Tuesday, July 5, 2011

FDA Draft Guidance on New Dietary Ingredient Notifications

Hello!

Summer is in full swing here in the Northern Hemisphere and FDA is heating things up for the US dietary supplement industry.  On Friday, July 1, 2011 FDA published the long-anticipated Draft Guidance for Industry on Dietary Supplement New Dietary Ingredient Notifications. You can read the whole guidance at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm.  The issuance of this guidance was mandated by the Food Safety Modernization Act signed into law in January of this year. The goal is to clarify when a New Dietary Ingredient Notification should be submitted.  New Dietary Ingredients are substances intended for use in dietary supplement products which both meet the definition of ‘dietary ingredient’ and which were not marketed as dietary ingredients prior to October 15, 1994, the day that the Dietary Supplement Health Education Act became law.

Our team routinely checks ingredients in dietary supplement products we review for their regulatory status and we also work on New Dietary Ingredient Notifications. As the lead consultant for our group, I work hard at keeping up with FDA guidance documents and warning letters. Nevertheless, I was surprised and even shocked by some of the things I found in the guidance upon first reading today and thought you might be interested in them also.

Dietary supplements are regulated as a special class of foods in the US and prior to issuance of this guidance, my team and I understood that conventional food ingredients that met the definition of dietary ingredients and that were not chemically altered were not new dietary ingredients and would not require a notification (NDIN).  According to the guidance, there are circumstances in which an NDIN would not be required BUT the product could be considered adulterated under certain circumstances if no NDIN has been filed.  Frankly, I need to read these sections a few more times and probably draw a diagram to figure these details out because the various exceptions are confusing. 

It has been common practice for dietary supplement manufacturers to rely on NDINs made by other companies, trusting that once an NDIN had been filed and FDA had no objections, anyone could market the ingredient. However, the NDIN draft guidance makes it clear that EVERY manufacturer must submit an NDIN if they plan to market a dietary ingredient that was not marketed prior to October 15, 1994.  This interpretation, once enforced, could readily result in branding two thirds of the dietary supplements currently on the market as adulterated. Clearly, companies and consultants will be very busy filing NDINs for ingredients and products that have been sold for years.

This next issue that got my attention was not really surprising, since FDA has been applying this standard to recent NDINs, but still breathtaking to see spelled out: The draft guidance unequivocally states that synthetic versions of naturally occurring substances ARE NOT dietary ingredients unless they were marketed as dietary supplements prior to October 15, 1994.  Most vitamins are safe since synthetic versions were used prior to that date but what about indol-3-carbinol, limonene, resveratrol, various isoflavones and countless other phytochemicals that are valuable for maintaining health but occur in amounts too small to make extraction with water and ethanol feasible and affordable. (Note that water and ethanol were the only solvents the guidance listed as not chemically modifying an ingredient.)  Seems that ingredient manufacturers need to hustle and see if they have sufficient data to obtain GRAS status for use of their ingredients in dietary supplements. 

Similarly, naturally-occurring metabolites and other biochemicals that have been stabilized by adding esters or other chemical moieties are not considered dietary ingredients.  It is clear from the guidance document that FDA has reviewed some supplements that are on the market and determined that they have been “chemically altered” and do not meet the criteria to be sold as dietary ingredients. One example of this is high selenium yeast.  The guidance states that chemical alteration includes, “Changing agricultural or fermentation conditions to alter the chemical composition of the ingredient, such as by sprouting garlic or fermenting yeast using a medium containing large amounts of sodium selenite to create large amounts of organic selenium compounds.” It also appears that FDA would consider some probiotics as chemically altered by “use of a defined commercial growth medium to produce a microorganism previously made by fermenting milk into dairy products like yogurt or cheese.”

The draft guidance on New Dietary Ingredient Notifications will undoubtedly have a tremendous impact on the US dietary supplement industry. We will continue to review the guidance and provide you with insights in the coming weeks.  In the meantime, contact us with questions regarding New Dietary Ingredient Notifications (NDINs); Generally Regarded As Safe (GRAS) designation or your other regulatory affairs needs.

To subscribe to our newsletter, reply to this post!

Sincerely,
Evelyn and Team
Bioscience Translation & Application

Tuesday, June 21, 2011

Does your Contract Manufacturer Comply with cGMPS?


Hello!

I hope that your business is doing well enough to allow you to relax a bit as summer starts.  Knowing that your contract manufacturer complies with FDA’s current Good Manufacturing Practices (cGMPs) can reduce stress a bit. But how do you know that their cGMPs are up to snuff?  Many of you will recall conversations we’ve had about ingredient specifications and certificates of analysis. Well, today I saw a well-written article on this topic in Natural Products Insider by Kevin Cloud, senior method development chemist in the Capsugel Licaps® laboratory.  You may read the article below or link to it here: http://www.naturalproductsinsider.com/articles/2011/06/inquire-about-incoming-ingredient-inspection.aspx

FDA continues to inspect dietary supplement manufacturers and to write warning letters detailing a wide variety of GMP violations. Responding to such letters and correcting the violations can mean that your manufacturer may not be able to fulfill your next order on time or worse, that your product will have to be recalled and possibly destroyed if not produced under cGMPs.  Something like that would certainly ruin your summer.

