DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets

K220643 · Htl-Strefa S.A · FMK · Jul 8, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220643
• Device Name: DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets
• Applicant: Htl-Strefa S.A
• Product Code: FMK · General, Plastic Surgery
• Decision Date: Jul 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2

Intended Use

Sterile, single use medical devices intended for capillary blood sampling.

Device Story

DropSafe/droplet Safety Lancets are sterile, single-use capillary blood sampling devices. Input: manual activation by user (push-button or contact-activated). Operation: internal spring-loaded mechanism (or spring-button for type 520) drives a stainless steel needle or blade into the skin to puncture the site; integral sharps injury prevention feature automatically retracts the needle/blade into the housing post-puncture to prevent reuse and accidental sticks. Output: a drop of capillary blood for diagnostic testing. Used in clinical or home settings by healthcare professionals or patients. The device provides a safe, single-use method for obtaining blood samples, minimizing sharps injury risk.

Clinical Evidence

No clinical trials on patients were performed. Simulated clinical use studies were conducted (2018-2019) to evaluate sharps injury prevention features per FDA guidance. All tested models passed the sharps injury prevention study requirements.

Technological Characteristics

Materials: medical grade stainless steel needle/blade, plastic resin housing, zinc-coated steel drive/return springs. Principle: spring-loaded or contact-activated puncture. Sterilization: gamma irradiation (SAL 10^-6). Shelf life: 5 years. Form factor: handheld, single-use, disposable. No software or connectivity.

Indications for Use

Indicated for capillary blood sampling in patients requiring diagnostic blood testing. Intended for use by healthcare professionals and lay users in both clinical and home settings.

Regulatory Classification

Identification

The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Special Controls

*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (b) *Single use only blood lancet without an integral sharps injury prevention feature* —(1)*Identification.* A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (c) *Multiple use blood lancet for single patient use only* —(1)*Identification.* A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that: (A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and (B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected. (vi) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use. (C) Handwashing instructions for the user before and after use of the device. (D) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device. (F) Instructions for the safe disposal of the device. (G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades. (H) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.” (B) “Used lancet blades must be safely discarded after a single use.” (C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.” (d) *Multiple use blood lancet for multiple patient use* —(1)*Identification.* A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class III (premarket approval).(3) *Date PMA or notice of completion of a PDP is required:* A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• VeriFine Safety Lancet (K192666)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.

July 8, 2022

HTL-Strefa S.A. Justyna Zemigala Regulatory Affairs Manager Adamowek 7 Ozorkow. 95-035 Poland

Re: K220643/S001

Trade/Device Name: DropSafe Acti-Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class II Product Code: FMK Dated: June 7, 2022 Received: June 13, 2022

Dear Justyna Zemigala:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### Device Name

DropSafe Acti-Lance Safety Lance Safety Lance Safety Lancets; DropSafe Medlance Plus Safety Lancets; DropSafe Prolance Safety Lancets; DropSafe Haemolance Plus Safety Lancets; DropSafe Medisafe Solo Safety Lancets; droplet ACTL-LANCE Safety Lancets; droplet MEDLANCE PLUS Safety Lancets

#### Indications for Use (Describe)

Sterile, single use medical devices intended for capillary blood sampling.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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HTL-STREFA S.A. Traditional 510(k) for DropSafe Safety Lancets and droplet Safety Lancets Submitted Under 21 CFR 807.90(e).

# 5. 510(k) Summary

[807.92 (a)(1,2)]

As required by the Safe Medical Devices Act of 1990 and in accordance with 21 CFR § 807.92(a).

