April 19, 2014

FDA VCIP Program: Too Much Stick, Not Enough Carrot?

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It’s a growing trend in these United States: paying extra for convenience such as bypassing the riffraff in airport security lines, or whizzing past mere mortal motorists on pristine for-pay express lanes.

Where I live in the Washington, D.C. area, the new express road program in Northern Virginia’s clotted traffic arteries appears to be a hit. For a buck or two, you get out of the more crowded free lanes. And you are allowed to go 65 miles an hour, while the peasants are held to 55 mph!

On the other hand, the express lane program at Reagan National Airport doesn’t appear to be generating much traffic.

If the FDA’s new VCIP (Voluntary Compliance Improvement Program) is trying to ride the “pay for convenience” bandwagon, early anecdotal evidence suggests they’re resembling airports more than highways. We’re hearing many in industry say the VCIP program doesn’t offer enough of an incentive to take on the extra work.

Undaunted, FDA released earlier this week a document that reads like a nice, bureaucrat gently trying to convince industry to give the program a try.

The joint pilot project housed in the Center for Devices and Radiological health (CDRH) and Office of Regulatory Affairs (ORA) “differs from the FDA’s traditional oversight model by allowing firms to voluntarily self identify and correct possible regulatory violations instead of undergoing FDA inspection.”

Regulated entities have to apply to participate, but those with violations that raise “imminent” public health concerns needn’t bother.

Here’s the FDA’s big carrot: “The FDA supports using new approaches to help companies come into compliance. These approaches benefit industry and may decrease the number of inspections that the FDA performs or permit the agency to focus on manufacturers with serious and ongoing problems.”

Pacemaker150Hmm. I guess I’m not super surprised that initial industry enthusiasm appears weak. To my knowledge, FDA has not released any statistics about participation. I’m basing my very early days’ assessment on discussions with medical device firms and consultants at recent trade shows and the like. I could be wrong, and VCIP might turn out to be a big hit.

If you want to get picked, know that FDA will identify manufacturers eligible to participate in VCIP through its 2014 inspection work plan and offer them an opportunity to apply rather. For the pilot, the FDA will choose three to five applicants. Of course, their feedback, whether official or in trade show hallway conversations, will tell us a lot about the merits of VCIP.

While it promises some benefits down the road, initial participation in VCIP sounds like it will just add another layer to a device manufacturer’s compliance program. VCIP participants will be required to retain an outside expert consultant to assess their manufacturing and quality assurance systems and to monitor and certify that they are following program requirements. Firms must also demonstrate the ability to define problems, analyze root causes, create appropriate corrective actions, and verify that the actions taken were effective.

If a firm does not meet its commitments under the VCIP, or if the FDA and the firm disagree about any of the results, then the firm may be removed from the program and undergo FDA inspection, which could lead to regulatory action. If a manufacturer ends its participation in the VCIP, it would be subject to FDA inspection and any resulting regulatory action.

FDA gets to the potentially big benefits toward the end of the new VCIP document. If you are selected and pass the tests, your firm “will not be subject to routine surveillance inspection while program participation is underway.” The exemption will be good for two years after a manufacturer successfully completes the program. FDA says it will also expedite review of export certificate requests and prioritize device and pre-amendment determination requests from program participants.

Clearly it’s too early to judge whether VCIP will be a success. And FDA is to be applauded, I think, for trying something a bit new.

Still, here’s hoping VCIP becomes the equivalent of sailing down the relatively empty highway at 65 mph, while others are slogging through heavy traffic at lower speeds.



The Much-Anticipated CIP Version 5 Final Rule Released by FERC

Trey Kirkpatrick

Vice President, Energy & Utilities Compliance, AssurX Inc.

At the FERC Commission meeting on November 21, 2013, the Commission approved the CIP version 5 Standards that addresses the cyber security of the bulk electric system.  As stated in the FERC final rule, these standards are an improvement over the current effective CIP version 3 Standards.  CIP version 5 requires the industry to adopt new controls and expands the scope of systems that are protected by the CIP standards.  The Commission also approved definitions associated with the CIP Standards and directed NERC to make modifications to CIP version 5 and submit informational filings back to FERC.

FERC LogoOne of the key decisions, as requested by the ERO, was the Commission’s approval to allow registered entities to transition from currently-effective CIP version 3 Standards to compliance with CIP version 5 Standards.  The CIP version 4 approved Standards will not become effective.  CIP version 3 will remain in effect until the effective date of CIP version 5.  The Commission also approved the implementation plan and effective dates proposed by NERC.