Avoid future problems by thoroughly investigating your manufacturer and suppliers and be aware of the GMPs that you as the distributor must have in place.  The team at Bioscience Translation & Application wants to help you succeed.  Contact us for help with labels, GMPs or your questions about FDA regulations and processes.

Happy Summer!
Evelyn & Associates
Bioscience Translation & Application

Inquire About Incoming Ingredient Inspection
By Kevin Cloud
Natural Products Insider
June 17, 2011
 Dietary supplement cGMPs (current good manufacturing practices) establish minimum practices necessary for activities related to manufacturing, packaging, labeling and holding dietary supplements to ensure product quality. The final product owner is ultimately responsible for the dietary supplement that is released to the market, and each company in the supply chain contracted by the final product owner is responsible for ensuring its activities comply with cGMPs. Final product owners should make sure contract manufacturers have the resources, processes and commitment to comply with the cGMPs.
One important part of the equation for manufacturers is to ensure the integrity and quality of the raw materials purchased for production of finished goods. Federal regulations require manufacturers establish raw material specifications covering identity, purity, strength, composition and limits on contamination before placing an order.
How can the final product owner ensure these specifications are met? By asking three simple questions related to ingredient identification, and getting the answers related to testing, equipment and results in writing.
Question 1: Can I see the raw material specifications for raw material X that will be included in my product?
The contract manufacturer should provide a copy of a specification with all of the testing that is expected to be performed plus the criteria for passing or failing the raw material. Following are examples of mandatory specification parameters and what information they provide:
  • Identity: What is the substance? Is it the ingredient as desired, to ensure the integrity of the product as labeled? Or is it a mixture or even perhaps an entirely different substance altogether?
  • Assay: Determines the strength or potency of a substance.
Contamination: Determines unwanted substances in the raw material, such as heavy metals, pesticides and residual solvents, and any allowable limits.
Question 2: What instruments does your facility use to identify the incoming raw material X and can I see the qualification package for at least one of these instruments?
The manufacturer should have the ability to provide copies of the qualifications for each instrument listed. A qualification is made up of three distinct parts: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The qualification package is usually purchased at the time the instrument is installed or moved. The qualification is performed by a certified technician from the manufacturer of the equipment.
Typical laboratory instruments used for testing include high performance liquid chromatography (HPLC); gas chromatography (GC); ultraviolet visible spectroscopy (UV/Vis); fourier transform infrared spectroscopy (FTIR); high performance thin layer chromatography (HPTLC); melting point (MP); microscope; and near infrared spectroscopy (NearIR).
Question 3: What types of methods are you using to assay incoming raw material X and can I see a validation/verification summary and standard operating procedure (SOP) for that raw material?
From the list of instruments above, HPLC is the workhorse of the nutrition industry for analyzing potency or strength of a substance. But HPLC is only a piece of equipment. A method, or set of directions, is also essential to assay a sample; it is like a road map for the HPLC.
Whatever method or direction is used—and there are many from a wide variety of sources—it should be scientifically valid. Some recognized scientific compilations of methods are the U.S. Pharmacopeia (USP), American Oil Chemist Society (AOCS), Japanese Pharmacopeia (JP) and British Pharmacopeia (BP). Methods are often put into a company’s particular format, such as a SOP, a standard operating instruction (SOI) or a work instruction (WI).
Remember the final product owner is ultimately responsible for the dietary supplement released to the market, and that responsibility includes ensuring the product is manufactured, packaged, labeled and held according to dietary supplement cGMPs. Asking some basic questions related to ingredient qualification can provide helpful information, realizing a manufacturer that is missing any of the three major components—raw material specs, qualified instruments or written procedures—is not compliant with cGMPs.


Evelyn Cadman
Principal Consultant

Monday, April 25, 2011

Hand Sanitizers and OTC Drug Regulation

In August of last year we sent our cosmetic and OTC drug clients a link to a Hyman, Phelps and McNamara Law Blog Post about a lawsuit against FDA that sought to force the agency to finalize the tentative final monograph on hand sanitizers that has been “tentative” since 1994. This week FDA issued four warning letters to companies promoting hand sanitizers and other products as effective again MRSA (methicillin-resistant Staphylococcus aureus bacteria).  FDA issued a press announcement about these letters due to the concern that the public could be misled and subsequently harmed by the MRSA claims (http://tinyurl.com/4x6j777).  I find the warning letters interesting because of what we can learn about the regulation of over the counter drug products, particularly those under review by FDA or subject to tentative final monographs.

