April 10, 2014

FDA Draft Medical Device Development Tools Guidance is Here to Help

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

A new FDA draft guidance just issued by the Center for Devices and Diagnostic Health (CDRH), outlining a voluntary process for qualification of medical device development tools (MDDT), is designed to facilitate the development and “timely evaluation of innovative” medical devices, the Center says.

An MDDT is a scientifically validated tool — such as a clinical outcome assessment or a test to detect or measure a biomarker — designed to aid device development and regulatory evaluation.

The guidance, issued November 14, 2013, describes the framework and process of voluntary CDRH qualification of MDDT.

It also includes a helpful definition of key concepts that provide something of a window into FDA’s viewpoint and regulatory expectations. Here are two important examples of how FDA views the world:

  • Qualification: A conclusion that within a specified context of use (FDA’s italics), CDRH expects that the results of an assessment that uses MDDT can be relied upon to support device development and regulatory-decision making.
  • Context of Use: Use defined in part by the device or product area for which the MDDT is qualified, the stage of device development, and the specific role of the MDDT.

FDAlogoCDRH is developing a qualification process because it provides a mechanism for leveraging advances in regulatory science, encouraging MDDT development and adoption, and “facilitating faster, more efficient device development and regulatory evaluation,” the draft guidance states.

However, the guidance intentionally stays away from any specific evidentiary or performance expectations the agency would have for qualifying a specific MDDT.

FDA is accepting comment and suggestions for revising the guidance until early February 2014. Electronic comments should be sent to http://www.regulations.gov.

 

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FDA: Get Ready, the World is Getting Ready to Change

Jeff Mazik, Vice President, Life Science Solutions, AssurX

Jeff Mazik, Vice President, Life Science Solutions, AssurX

This headline statement was shared by Michael Fauntleroy, FDA’s ESG Program Manager, during last week’s RAPS 2013 conference. It was in relation to his opinion that all FDA submissions in the future will require to be electronic. Mr. Fauntleroy also states that all adverse events for medical devices will require submitters to use the agency’s ESG (Electronic Submissions Gateway) by 2015. Furthermore, he expects that all adverse events for individualized commercial products submissions to be mandated by 2017.

However, the industry is already utilizing the technology as Mr. Fauntleroy noted: already this year the ESG has received over 4.5 million transactions in total, with over 1.1 million to the CDRH.

It is obvious that the ESG is FDA’s “go to” technology for its connection to the world when it comes to incoming submissions, their acknowledgements, and routing for processing. We have seen this focus on the ESG in numerous other ways recently. As announced by the FDA two weeks ago, the UDI (Unique Device Identifier) database termed “GUDID” will be populated via submissions that are handled through the ESG. Furthermore, as reported last week by Mr. Fauntleroy, a partnership between FDA and Canada Health utilizes the ESG to help standardize the submission process for both countries, and routes submissions accordingly. This allows medical device companies to send their submissions to one location (with the same set of requirements, and typically no additional programming for the submitter) and the submissions route to the desired country’s health organization for acknowledgement and processing.

 

eMDR

AssurX eMDR Process

AssurX worked in close coordination with the FDA over the years as we developed our AssurX eMDR solution that utilizes the FDA’s ESG for electronic submissions. In fact, Mr. Fauntleroy noted how prevalent AssurX customers are in utilizing this technology as he continues to see more and more AssurX accounts requesting access and others actively utilizing the ESG with their eMDR submissions. We are truly happy that the solution we have provided to our customers has been used and accepted so favorably by the industry. We look forward to the continued use of our software with the ESG technology for other regulatory submission needs in the future.

Click here for more information in AssurX’s turnkey eMDR solution which communicates directly with FDA’s Electronic Submissions Gateway

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FDA Looks Overseas, Doesn’t Like What it Sees

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Thanks to the folks in Washington, most anything having to do with the federal government is closed until further notice. That means fixtures like the Grand Canyon and the Library of Congress (LOC) are off-limits.