Some of the key highlights from the FERC Order:

  • The CIP version 5 Standards identify and categorize BES Cyber Systems using a new methodology based on whether a BES Cyber System has a Low, Medium, or High Impact on the reliable operation of the bulk electric system. At a minimum, a BES Cyber System must be categorized as a Low Impact asset. Once a BES Cyber System is categorized, a responsible entity must comply with the associated requirements of the CIP version 5 Standards that apply to the impact category.
  • The CIP version 5 Standards also include 12 requirements with new cyber security controls, which address Electronic Security Perimeters (CIP-005-5), Systems Security Management (CIP-007-5), Incident Reporting and Response Planning (CIP-008-5), Recovery Plans for BES Cyber Systems (CIP-009-5), and Configuration Change Management and Vulnerability Assessments (CIP-010-1).
  • The Commission directs NERC to remove language found in 17 requirements in the CIP version 5 Standards that requires responsible entities to implement the requirements in a manner to “identify, assess, and correct” deficiencies.   We support NERC’s move away from a “zero tolerance” approach to compliance, the development of strong internal controls by responsible entities, and NERC’s development of standards that focus on the activities that have the greatest impact on Bulk-Power System reliability. However, the Commission is concerned that the proposed language is overly-vague, lacking basic definition and guidance that is needed, for example, to distinguish a successful internal control program from one that is inadequate.

Note the Commission response to the “identify, assess, and correct”

“We would prefer approaches that would not involve the placement of compliance language within the text of the Reliability Standards to address these issues. We understand that NERC has inserted the “identify, assess, and correct” language into the CIP Reliability Standard requirements to move its compliance processes towards a more risk-based model. With this objective in mind, we believe that a more appropriate balance might be struck to address the underlying concerns by developing compliance and enforcement processes that would grant NERC and the Regional Entities the ability to decline to pursue low risk violations of the Reliability Standards. Striking this balance could be accomplished through a modification to the Compliance Monitoring and Enforcement Program. We believe that such an approach would: (1) empower NERC and the Regional Entities to implement risk-based compliance monitoring techniques that avoid zero defect enforcement when appropriate; (2) allow the Commission to retain oversight over the enforcement of Reliability Standards; and (3) ensure that all Reliability Standards are drafted to be sufficiently clear and enforceable.”

  • The Commission directs NERC to develop modifications that address security controls for Low Impact assets. The adoption of the Low Impact BES Cyber Asset category will expand the protections offered by the CIP version 5 Standards to additional assets that could cause cyber security risks to the bulk electric system. Specifically, categorizing BES Cyber Systems based on their Low, Medium, or High Impact on the reliable operation of the bulk electric system, with all BES Cyber Systems being categorized as at least Low Impact, offers more comprehensive protection of the bulk electric system. However, the CIP version 5 Standards do not require specific controls for Low Impact assets nor do they contain objective criteria from which to judge the sufficiency of the controls ultimately adopted by responsible entities for Low Impact assets. The Commission directs that NERC develop modifications to the CIP version 5 Standards to address this concern. While NERC may address this concern by developing specific controls for Low Impact facilities, it has the flexibility to address it through other means, including those discussed below.
  • The Commission directs NERC to submit an informational filing one year from the effective date of this Final Rule that assesses, based on the survey results, whether the BES Cyber Asset definition will, with the 15- minute parameter, cover the assets that are necessary to ensure the reliable operation of the Bulk-Power System.
  • Commission directs NERC to create a definition of communication networks and to develop new or modified Reliability Standards that address the protection of communication networks.  The Commission also directs its staff to include the issue of protecting the nonprogrammable components of communications networks in the staff-led technical conference discussed herein.

For more information: 

NERC CIP Version 5 Implementation Plan

Version 5 Critical Infrastructure Protection Reliability Standards, Docket No. RM13-5-000

Commissioner LaFleur’s comments

Trey Kirkpatrick is Vice President of Energy and Utilities for AssurX, Inc., a leading provider of energy and utility enterprise compliance management solutions.




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.



HighPoint Solutions Announces Quality Partnership with AssurX

HighPoint SolutionsHighPoint Solutions, LLC, a premier, global provider of specialized IT services dedicated to the life sciences and healthcare industries, and AssurX, Inc., a leading Enterprise Quality Management and Regulatory Compliance Software company, are announcing the formalization of their ongoing strategic partnership.