One of these warning letters went to Oh So Clean, Inc, doing business as CleanWell Company, which markets thymol-based hand sanitizers and sanitizing wipes. (Thymol is a constituent in the herb thyme.)  The warning letter demonstrates how FDA can enforce the stipulations of over the counter drug monographs that remain tentative. The warning letter results from FDA inspection of the company in August of 2010.  At that time CleanWell Company received a 483 letter detailing the violations FDA observed during the inspection. The warning letter issued last week notes that the company’s September response to the 483 letter “lacks sufficient corrective actions” and details FDA’s findings that the products are unapproved new drugs.

Based on the product labels and the company’s website, FDA categorizes the CleanWell products as “OTC topical antimicrobials” and cites the tentative final monographs (TFMs) for OTC healthcare antiseptics and OTC first aid antiseptics as the governing regulations for these products.  Interestingly, the response to an inquiry our company made to FDA in 2009 listed only the healthcare TFM as pertaining to hand sanitizers. Nevertheless, both of these monographs are being evaluated under FDA's OTC Drug Review process and the April 18 warning letter notes that “Pending a final monograph, the agency does not object to the marketing of OTC drugs that meet the formulation and labeling requirements described in the TFM.”  Unfortunately, the CleanWell “products’ formulation and labeling are not consistent with any of these TFMs.”  You can review the TFMs at http://tinyurl.com/3pxx464.

So what were the problems with these products?

First, the drug facts boxes identified Thymus vulgaris oil (thymol 0.05%) as the only active ingredient. The pertinent TFMs do not list this as an approved active ingredient but the First Aid Antiseptic TFM lists thymol in combination with eucalyptus, menthol, methyl salicylate and alcohol as an acceptable active ingredient. In addition, the product claims go beyond what is permitted by the tentative final monographs for antiseptic products. In particular, the claims of effectiveness against MRSA are non-monograph. The only way to make claims outside of those detailed in the monographs is to undertake clinical trials in order to gain FDA approval for new over the counter drug claims.

Even if thymol alone were an acceptable active ingredient for this type of OTC product, the company’s own website and other labeling state that active ingredient used in the products is a blend of essential plant oils.  FDA refers to incorrect labeling such as this as “misbranding”.

The warning letter further cites violations of good manufacturing practices, which render the products “adulterated” and orders the company to “cease manufacturing and distributing all your unapproved new drug products” and to take corrective action and respond to the warning letter within 15 working days. This is undoubtedly a real blow to products that were available in several well-known retail outlets.  

Similar problems were noted in the other warning letters about MRSA claims—simple failure to follow the monographs, which detail how to formulate and label over the counter drug products.  It is our view that timely and competent review of the product labels and claims could have helped these companies identify the issues cited by FDA and remain active in the marketplace.  Is your product compliant with applicable FDA regulations or has a slight tweak of the marketing materials skewed your claims beyond those permitted?  Let the Bioscience Translation & Application team help you ensure compliance so your marketing plans are not disrupted by FDA enforcement activities.

We invite you to subscribe to our RSS news feed or to become part of our mailing list: http://www.biotransapp.com/contact.htm.

Thursday, April 14, 2011

Medical Device Import Entry Review Process


Hello!

The device industry in the US continues to wonder what will become of the 510(k) process.  Senator John Kerry of Massachusetts has written a letter to FDA Commissioner Dr. Margaret Hamburg raising concerns that the medical device industry has over potential changes to the 510(k) process.  You can read more about his letter here: http://tinurl.com/3wyoqsw

FDA raised more concerns and sowed seeds of confusion in the medical device industry by publishing a letter about the import entry review process. (see http://tinyurl.com/4rqlg3r)  I too was confused and so contacted the Center for Device and Radiologic Health (CDRH) for clarification.  Turns out there is nothing new about the process and all that CDRH wanted to say is that imported devices can clear FDA’s border inspections faster if the paperwork includes the A of C code for the medical device being imported.

When importing a medical device into the US, the accompanying entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. When importing devices you must provide the following information:
  1. Foreign manufacturer number (obtained from FDA when the manufacturer registers with FDA)
  2. Listing information (Listing of the devices the company manufactures—this is done in conjunction with the registration process.)
  3. Identity of the initial importer
  4. The 510(k) or PMA number for the device

All of this information is communicated by the A of C codes and FDA’s March letter was simply trying to convey that the AofC codes are very helpful to the agency—so what is an AofC code?

AofC stands for ‘Affirmation of Compliance’.  Use of the code conveys the information listed in 1-4 above but goes further—the importer is pledging, affirming, swearing, that the product meets all FDA requirements specific to each code. So the good news is that you may be able to expedite entry of your devices into the US.  The bad news is that there are some devices that do not have AofC codes.  The codes can be found at the end of FDA’s letter.

My associates and I hope that your product is successful whether you are importing your device or manufacturing it in the US.  Contact us with your regulatory needs be it registration, listing or 510(k) or PMA submissions.

Learn more about the services we offer at www.BioTransApp.com.

Regards,
Evelyn