The FDA is feeling the pinch too. It’s had to send about half of its staff home, according to RAPS. FDA’s website won’t be updated, either.

The lion’s share of the pre-shutdown device-related warning letters involved overseas entities. A good example comes in a September 5, 2013 letter to Vincent Medical Manufacturing Company, based in Dong Guan City, China.

FDA kicked the tires at this manufacturer of breathing circuits and sterile fluid management injection systems, and didn’t like some of what it saw. For example, Vincent’s Corrective and Prevention Action (CAPA) failed to establish and maintain a number of procedures.  Vincent was also charged with failing to ensure that inspection and test procedures could be validated with a “high degree of assurance.”

FDA also chided Vincent for “failure to establish and maintain procedures to ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed.”

FDAlogoFDA sent an August 26 letter to Bio Focus Co., based in Uiwang, Republic of South Korea.  FDA hit that firm for an inadequate CAPA program, process validation, device design validation, management of suppliers and other outside vendors, and environmental controls, among several other issues. Bio Focus manufactures Sure-Aid pregnancy tests.

In Taiwan, FDA challenged St. Shine Optical, manufacturer of contact lenses, for several shortcomings. Shortcomings cited in the August 26 warning letter include: inadequate validation reports, design control procedures, and process controls.

Earlier in August, FDA issued a warning letter to Denmark-based Dako Denmark, manufacturer of the HER2 CISH pharmaDx kit. In the August 21 letter, FDA noted that the firm closed six CAPA’s, but failed to provide any evidence that the CAPA’s were effective.  FDA also hit the firm for inadequate process validation protocol, and complaint processing.

FDA returned to the U.S. with a September 20 letter to Medical Device Resource Corporation. The Livermore, California-based maker of the LS2 Aspirator, and the K Pump was issued a warning letter because it’s process validation, outside products, and other product controls were found lacking.

Elsewhere in California, Medtronic MiniMed was hit with, among others issues, inadequate CAPA, device control, and complaint management. That came in a September 19 warning letter.

While medical device makers may not be overly worried about a hobbled FDA, let’s all agree that it would be nice someday to be allowed to visit the Grand Canyon and the LOC again. Those are both bi-partisan places, right?

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Former FDA Inspector’s Crystal Ball: Cloudy With a Chance of Inspected Meatballs

Patrick Stone

Patrick Stone, President, TradeStoneQA

The FDA’s “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by congress. More than half of the operating funds will be earmarked for food work. International food inspections will surely be a focus area for the coming year. The inspection goals/FTEs will be set low enough for the field staff to meet or exceed expectations. This again will ensure a steady flow of billions for operating costs. In recent years large chunks of the FDA budget were set for new facilities completion and the dreaded infrastructure technology (IT) upgrades which barely seem to keep up with private industry.

Opioid labeling rules newly penned will assist in identifying and tracking legal drugs, however Internet and backstreet sales will continue to plague the market. Insurance fraud is making it easier for mail-order diversion and out right second hand sales of the legally obtained opioids. So until the insurance scams are tapered this effort will only increase operating cost for the opioid manufacturers.

A medical device tax and new user fees will be required for doing business in our domestic market. It seems that every few years the fee structure increases and becomes more complex. Maybe this is part of the reason our health care cost are always going up exponentially. What will they think of next to add to the user fee list?

compounding pharmacyThe agency has issued product specific sterile drug consent decrees and lengthy 483s for cGMP violations across the nation. There are a few sterile drug manufacturers that judging by the 483 wording will be handed consent decrees very soon. These firms are major market shareholders that have had ample time for remediation without compliance. The recalls from these same firms have been persistent all year.

The great 2013 compounding pharmacy blitz and new regulations request for these manufacturers was not so much as shock and even less awe. The faster FDA defines what compounding drug manufacturing is and provides lengthy guidance on how it should not be done in a compounding pharmacy setting, the faster we will see market self-compliance. Compounding pharmacies must recognize themselves as manufacturing entities and adhere to strict USP <797> and 21 CFR 200 standards that are costly.