Date Summary 28 February, 2022 Prepared: Submitted by: HTL-STREFA S.A. ul. Adamówek 7 95-035 Ozorków POLAND Phone: [phone] Fax: [phone] Primary Contact: Justyna Żemigała RA Manager [e-mail] Szymon Skurzyński Secondary Contact: RA Specialist [e-mail] Trade Name: DropSafe Acti-Lance Safety Lancets DropSafe ergoLance Safetv Lancets DropSafe Medlance Plus Safety Lancets DropSafe Prolance Safety Lancets DropSafe Haemolance Plus Safety Lancets DropSafe Medisafe Solo Safety Lancets droplet ACTI-LANCE Safety Lancets droplet MEDLANCE PLUS Safety Lancets Models: type 610 (DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets) type 450 (DropSafe ergoLance Safety Lancets) type 553-556 (DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets) type 430 (DropSafe Prolance Safety Lancets) type 420 (DropSafe Haemolance Plus Safety Lancets) type 520 (DropSafe Medisafe Solo Safety Lancets)

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## HTL-STREFA S.A. Traditional 510(k) for DropSafe Safety Lancets and droplet Safety Lancets Submitted Under 21 CFR 807.90(e).

| Common name: | Blood lancets |
|------------------------|--------------------------------|
| Regulation Number: | 21 CFR § 878.4850 |
| Product Code: | FMK |
| Device Classification: | II |
| Review Panel: | 79 General and Plastic Surgery |

# Predicate Device [807.92(a)(3)]

## The legally marketed devices to which substantial equivalence is claimed are:

| Manufacturer | Trade Name | 510(k) Number |
|-------------------------------------------|------------------------|---------------|
| Promisemed Hangzhou<br>Meditech Co., Ltd. | VeriFine Safety Lancet | K192666 |

# Description of Device: [807.92(a)(4)]

# Device description

DropSafe/droplet Safety Lancets and are manufactured by HTL-STREFA S.A. under different, individual brand names. The devices share intended purpose, risk class and manufacturing characteristics. DropSafe/droplet Safety Lancets are sterile, single use medical devices intended for capillary blood sampling. DropSafe/droplet Safety Lancets are OTC devices intended to be used by healthcare professionals and lay users. So far, these lancets were available on the US market as medical devices class I.

The devices have similar design and are gamma sterilized. DropSafe/droplet Safety Lancets comprise needle or blade and are offered with different gages and lengths (different skin penetration depths after puncture).

DropSafe/droplet Safety Lancets are sterile until protective cap is removed. DropSafe/droplet Safety Lancets are push-button activated or activated by pressing the device against the puncture site (contact activation). Regardless of the activation mechanism, the devices are designed to minimize the risk form accidental needle/blade sticks with a used needle/blade by application sharps prevention feature. Following use, the needle/blade retracts into the housing which prevents reuse and accidental sticks. The devices are packed in various quantities in boxes.

DropSafe/droplet Safety Lancets share the same technological design and principle of operation. The selected models comprise a needle or a blade. The only differences relate to the shape of the outer housing of the devices and the method of their activation.

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## HTL-STREFA S.A.

## Traditional 510(k) for DropSafe Safety Lancets and droplet Safety Lancets

## Submitted Under 21 CFR 807.90(e).

DropSafe/droplet Safety Lancets comprise the following common elements:

- Injection molded housing, -
- Complete needle/blade coated with a silicone as a lubricant (a steel needle/blade molded with plastic),
- Needle/blade cap. -
- -Injection molded pushbutton (in a case of push-button activated models),
- -Drive and return spring made of zinc-coated steel wire (springs drive the needles/blades that puncture the skin and retract the needle/blade).

Only the lancet type 520 (DropSafe Medisafe Solo Safety Lancets) is not spring-loaded device; the mechanism of lancet activation is operated by "spring-button" element.

# Indications for Use: [807.92(a)(5)]

Sterile, single use medical devices intended for capillary blood sampling.

# Technological Characteristics: [807.92(a)(6)]

A comparison of characteristics of DropSafe/droplet Safety Lancets and the predicate device is shown in the table below:

