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

FDA's Agenda for 2011

Hello!!

I hope that the first 2 months of 2011 are going well for you and your business.  The information below was published in the Federal Register on December 20, 2010 but being that it is FDA’s published regulatory agenda, it is pertinent to any company regulated by FDA and provides a look at changes to anticipate. 

The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require that government agencies publish an inventory of rulemaking actions under development semi-annually so that we, the public, may be aware of and comment on the actions proposed on our behalf. (Not sure whether to grin or grimace here but that’s the story.)

There is something for everyone here.  FDA has been working since the 1960’s to update the monographs that regulate over the counter drugs—many of those remain on the agenda for 2011. In 2010 the agency proposed drastic changes to the process for medical device approvals and more ideas are noted on the agenda below.  Other highlights include upcoming rules on food labeling, infant formula GMPs, pet food labeling, and the use of cattle-derived ingredients in cosmetics as well as proposed rules affecting prescription drugs and biologics. New areas of FDA regulation—restaurant menus and tobacco products also made the agency’s ‘to do’ list.  The dietary supplement sector only makes the list for long term actions.

I have rearranged the agenda into product areas for your convenience.  To view the list as originally published visit http://www.gpo.gov/fdsys/ and search the Federal Register, Vol. 75, No. 243, December 20, 2010, p.79765-75767. The numbers preceding each listing are the sequence number and can be used to find more information about each rule when you visit the Federal Register. 

I would be happy to address questions you submit about these topics in future updates.  You may read past updates here on our blog, Bioscience FDA Update (http://biotransapp.blogspot.com/) . You are also invited to leave comments.

 

Food Pre-Rule Stage

311 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution

Food Proposed Rule Stage

328 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines 

329 Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants

Food Final Rule Stage

338 Use of Materials Derived From Cattle in Human Food and Cosmetics

339 Label Requirement for Food That Has Been Refused Admission Into the United States

Food Long Term Actions

355 Produce Safety Regulation .

356 Modernization of the Current Food Good Manufacturing Practices Regulation

Infant Formula Final Rule Stage

333 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements;

Records and Reports; and Quality Factors 

Dietary Supplement Long Term Actions

340 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements

Pet Food and Animal Feed Proposed Rule Stage

318 Import Tolerances for Residues of Unapproved New Animal Drugs in Food

320 Pet Food Labeling Requirements

321 Process Controls for Animal Feed Ingredients and Mixed Animal Feed

Cosmetic Final Rule Stage

338 Use of Materials Derived From Cattle in Human Food and Cosmetics

Over the Counter Drug Proposed Rule Stage

313 Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products

314 Over-the-Counter (OTC) Drug Review—Internal Analgesic Products

315 Over-the-Counter (OTC) Drug Review—Laxative Drug Products

316 Over-the-Counter (OTC) Drug Review—Sunscreen Products

317 Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products

322 Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products

Over the Counter Drug Final Rule Stage

334 Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products

335 Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products

336 Over-the-Counter (OTC) Drug Review—External Analgesic Products

337 Over-the-Counter (OTC) Drug Review—Skin Protectant Products

Over the Counter Drug Long Term Action

341 Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products

342 Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use

343 Over-the-Counter (OTC) Drug Review—Ophthalmic Products

344 Over-the-Counter (OTC) Drug Review—Oral Health Care Products

345 Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products

346 Over-the-Counter (OTC) Drug Review—Weight Control Product

347 Over-the-Counter (OTC) Drug Review—Overindulgence in Food and Drink Products

348 Over-the-Counter (OTC) Drug Review—Antacid Products

349 Over-the-Counter (OTC) Drug Review—Skin Bleaching Products

350 Over-the-Counter (OTC) Drug Review—Stimulant Drug Products

351 Over-the-Counter (OTC) Drug Review—Antidiarrheal Drug Products

352 Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products

353 Over-the-Counter (OTC) Drug Review—Certain Category II Active Ingredients

Medical Device Proposed Rule Stage

319 Laser Products; Amendment to Performance Standard

324 Unique Device Identification

327 General Hospital and Personal Use Devices: Designation of Special Controls for Infusion Pumps

Medical Device Final Rule Stage

331 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements

Tobacco Product Proposed Rule Stage

325 Cigars Subject to the Family Smoking Prevention and Tobacco Control Act

326 Cigarette Warning Label Statements

Prescription Drug & Biologics Proposed Rule Stage

312 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 

323 Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products

Prescription Drug & Biologics Final Rule Stage

330 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products

332 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and

Lactation Labeling

Prescription Drug & Biologics Long-Term Actions

354 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and

Administrative Procedures.

New FDA Update Blog

Hello!

For several years I have been sending occasional email updates on various FDA and sometimes USDA topics to clients of Bioscience Translation & Application (www.BioTransApp.com), a service of Cadman Consulting Services, LLC.  I frequently hear back that the information is helpful and I have decided to collect those messages in a blog.  I will also use this blog to comment on other regulatory issues that perhaps don't warrant an email.

I will be working to establish different pages for different regulatory sectors: Food, Dietary Supplements, Cosmetics, Medical Devices, Drugs, etc. so that you can easily find topics of interest.

I hope that you will find the information helpful and interesting!

Evelyn

FDA and FCC to work Jointly on the Development of Wireless Medical Devices

Hello!

Last week the Food and Drug Administration and the Federal Communications Commission issued a joint statement regarding their intent to proactively address issues that arise when medical devices send patient information to physicians wirelessly.  Issues such as the reliability and privacy of the communication are of particular concern.  If the communication link is not reliable it could affect patient care and health outcomes if vital data is either incomplete or simply not received by the physician.  It is also vitally important to ensure that patient data cannot be obtained by eavesdropping or overt hacking.

You may read the agencies’ statement at: http://www.fda.gov/MedicalDevices/NewsEvents/ucm220277.htm

Bioscience Translation & Application has expert associates ready to serve you in the area of medical device regulation and we welcome your questions regarding these products.Visit us at www.BioTransApp.com.