Compounding pharmacies are the first line of defense when it comes to the drug shortage so they must operate in strict compliance with sterile the drug cGMP systems approach. More patients will have adverse events and possibly die from non-compliant/contaminated compounded sterile drug preparations if the mindset of the manufacturers is not changed. The State board of Pharmacy cannot shield compounders from civil or criminal liability and the FDA may soon have what it needs for implementing jurisdictional authority.

Here’s to an exciting 2014!

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

 

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FDA Hopes to Rollout New Adverse Event Reporting Tool in December

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

FDA’s Center for Devices and Radiological Health (CDRH) has finally picked a new adverse event (AE) reporting tool for devices. It’s slated to be in place by the end of the year. Of course, the agency missed a few deadlines to pick a new tool, so that deadline could slip, too.

FDAlogoThe creaky MAUDE, or Manufacturer and User Facility Device Experiences system, is out. It’ll be replaced by a PRIMO internet-based software platform developed by the November Research Group (NRG). FDA just inked a five-year contract with NRG.

While NRG touts its tool as a cut-above commercially available pharmacovigilance solutions primarily focused on generating the reports then sent to regulators, PRIMO is specifically designed for streamlined report intake and high-volume, intelligent report review, according to the company.

NRG’s tool is designed to, among other things, speed AE reporting into CDRH, and generate more accurate follow-up data returning to the device maker from the agency.

Years in the making, the upgrade was part of a concerted CDRH that included the September 2012 release of a white paper, “Strengthening Our National System for Medical Device Postmarket Surveillance.”  The white paper laid out the market conditions demanding an AE reporting system upgrade. It also included four specific calls to action:

  1. Establish a Unique Device Identification System and Promote Its Incorporation into Electronic Health Information;
  2. Promote the Development of National and International Device Registries for Selected Products;
  3. Modernize Adverse Event Reporting and Analysis; and,
  4. Develop and Use New Methods for Evidence Generation, Synthesis and Appraisal.

CDRH has said in the past that it receives more than a thousand AE’s each day.

NRG unveiled the new tool back in March.

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No FDA Guidance or Specific Regulation but Don’t Overlook the Criticality of Product Life Cycle in Medical Device Design Control

Dennis Payton, Executive Director of Product Marketing, Expandable Software, Inc.

Dennis Payton, Executive Director of Product Marketing, Expandable Software, Inc.

After a discussion of the short FDA CFR 21 Part 820 Quality System Sec. 820.30 and Sec. 820.40 on Design Control, even with the expanded FDA ‘Design Control Guidance For Medical Device Manufacturers’, there is not any mention of controlling the device lifecycle as part of the design controls. With the high degree of findings in the Design Control regulation, an important piece not discussed is the state or status of a product and definitions surrounding the Life Cycle of products. An important distinction and critical element of any Design Control fully defining a Product Life Cycle (PLC) and assigning stages of a product through a design process supplies a critical element in any general product management and can play a critical role in Medical Device audit and FDA Design Control compliance. Development of a Product Life Cycle (PLC) along with a solid Product Development Process (PDP), a topic for a later discussion, provide the provide the necessary corner stones for a complete Design Control and Device Management compliance. In this article we’ll explore the basics of a PLC to provide the basics, each manufacturing and development environment may need to adjust the model to meet the needs of the given environment but meshing the PLC with a solid PDP that align and complement each other provide a very solid Design Control base platform.

General Cradle to Grave Product Lifecycle

A simplistic product lifecycle has some very basic phases of life: research, development, production and end of life. These can certainly be expanded as needed by a specific device design & manufacturing complexity, or simplicity for that matter, as well as device class, category and classification. There can be sub-phases in the product development (prototype, engineering build, alpha, beta, archived, etc., level of product status, for example) but the main concern is to define the lifecycle that best meets the overall objective while being able to track the various product and versions of product in development, in the marketing place and archived after manufacture discontinuance (still have to support those products in the market place even though the selling cycle has ended).