Vice President of Quality & Compliance, Robert Lorence, said, “HighPoint’s extensive domain experience in Quality Systems and AssurX’s product CATSWeb, a very powerful Quality Management System with Training Management and Document Management “built in”, has resulted in a very robust offering for clients.” Lorence continues, “Working together we will further our ability to bring value, competitive edge, and innovative thinking to our clients in a demanding and ever-changing regulatory environment.”

AssurX has offered clients a turnkey approach to projects coupling the AssurX Professional Services Organization (APSO) for configuration and implementation of the CATSWeb product with HighPoint’s Project Management, Business Analysis and Validation services.

Jeff Mazik, Vice President of Life Science Solutions at AssurX said, “The partnership between AssurX and HighPoint allows both our companies to better serve our current and future customers. HighPoint can help their customers identify a best of breed Quality Management solution that consistently meets the customer’s particular business needs and regulatory requirements. At the same time, AssurX is able to complement its Professional Services offerings to its customers with specialized assistance in terms of validation resources and professional project management to Life Science companies located all over the world.”

About HighPoint Solutions
HighPoint Solutions is a premier, global provider of specialized IT with vertically-focused business consulting, system integration, professional service, and managed hosting solutions for life sciences and healthcare companies.   Since 2000, our 500+ consultants have provided business consulting and technology solutions that continue to deliver business value and competitive advantage to more than 140 clients globally. For more information about HighPoint Solutions and their upcoming events, please visit http://highpointsolutions.com/

About AssurX, Inc.
AssurX, Inc., provides highly regulated life science organizations with enterprise quality management and regulatory compliance solutions. With a choice of OnDemand (SaaS) or OnPremise (licensed) software delivery options, AssurX’s flexible, all-in-one system automates quality and compliance processes so issues can be centrally managed. It helps collect, organize, analyze and share information to better manage and improve quality and compliance performance everywhere in your enterprise. For more information, visit http://www.assurx.com.


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?


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.



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.


NERC Focused on Four Key Initiatives at 2013 Fall Standards and Compliance Workshop

Trey Kirkpatrick

Vice President, Energy & Utilities Compliance, AssurX Inc.

The 2013 Fall Standards and Compliance Workshop is taking place this week in Atlanta. NERC, the Regions and the industry are undertaking many initiatives. Gerry Cauley, NERC President and CEO, gave the keynote remarks today at the workshop.

Mr. Cauley addressed “Why are we make all these changes?” There is a focus on the reliability issues that would prevent a blackout and sharing these lessons learned with the industry. He is excited about the Risk-Based approach underway.

He noted a few of the accomplishments over the years with improvement in vegetation management, operational training and communication.

NERC Staff and the Board of Trustees are focused in four (4) initiatives.

  1. Standard Process Reform – Standard development has made a turn for the better. New staff changes over the last year. The RISC committee has prioritized risk and made recommendations to the Board. NERC also put an independent team of experts in place to review the standards. This produced the Industry Expert Review Report. Now the Standards Committee has the responsibility to work with the standard drafting teams to review and implement these recommendations.
  2. Compliance and Enforcement – When this all started in 2007, there were teams of auditors and checklists of items that ended up creating the wrong incentives. Mr. Cauley defines success as preventing avoidable blackouts and improving reliability. By having the registered entities monitor their own compliance, this will improve discovery using internal controls and having effective remediations. The Find, Fix and Track Reporting has received a positive response from the FERC Commission. They want NERC and the Regions to continue with the Reliability Assurance Initiative (RAI) implementation. There are currently pilots going in across four regions.
  3. Event Analysis Program/Risk Assessment – (See Reliability Assessment and Performance Analysis (RAPA) presentation). The industry is submitting reports for Category 2 or above incidents. This includes a Root Cause and Mitigation Plans. NERC has had training for a more robust Root Cause approach.
  4. Cyber and Physical Security – Everyone is aware of the concerns for a cyber attack and NERC believes that improving the standards and sharing lessons learned is the right approach. The intent is to have a smooth transition from CIP version 3 standards to the new CIP version 5 standards. Registered entities will need to have the proper internal controls in place. NERC is currently running pilot programs with volunteers for the new CIP version 5 standards. They will share these lessons learned with the industry.

AssurX will have future blogs discussing NERC’s guidance on transition from CIP version 3 to version 5. NERC encourages entities to work with their regions regarding implementation plans and keep the communication open. NERC is also refreshing their physical security guidelines and lessons learned as part of this initiative.


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:





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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