| | Subject Devices | Predicate Device | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Manufacturer | HTL-STREFA<br>S.A | Promisemed<br>Hangzhou<br>Meditech Co.,<br>Ltd. | |
| 510(k) number | Pending | K192666 | |
| Intended use | Sterile, single<br>use medical<br>devices intended<br>for capillary<br>blood sampling | It is intended for<br>capillary blood<br>sampling | |
| Device name | DropSafe/droplet<br>Safety Lancets:<br><br>DropSafe Acti-<br>Lance Safety<br>Lancets;<br><br>DropSafe<br>ergoLance Safety<br>Lancets; | VeriFine Safety<br>Lancet | |
| | | Submitted Under 21 CFR 807.90(e). | |
| | | DropSafe<br>Medlance Plus<br>Safety Lancets; | |
| | | DropSafe<br>Prolance Safety<br>Lancets; | |
| | | DropSafe<br>Haemolance<br>Plus Safety<br>Lancets; | |
| | | DropSafe<br>Medisafe Solo<br>Safety Lancets; | |
| | | droplet ACTI-<br>LANCE Safety<br>Lancets; | |
| | | droplet<br>MEDLANCE<br>PLUS Safety<br>Lancets | |
| Product code | | FMK | FMK |
| Materials | Needle/blade | Needle or blade<br>– medical grade<br>stainless steel | Needle – medical<br>grade stainless<br>steel |
| | Housing | Plastic resin | Plastic resin |
| | Spring | Drive and return<br>spring – stainless<br>steel wire | Drive and return<br>spring – stainless<br>steel wire |
| | Operation principle | | Manual |
| Sharp prevention feature | | Yes | Yes |
| Mechanism of lancet activation | | Push-button or<br>contact<br>activation; dual<br>spring<br>mechanism for<br>needle/blade<br>operation | Contact<br>activation; dual<br>spring<br>mechanism for<br>needle operation |
| Biocompatibility | | Conforms to ISO<br>10993-1 | Conforms to ISO<br>10993-1 |

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# HTL-STREFA S.A. Traditional 510(k) for DropSafe Safety Lancets and droplet Safety Lancets
Submitted Under 21 CFR 807.90(e).

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#### HTL-STREFA S.A. Traditional 510(k) for DropSafe Safety Lancets and droplet Safety Lancets Submitted Under 21 CER 807 90(e)

| Submitted Under 21 CFR 807.90(e). | | |
|-----------------------------------|------------------------------------------------------------------|------------------------------------------------|
| Sterility | Sterile; sterilized<br>by gamma<br>irradiation;<br>$SAL=10^{-6}$ | Sterile; sterilized<br>by gamma<br>irradiation |
| Shelf life | 5 years | 5 years |
| Packaging | Cardboard sales<br>box | Cardboard sales<br>box |

The new device and the predicate device are classified under 21 CFR § 878.4850, which states: "Single use only blood lancet with an integral sharps injury prevention feature – (1) Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use."

Based upon the above comparisons to the predicate device, DropSafe/droplet Safety Lancets do not raise any new issues of safety and effectiveness.

# Non-Clinical Performance Data: [(807.92(b)(1)]

The safety and effectiveness studies for DropSafe/droplet Safety Lancets were performed to demonstrate compliance with the established requirements by manufacturer as per product specifications. These tests were conducted by quality control and include, but are not limited to the following studies: aesthetics and correctness of assembly; no self-activation; lancet activation; minimum puncture; needle/blade retraction after activation.

Additionally non-clinical performance data were obtained after carrying out biocompatibility, sterilization and transport tests. During transport tests, the devices were exposure to mechanical hazards to check whether the pre-determined packaging method is appropriate for their transporting to distribution centers, customers and secures the devices from damage.

The reports with non-clinical performance data were appended to selected sections of this submission.

# Clinical Performance Data: [(807.92(b)(2)]

The simulated clinical use studies to evaluate sharps injury prevention features of DropSafe/droplet Safety Lancets were conducted between 2018 and 2019 in USA.

These tests were conducted by an external agency in accordance with the U.S. Food and Drug Administration's (FDA) guidance on medical devices with sharps injury prevention features (Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, issued on August 9, 2005). Based on the studies' results, all of tested types of the DropSafe/droplet Safety Lancets passed the sharps injury prevention study. The detailed reports describing the mentioned above studies were appended to this submission.

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## HTL-STREFA S.A. Traditional 510(k) for DropSafe Safety Lancets and droplet Safety Lancets Submitted Under 21 CFR 807.90(e).

# Conclusion: [807.92(b)(3)]

DropSafe/droplet Safety Lancets are substantially equivalent in the intended use, technology/principle of operation, materials and performance to the predicate devices and do not raise any new questions of safety and effectiveness.