The diagram below provides the basic PLC model and a generalized flow of life. A good deal of the life cycle flow should be overlaid with a device development process so while the PLC is discussed here remember that both the PLC and PDP for a given manufacturing environment should be developed in conjunction so that the two mesh well and complement each other as part of the total design control of devices.

Source: Expandable Software

Source: Expandable Software

As a Product Manager each of these phases of a product are of concern. The FDA defines some flexibility is design control as to when those controls should engage somewhere in the gray area between Research and Development mainly in an attempt to loosen up compliance a bit to help encourage research of new technologies and device for the medical industry. While the FDA being somewhat flexible in the front end research, for a Product Manager managing products even in the research phase needs some definition to help define when technology can be developed for the market place and further defined as viable for the business, market and developed into a marketable device. With the remaining PLC, the FDA will certainly want solid design controls and tracking of the device history from development through to product end-of-life (EOL) although for all purposes the EOL of products doesn’t mean that they disappear, rather they are product designs that gets archived for any reason that they might need to be revisited for support of product in the market. Here again the other end of the PLC spectrum may have deeper EOL process depending on the device(s) a manufacture is delivering to the market and how those devices live beyond the final sales.

Key points to consider in the development of a specific product life cycle (PLC) are:

  1. General enough to apply to finished product as well as supply chain components
  2. Define a solid definition between a research phase and development phase that will meet the definitions of controls for a particular product. Note: the FDA can be a bit more flexible with the research phase as far as hard and fast design documentation but best to make sure there is a clear distinction and definition built into a PLC and PDP and assure adequate regulatory coverage
  3. Perform a clear and clean hand off between Development and Production with all associated documentation approved and release. Be sure there is a process built into the PLC to review current product for meeting needs (both marketing and business) and allow for adjustments/changes as the product traverses it lifecycle
  4. Design a process around the End-Of-Life of a product both from a business perspective (not to strand any inventory, leave customers without solutions, etc.) but also from a regulatory perspective in that no product really “ends” – it rather gets archived and stored so that design history is retrievable (very much like Levi’s…they “never die they just fade away” but the history must endure). Note: although the general case of the PDP provided in previous sections has been focused primarily on the R&D and production phases of this PLC, the EOL Process is equally important to define and put in place so that product is properly archived for future reference, retrieval and audit compliance.

This short article can never do full justice to defining a full Product Life Cycle (PLC), there have likely been many books written on the topic, but the key point here is that there is not a whole lot of FDA regulation or guidance for Design Control that discuss PLC. A basic product management tool like a well-defined PLC can play a huge role in compliance to Medical Device Design Control and overlaid with a well-defined Product Development Process can help avoid design control issues, FDA finding or even worse warning letters or other punitive action. From a Product Managers perspective the earlier in the startup device manufacture and earlier in the product life that these principles can be applied the better managed the overall product can be managed both from a compliance perspective and from a business perspective. Regardless of the FDA compliance managing the product from a business perspective can pay big dividends in determinate time to market when managing the PLC married to a well-defined and practiced PDP. These PLC and PDP topics along with a perspective of FDA Design Control normalization and enterprise tools that manage the process and can accelerate time to market are discuss together in an Expandable Software white paper: “Quality System for Startup Medtech Companies: Design & Documentation Controls”.

Get the full detailed White Paper here.

About the Author

Dennis Payton is executive director of product marketing with Expandable Software Inc. He has 23 years of engineering, product management and executive management experience. He holds a BS in electrical engineering from California Polytechnic State University, San Louis Obispo, and post studies at Stanford University, University of California, Santa Cruz, and UC Berkley Haas School of Business.

 

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New Guidance Offers Clarification on IDE Requirements

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

School bells are sounding the death knell of summer across the land. But, as we’ve noted before, the FDA didn’t take much time off to enjoy surf and sand.

The agency capped a busy season last week by issuing a new guidance aimed at Investigational Review Boards, Clinical Investigators, and Sponsors when determining if an Investigational Device Application (IDE) or an Investigational New Drug Applications (IND) is warranted.

Structured in a helpful Q&A format, the guidance should make it easier for device and drug companies and other entities to understand what’s expected of them in this often gray area.

For example, the guidance reaffirms that an IRB must review the qualifications of clinical investigators who conduct FDA-regulated research.

However, the agency does illustrate some situations where there is interpretive leeway for regulated entities. “In many cases, the IRB may have previous experience with an investigator or institution that would allow the IRB to readily determine that the clinical investigator is appropriately qualified to conduct and supervise the proposed research.” If that’s the case, you’re probably okay to get started.

The guidance also reminds us clinical investigator report cards are available on the FDA website. IRBs may check the lists posted on FDA’s website to determine whether a clinical investigator has been the subject of an inspection by the agency and the results of such inspections (e.g.,Warning Letters). FDA also posts on its website a listing of all investigators who have been notified of the initiation of a disqualification proceeding or have been disqualified.

FDAlogoThe guidance also spells out the requirements to determine whether submission of an IDE application to FDA is required. That determination is based, in part, on assessing the risk factor for the device. The IDE regulations (21 CFR 812) describe three types of device studies: significant risk (SR), nonsignificant risk (NSR).

The sponsor is responsible for making the initial risk determination, and presenting it to the IRB. If the sponsor has determined that a device study is NSR, the IRB must review the sponsor’s determination. If the IRB disagrees with the sponsor’s NSR assessment and decides the study is SR, the IRB must inform the clinical investigator and, where appropriate, the sponsor. The IRB should also document its SR/NSR determination in the IRB meeting minutes.

FDA can assist sponsors, investigators, and IRBs in making the determinations. Information on how to get started can be found in the agency’s 2011 guidance Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices.

FDA’s lists of investigators it has examined can be found here:

 

 

 

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FDA Wants Your Patient Preference Input for Medical Device Regulatory Processes

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

After a surprisingly busy summer, the FDA is leaping into September with a two-day meeting where you can be the star — or on the defensive.

Mark your calendar for Sept. 18-19 at FDA headquarters in Rockville, MD for “The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes.”

FDA’s goal is to open a dialogue on the best ways to incorporate patient preferences on the benefit-risk tradeoffs of medical devices into the full spectrum of the Center for Devices and Radiological Health (CDRH) regulatory decision making.

It also aims to advance the science of measuring treatment preferences of patients, caregivers, and health care providers. The agency intends to use information gleaned from the workshop and subsequent public comments to help regulators, industry, providers, patients, and device innovators to get on the same page.

FDAlogoMeantime, FDA’s busy summer included a slew of new warning letters. In Taiwan, Soleetech Corporation, a manufacturer airway (extension) connectors, flat out told the FDA it didn’t have, and didn’t plan to develop, any kind of Corrective and Preventative Action (CAPA).

I understand that different nations have different cultural quirks, but telling the FDA you aren’t much interested in CAPA is a universally bad idea.

August was indeed a busy warning letter month. As of August 22, more than dozen had already been issued. And with the month not over, and a lag time in posting some letters, August is shaping up to be a big enforcement month.

Nearly half of August’s warning letters zeroed in on Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) alleged shortcomings. Typical of this trend was an August 8 letter to Healing Dives Inc.

So, as we all drive back from the beach, it’s time to examine FDA’s next moves. Look for an upcoming post from fellow blogger and former FDA inspector Patrick Stone with his wish list for what he views as the FDA’s most burning issues in September and beyond.

 

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Electronic Medical Records: Don’t Feel So Secure

Patrick Stone

Patrick Stone, President, TradeStoneQA

How often do we see HIPAA violations issued because a regulated entity did not secure the electronic records at the hospital and small clinics? Large scale security breaches and, sometimes, the selling of your e-records by various third party sources are in the news. In Massachusetts and New Hampshire an e-record vendor recently admitted to large scale e-record breaches. The FDA has provided some guidance on what is expected for e-records, but no real guidance on security. That may be one of the reasons that so many of the E-Systems I have reviewed meet the minimal requirements but have security vulnerabilities.

The second half of this story will send shivers down your spine, and then make you mad. Your e-records are being sold to insurance companies, debt collectors, and prospective employers. Yes your e-records are for sale to the highest bidder.  The 1996 HIPAA law left provisions for certain entities to access your entire medical record. Some of the stolen or hacked e-records get sold, and that’s terrible of course, but ironically most of the time your e-records are sold it is “legal.” Securing medical e-records comes with a price and even with some of the best security there may still be a breach. In most business models for building e-record systems security is last on the list. Sadly, it doesn’t appear to be much different in the healthcare industry.

So, what’s to be done?

doctor electronic health recordWill it take a 21st century modernization of HIPAA, written almost twenty years ago and before the e-record mandate? Or will we limp along with legislation that is increasingly showing its age?

In our digital age of e-records our security should be insured since we pay for the care we receive. HHS and congress should be focusing on this but they are currently being distracted by advocating or decrying Obamacare.

And speaking of Obamacare, that new law also has some troubling provisions about who is allowed access to your records, and some “interesting” exceptions to those provisions.

But don’t get me started on Obamacare implentation before we deal with HIPAA.

For now we can only trust (read: hope) but not verify who really has access to our medical e-records that are weakly protected by a 20th century law.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

 

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You’ve Got eMDR Questions; FDA Has (Some) Answers

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

In a new 47-page guidance the FDA appears to be doing its best to cover the waterfront for medical device manufacturers who need to better understand the complex Medical Device Reporting (MDR) requirements. Topics range from the big picture (who is subject to this rule) down to specifics (how many times must a manufacturer call a user facility for information before it can close the file).

In a perfect world, the FDA would pick an intelligent, telegenic representative and provide this information in a live Q&A format with follow-up questions from the audience. Until that day, we’ve got to rely on the new guidance, published July 9, 2013.

MDR is FDA’s mechanism to work with medical device companies to identify and monitor adverse events, with an eye to detecting and correcting problems as quickly as possible.

Medical device makers are required to report when one of its devices may have or could contribute to a death or serious injury. Device makers have between five and 30 days to report, depending on the severity of the potential adverse event.

eMDR, Electronic Medical Device Reporting

The Electronic Medical Device Reporting Process (Source: AssurX, Inc.)

We won’t try to summarize the entire document here. Instead, we’ll highlight some of the more interesting FDA “answers” to its questions.

  • How should you handle a voluntary report when you don’t know the source of it? FDA says to first evaluate the complaint to see if it is a reportable event. Base that determination on in-house information, and consider contacting a user facility, importer or other initial reporter related to the alleged event. “Your decision about whether or not the event is an MDR reportable event should be based on the findings of your evaluation,” the agency says.
  • What is a ‘remedial action,’ and are those reportable to FDA and included as part of the more urgent 5-day report? The short answer is yes. FDA wants medical device manufacturers to attack problems with a wide lens. “FDA does not consider an action taken to correct only a single device involved in an MDR reportable vent to be a remedial action.” In other words, don’t forget CAPA and root cause analysis.
  • What does FDA require for developing, maintaining, and implementing written MDR procedures? FDA says medical device manufacturers must include internal systems that provide for: timely and effective identification, communication, and evaluation of events; a standardized review process or procedure; and timely transmission of complete reports to the FDA.
  • What information contained in an MDR report is subject to public disclosure. The bad news: All of it. The good news: FDA, before releasing a MDR report subject to a Freedom of Information Act request, will delete information covering trade secrets, personal medical information, and names and other identifying information of a third party that voluntarily submits a report, e.g., physicians and other health care professionals.

Comments are due in early October. Submit them to www.regulations.gov. Include the docket number (1828) with comments. Short URL for the draft guidance document: https://federalregister.gov/a/2013-16395

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